Treatment ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
41巨細胞性動脈炎57
299嚢胞性線維症288

41. 巨細胞性動脈炎


臨床試験数 : 131 薬物数 : 139 - (DrugBank : 36) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 125
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05380453
(ClinicalTrials.gov)
September 21, 202222/2/2022Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical RemissionA Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Trial to Investigate the Efficacy and Safety of Subcutaneously Administered Secukinumab in Patients With New-onset of Giant Cell Arteritis (GCA) Who Are in Clinical Remission and Eligible for Treatment With Glucocorticoid-monotherapyGiant Cell ArteritisBiological: Secukinumab 300 mg, s.c.;Drug: Placebo to match Secukinumab, s.c.Novartis PharmaceuticalsNULLRecruiting50 YearsN/AAll146Phase 3Germany
2EUCTR2021-002528-18-DK
(EUCTR)
22/02/202230/07/2021RESCUE - Effect of supplemental hydrocortisone during stress in prednisolone-induced adrenal insufficiency.RESCUE - Effect of supplemental hydrocortisone during stress in prednisolone-induced adrenal insufficiency; A multicentre, randomised, double blinded, placebo-controlled clinical trial on health-related quality of life in patients with polymyalgia rheumatica/giant cell arteritis receiving ongoing low-dose prednisolone treatment. - RESCUE Glucocorticoid-induced adrenal insufficiency
MedDRA version: 20.0;Level: LLT;Classification code 10001369;Term: Adrenal insufficiency NOS;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Hydrokortison orion
Product Name: hydrokortison
Product Code: H02AB09
INN or Proposed INN: hydrocortisone
Other descriptive name: HYDROCORTISONE
Copenhagen University Hospital RigshospitaletNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
325Phase 4Denmark
3NCT04474847
(ClinicalTrials.gov)
March 15, 202113/7/2020Abatacept for the Treatment of Giant Cell ArteritisA Randomized Double-Blind, Placebo Controlled Trial of Abatacept (CTLA4-Ig) in Giant Cell Arteritis (ABAGART)Giant Cell ArteritisDrug: Abatacept;Drug: PlaceboUniversity of PennsylvaniaNULLActive, not recruiting50 YearsN/AAll78Phase 3United States;Canada
4EUCTR2020-000622-26-DE
(EUCTR)
22/01/202117/09/2020A Proof-of-Concept Study of Guselkumab in the Treatment of Subjects with New-Onset or Relapsing Giant Cell ArteritisA Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Participants with New-Onset or Relapsing Giant Cell Arteritis - THEIA Giant Cell Arteritis
MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;France;Canada;Spain;Poland;Belgium;Israel;Germany;Italy
5EUCTR2020-000622-26-IT
(EUCTR)
18/12/202024/05/2021A Proof-of-Concept Study of Guselkumab in the Treatment of Subjects with New-Onset or Relapsing Giant Cell ArteritisA Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Participants with New-Onset or Relapsing Giant Cell Arteritis - THEIA Giant Cell Arteritis
MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Virus Diseases [C02]
Product Name: Guselkumab
Product Code: [CNTO1959]
INN or Proposed INN: GUSELKUMAB
Other descriptive name: * D.3.6.2.1 - valore :Every 4 weeks dosing of 400 mg
Product Name: Guselkumab
Product Code: [CNTO1959]
INN or Proposed INN: GUSELKUMAB
Other descriptive name: * D.3.6.2.1 - valore : Every 4 weeks dosing of 200 mg
JANSSEN CILAG INTERNATIONAL NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2France;United States;Canada;Spain;Poland;Belgium;Germany;Italy
6NCT04633447
(ClinicalTrials.gov)
December 10, 20206/11/2020A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell ArteritisA Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell ArteritisGiant Cell ArteritisDrug: Guselkumab;Drug: PlaceboJanssen Research & Development, LLCNULLRecruiting50 YearsN/AAll51Phase 2United States;Belgium;Canada;France;Germany;Israel;Italy;Poland;Spain
7NCT04239196
(ClinicalTrials.gov)
July 1, 202019/11/2019Efficacy of Tocilizumab for the Treatment of Acute AION Related to GCAOpen Label Phase II Randomized Non-comparative Study of SC Tocilizumab Associated With IV Pulse Steroid Versus IV Pulse Steroid Alone for the Treatment of Acute Anterior Ischemic Optic Neuropathy Associated With Giant Cell ArteritisGiant Cell Arteritis;Optic Ischaemic NeuropathyDrug: tocilizumab and IV steroids combination;Other: IV steroids combination aloneCentre Hospitalier National d'Ophtalmologie des Quinze-VingtsRoche ChugaiNot yet recruiting50 YearsN/AAll58Phase 2France
8NCT05394909
(ClinicalTrials.gov)
February 7, 202020/5/2022Ultra-short Glucocorticosteroids and Tocilizumab Therapy in GCA PatientsTreatment Of Giant Cell Arteritis Patients With Ultra-short Glucocorticosteroids And tociliZumab: Role of Imaging in a Observational StudyGCA;TOCILIZUMAB;Glucocorticoids;PETDrug: Tocilizumab 162Mg/0.9Ml AutoinjectorAzienda Unità Sanitaria Locale Reggio EmiliaNULLActive, not recruitingN/AN/AAll20Italy
9NCT03892785
(ClinicalTrials.gov)
January 27, 202026/3/2019MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled TrialMEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled TrialGiant Cell ArteritisDrug: Prednisone treatment;Drug: Tocilizumab treatment;Drug: Methotrexate treatment;Other: Questionnaires;Biological: Blood samplesCentre Hospitalier Universitaire DijonNULLRecruiting50 YearsN/AAll230Phase 3France
10EUCTR2018-001003-36-HR
(EUCTR)
10/04/201917/05/2019A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritisA Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis giant cell arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavrilimumab
Product Code: KPL-301
INN or Proposed INN: MAVRILIMUMAB
Other descriptive name: n/a
Trade Name: Prednisone Tablets, USP
Product Name: PredniSONE Tablets, USP
Product Code: N/A
Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand
11EUCTR2018-002826-22-FR
(EUCTR)
07/03/201921/11/2018MEthotrexate versus TOcilizumab for treatment of GIant cell Arteritis: a multicenter, randomized, controlled trial - METOGIAMEthotrexate versus TOcilizumab for treatment of GIant cell Arteritis: a multicenter, randomized, controlled trial - METOGIA
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: METOJECT
Trade Name: RoActemra
CHU Dijon BourgogneNULLAuthorised-recruitment may be ongoing or finished Female: no
Male: no
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance
12NCT03841734
(ClinicalTrials.gov)
March 20195/2/2019Study of the Benefit of Early Treatment With an Endothelin Inhibitor (Bosentan) in Patients With Sudden Blindness Due to Giant Cell Arteritis: CECIBOStudy of the Benefit of Early Treatment With an Endothelin Inhibitor (Bosentan) in Patients With Sudden Blindness Due to Giant Cell Arteritis: CECIBOArteritis, Giant Cell;Blindness and Low VisionDrug: treatmentCentre Hospitalier Universitaire de NiceNULLNot yet recruiting50 YearsN/AAll8Phase 3France
13EUCTR2018-001003-36-DE
(EUCTR)
27/02/201921/06/2018A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritisA Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis giant cell arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavrilimumab
Product Code: KPL-301
INN or Proposed INN: MAVRILIMUMAB
Other descriptive name: n/a
Trade Name: Prednisone Tablets, USP
Product Name: PredniSONE Tablets, USP
Product Code: N/A
Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.NULLNot RecruitingFemale: yes
Male: yes
70Phase 2United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand
14EUCTR2018-004072-35-FR
(EUCTR)
13/02/201906/11/2018 Study of the value of early treatment in patients with sudden blindness Study of the value of early treatment with an endothelin inhibitor (Bosentan) in patients with sudden blindness secondary to giant cell arteritis - CECIBO giant cell arteritis
MedDRA version: 20.0;Level: PT;Classification code 10003232;Term: Arteritis coronary;System Organ Class: 10007541 - Cardiac disorders ;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Trade Name: BOSENTAN MYLAN
Product Name: BOSENTAN MYLAN
CHU de NiceNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
8 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance
15NCT03711448
(ClinicalTrials.gov)
January 7, 201915/10/2018Ustekinumab for the Treatment of Relapse of Refractory Giant Cell ArteritisUstekinumab for the Treatment of Relapse of Refractory Giant Cell ArteritisPatients Relapsing Refractory Giant Cell ArteritisDrug: prednisone treatment;Drug: prednisone and ustekinumab treatment;Other: questionnaires;Biological: Blood samplesCentre Hospitalier Universitaire DijonNULLRecruiting50 YearsN/AAll38Phase 2France
16EUCTR2018-001003-36-GB
(EUCTR)
06/12/201820/06/2018A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritisA Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis giant cell arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavrilimumab
Product Code: KPL-301
INN or Proposed INN: MAVRILIMUMAB
Other descriptive name: n/a
Trade Name: Prednisone Tablets, USP
Product Name: Prednisone Tablets, USP
Product Code: N/A
INN or Proposed INN: n/a
Other descriptive name: PREDNISONE
Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 2United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand
17NCT03745586
(ClinicalTrials.gov)
December 1, 20186/11/2018Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and TocilizumabGiant Cell Arteritis Treatment With Ultra-short Glucocorticoids and TocilizumabGiant Cell ArteritisDrug: Tocilizumab;Drug: GlucocorticoidsUniversity Hospital Inselspital, BerneNULLCompleted50 YearsN/AAll18Phase 1/Phase 2Switzerland;Italy
18EUCTR2018-001003-36-IT
(EUCTR)
30/11/201811/10/2018A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritisA Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis giant cell arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavrilimumab
Product Code: KPL-301
INN or Proposed INN: MAVRILIMUMAB
Other descriptive name: n/a
Trade Name: Prednisone Tablets, USP
Product Name: PredniSONE Tablets, USP
Product Code: N/A
Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Estonia;Slovenia;Spain;Ireland;Italy;United Kingdom;Poland;Belgium;Croatia;Australia;Germany;Netherlands;New Zealand
19EUCTR2018-001003-36-BE
(EUCTR)
28/11/201816/08/2018A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritisA Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis giant cell arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavrilimumab
Product Code: KPL-301
INN or Proposed INN: MAVRILIMUMAB
Other descriptive name: n/a
Trade Name: Prednisone Tablets, USP
Product Name: PredniSONE Tablets, USP
Product Code: N/A
Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Poland;Belgium;Croatia;Australia;Germany;Netherlands;New Zealand
20EUCTR2018-001003-36-NL
(EUCTR)
13/11/201829/06/2018A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritisA Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis giant cell arteritis
MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavrilimumab
Product Code: KPL-301
INN or Proposed INN: MAVRILIMUMAB
Other descriptive name: n/a
Trade Name: Prednisone Tablets, USP
Product Name: PredniSONE Tablets, USP
Product Code: N/A
Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.NULLNot RecruitingFemale: yes
Male: yes
70Phase 2Serbia;United States;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Netherlands;Germany;New Zealand
21EUCTR2018-001003-36-SI
(EUCTR)
03/10/201830/08/2018A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritisA Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis giant cell arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavrilimumab
Product Code: KPL-301
INN or Proposed INN: MAVRILIMUMAB
Other descriptive name: n/a
Trade Name: Prednisone Tablets, USP
Product Name: PredniSONE Tablets, USP
Product Code: N/A
Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.NULLNot RecruitingFemale: yes
Male: yes
70Phase 2United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand
22EUCTR2018-001003-36-ES
(EUCTR)
08/08/201828/06/2018A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritisA Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis giant cell arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavrilimumab
Product Code: KPL-301
INN or Proposed INN: MAVRILIMUMAB
Other descriptive name: n/a
Trade Name: Prednisone Tablets, USP
Product Name: PredniSONE Tablets, USP
Product Code: N/A
Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand
23EUCTR2018-001003-36-EE
(EUCTR)
09/07/201811/06/2018A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritisA Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis giant cell arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavrilimumab
Product Code: KPL-301
INN or Proposed INN: MAVRILIMUMAB
Other descriptive name: n/a
Trade Name: Prednisone Tablets, USP
Product Name: PredniSONE Tablets, USP
Product Code: N/A
Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand
24NCT03192969
(ClinicalTrials.gov)
July 15, 201714/6/2017A Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA)A Phase III Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Combination With Glucocorticoid Treatment Compared to Glucocorticoid Monotherapy in Adults With Giant Cell ArteritisGiant Cell ArteritisDrug: Abatacept;Other: Placebo;Drug: Glucocorticoid TreatmentBristol-Myers SquibbNULLWithdrawn50 YearsN/AAll0Phase 3United States;Australia;Austria;Belgium;Bulgaria;Canada;Denmark;Estonia;France;Germany;Greece;Ireland;Italy;Netherlands;Poland;Romania;Serbia;Spain;Sweden;Switzerland;United Kingdom
25NCT02955147
(ClinicalTrials.gov)
December 1, 201631/10/2016Ustekinumab for the Treatment of Giant Cell ArteritisOpen Label Study to Test the Safety and Efficacy of Ustekinumab in Patients With Giant Cell ArteritisGiant Cell Arteritis;Temporal Arteritis;Horton's DiseaseDrug: Ustekinumab;Drug: PrednisoneMassachusetts General HospitalNULLTerminated50 YearsN/AAll13Phase 1/Phase 2United States
26EUCTR2015-001758-14-IT
(EUCTR)
08/06/201620/01/2021A study to assess the efficacy and safety of Sirukumab in the treatment ofpatients with Giant Cell Arteritis, using multiple sites, and an untreatedpatient groupA Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - NA Giant Cell Arteritis (GCA)
MedDRA version: 20.0;Level: SOC;Classification code 10047065;Term: Vascular disorders;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Trade Name: Capsule di prednisone
INN or Proposed INN: PREDNISONE
Trade Name: Prednisone Capsule
INN or Proposed INN: PREDNISONE
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone capsule
INN or Proposed INN: PREDNISONE
Other descriptive name: Prednisone
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENTNULLNot RecruitingFemale: yes
Male: yes
204Phase 3New Zealand;Sweden;United States;Spain;United Kingdom;Italy;France;Hungary;Belgium;Poland;Australia;Bulgaria;Germany;Netherlands
27EUCTR2015-001758-14-HU
(EUCTR)
15/04/201619/01/2016A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient groupA Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable Giant Cell Arteritis (GCA)
MedDRA version: 20.0;Level: HLGT;Classification code 10047116;Term: Vascular inflammations;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Encorton
Product Name: Encorton
INN or Proposed INN: prednisone
Other descriptive name: PREDNISONE
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
204Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
28EUCTR2015-001758-14-NL
(EUCTR)
04/02/201626/08/2015A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient group A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable Giant Cell Arteritis (GCA)
MedDRA version: 19.1;Level: SOC;Classification code 10047065;Term: Vascular disorders;System Organ Class: 10047065 - Vascular disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
204 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
29EUCTR2015-001758-14-BG
(EUCTR)
08/01/201621/10/2015A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient groupA Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable Giant Cell Arteritis (GCA)
MedDRA version: 19.0;Level: HLGT;Classification code 10047116;Term: Vascular inflammations;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
204Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
30EUCTR2015-001758-14-DE
(EUCTR)
18/12/201515/07/2015A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient groupA Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable Giant Cell Arteritis (GCA)
MedDRA version: 19.1;Level: HLGT;Classification code 10047116;Term: Vascular inflammations;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
204Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Belgium;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand
31EUCTR2015-001758-14-BE
(EUCTR)
14/12/201505/02/2016A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient groupA Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable Giant Cell Arteritis (GCA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
204Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
32NCT02531633
(ClinicalTrials.gov)
October 16, 20156/7/2015Efficacy and Safety Study of Sirukumab in Patients With Giant Cell ArteritisA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients With Giant Cell ArteritisGiant Cell ArteritisDrug: Sirukumab;Drug: Placebo to match sirukumab;Drug: Prednisone;Drug: Placebo to match prednisoneGlaxoSmithKlineNULLTerminated50 YearsN/AAll161Phase 3United States;Australia;Belgium;Bulgaria;France;Germany;Hungary;Italy;Netherlands;New Zealand;Poland;Spain;United Kingdom
33EUCTR2015-001758-14-ES
(EUCTR)
30/09/201531/07/2015A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient groupA Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable Giant Cell Arteritis (GCA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: GSK2973327
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
Trade Name: Prednisone Capsules
Product Name: Prednisone
INN or Proposed INN: Prednisone
Other descriptive name: Over encapsulated prednisone
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
204Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
34EUCTR2013-002778-38-EE
(EUCTR)
12/02/201513/01/2015A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritisA randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis Giant cell arteritis
MedDRA version: 17.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Gevokizumab
Product Code: S78989
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052
Institut de Recherches Internationales Servier (IRIS)NULLNot RecruitingFemale: yes
Male: yes
50Estonia;Finland;Spain;Ireland;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Norway
35EUCTR2013-002778-38-FI
(EUCTR)
04/02/201514/10/2014A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritisA randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis Giant cell arteritis
MedDRA version: 18.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Gevokizumab
Product Code: S78989
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052
Product Name: Gevokizumab
Product Code: S78989
INN or Proposed INN: Gevokizumab
Other descriptive name: XOMA 052
Institut de Recherches Internationales Servier (IRIS)NULLNot RecruitingFemale: yes
Male: yes
50Estonia;Finland;Spain;Ireland;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Poland;Denmark;Norway
36EUCTR2013-002778-38-BE
(EUCTR)
21/01/201509/12/2014A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritisA randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis Giant cell arteritis
MedDRA version: 18.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Gevokizumab
Product Code: S78989
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052
Institut de Recherches Internationales Servier (IRIS)NULLNot RecruitingFemale: yes
Male: yes
50Estonia;Finland;Spain;Ireland;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Norway
37EUCTR2013-002778-38-IE
(EUCTR)
19/01/201509/01/2015A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritisA randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis Giant cell arteritis
MedDRA version: 18.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Gevokizumab
Product Code: S78989
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052
Product Name: Gevokizumab
Product Code: S78989
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052
Institut de Recherches Internationales Servier (IRIS)NULLNot RecruitingFemale: yes
Male: yes
50Estonia;Finland;Spain;Ireland;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway
38EUCTR2013-002778-38-DK
(EUCTR)
18/12/201409/12/2014A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritisA randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis Giant cell arteritis
MedDRA version: 17.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Gevokizumab
Product Code: S78989
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052
Institut de Recherches Internationales Servier (IRIS)NULLNot RecruitingFemale: yes
Male: yes
50Estonia;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Norway
39EUCTR2013-002778-38-AT
(EUCTR)
18/12/201410/12/2014A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritisA randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis Giant cell arteritis
MedDRA version: 18.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Gevokizumab
Product Code: S78989
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052
Institut de Recherches Internationales Servier (IRIS)NULLNot RecruitingFemale: yes
Male: yes
50Estonia;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Norway
40NCT03285945
(ClinicalTrials.gov)
October 201412/10/2016FDG Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid TreatmentFluorine-18-fluorodeoxyglucose Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid Treatment - A Diagnostic Window of Opportunity?Giant Cell ArteritisDrug: PET3;Drug: PET10University of AarhusNULLCompleted50 YearsN/AAll24N/ADenmark
41EUCTR2013-002778-38-GB
(EUCTR)
29/07/201429/10/2013A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritisA randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis Giant cell arteritis
MedDRA version: 18.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Gevokizumab
Product Code: S78989
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052
Product Name: Gevokizumab
Product Code: S78989
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052
Institut de Recherches Internationales Servier (IRIS)NULLNot RecruitingFemale: yes
Male: yes
50Phase 2Estonia;Finland;Spain;Ireland;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway
42EUCTR2013-002778-38-CZ
(EUCTR)
12/02/201406/01/2014A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritisA randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis Giant cell arteritis
MedDRA version: 17.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Gevokizumab
Product Code: S78989
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052
Institut de Recherches Internationales Servier (IRIS)NULLNot RecruitingFemale: yes
Male: yes
50Phase 2Estonia;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Norway
43EUCTR2013-002778-38-ES
(EUCTR)
14/01/201418/10/2013A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritisA randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis Giant cell arteritis
MedDRA version: 16.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Gevokizumab
Product Code: S78989
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052
Laboratorios Servier SLInstitut de Recherches Internationales Servier ( IRIS ) Not RecruitingFemale: yes
Male: yes
50Estonia;Czech Republic;Canada;Finland;Belgium;Spain;Ireland;Austria;Denmark;Australia;Russian Federation;United Kingdom
44EUCTR2013-002778-38-IT
(EUCTR)
11/11/201302/10/2013A placebo-controlled, proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritisA randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis Giant cell arteritis
MedDRA version: 14.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Gevokizumab
Product Code: S78989
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052
Institut de Recherches Internationales Servier (IRIS)NULLNot RecruitingFemale: yes
Male: yes
50Phase 2Estonia;Finland;Spain;Ireland;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Belgium;Australia;Denmark
45EUCTR2011-006022-25-NL
(EUCTR)
09/10/201324/05/2013A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS Giant cell arteritis (GCA)
MedDRA version: 17.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: RoActemra
Product Name: TOCILIZUMAB SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB SC
Trade Name: PredniSONE Tablets USP, 1 mg
Product Code: Ro 001-9265/F02
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 2.5 mg
Product Code: Ro 001-9265/F03
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 5 mg
Product Code: Ro 001-9265/F04
Other descriptive name: PREDNISONE
Trade Name: Encorton
Product Code: Ro 001-9265
Other descriptive name: PREDNISONE
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Norway;Sweden
46EUCTR2011-006022-25-BE
(EUCTR)
30/09/201317/06/2013A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS Giant cell arteritis (GCA)
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000013753;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: PredniSONE Tablets USP, 1 mg
Product Code: Ro 001-9265/F02
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 2.5 mg
Product Code: Ro 001-9265/F03
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 5 mg
Product Code: Ro 001-9265/F04
Other descriptive name: PREDNISONE
Trade Name: Encorton
Product Code: Ro 001-9265
Other descriptive name: PREDNISONE
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
47EUCTR2011-006022-25-PL
(EUCTR)
09/09/201316/07/2013A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS Giant cell arteritis (GCA)
MedDRA version: 19.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB SC
Trade Name: PredniSONE Tablets USP, 1 mg
Product Code: Ro 001-9265/F02
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 2.5 mg
Product Code: Ro 001-9265/F03
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 5 mg
Product Code: Ro 001-9265/F04
Other descriptive name: PREDNISONE
Trade Name: Encorton
Product Code: Ro 001-9265
Other descriptive name: PREDNISONE
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Norway;Germany;Netherlands;Sweden
48EUCTR2011-006022-25-ES
(EUCTR)
24/06/201310/06/2013A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS Giant cell arteritis (GCA)
MedDRA version: 16.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: PredniSONE Tablets USP, 1 mg
Product Code: Ro 001-9265/F02
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 2.5 mg
Product Code: Ro 001-9265/F03
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 5 mg
Product Code: Ro 001-9265/F04
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: Encorton
Product Code: Ro 001-9265
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Portugal;Spain;Austria;Italy;United Kingdom;France;Canada;Belgium;Poland;Denmark;Netherlands;Norway;Germany;Sweden
49EUCTR2011-006022-25-DK
(EUCTR)
14/06/201314/05/2013A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS Giant cell arteritis (GCA)
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000013753;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB SC
Trade Name: PredniSONE Tablets USP, 1 mg
Product Code: Ro 001-9265/F02
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 2.5 mg
Product Code: Ro 001-9265/F03
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 5 mg
Product Code: Ro 001-9265/F04
Other descriptive name: PREDNISONE
Trade Name: Encorton
Product Code: Ro 001-9265
Other descriptive name: PREDNISONE
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden;United States;Spain;Portugal
50EUCTR2011-006022-25-PT
(EUCTR)
07/06/201322/05/2013A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS Giant cell arteritis (GCA)
MedDRA version: 14.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: PredniSONE Tablets USP, 1 mg
Product Code: Ro 001-9265/F02
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 2.5 mg
Product Code: Ro 001-9265/F03
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 5 mg
Product Code: Ro 001-9265/F04
Other descriptive name: PREDNISONE
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
250 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Netherlands;Norway;Germany;Sweden
51EUCTR2011-006022-25-DE
(EUCTR)
06/06/201313/05/2013A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS Giant cell arteritis (GCA)
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000013753;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: PredniSONE Tablets USP, 1 mg
Product Code: Ro 001-9265/F02
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 2.5 mg
Product Code: Ro 001-9265/F03
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 5 mg
Product Code: Ro 001-9265/F04
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: Encorton
Product Code: Ro 001-9265
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
52EUCTR2011-006022-25-GB
(EUCTR)
23/05/201315/05/2013A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS Giant cell arteritis (GCA)
MedDRA version: 19.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: PredniSONE Tablets USP, 1 mg
Product Code: Ro 001-9265/F02
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 2.5 mg
Product Code: Ro 001-9265/F03
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 5 mg
Product Code: Ro 001-9265/F04
Other descriptive name: PREDNISONE
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
250 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden
53EUCTR2011-006022-25-SE
(EUCTR)
16/05/201307/05/2013A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS Giant cell arteritis (GCA)
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB SC
Trade Name: PredniSONE Tablets USP, 1 mg
Product Code: Ro 001-9265/F02
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 2.5 mg
Product Code: Ro 001-9265/F03
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 5 mg
Product Code: Ro 001-9265/F04
Other descriptive name: PREDNISONE
Trade Name: Encorton
Product Code: Ro 001-9265
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
250 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
54EUCTR2011-006022-25-AT
(EUCTR)
14/05/201310/05/2013A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS Giant cell arteritis (GCA)
MedDRA version: 17.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: PredniSONE Tablets USP, 1 mg
Product Code: Ro 001-9265/F02
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 2.5 mg
Product Code: Ro 001-9265/F03
Other descriptive name: PREDNISONE
Trade Name: PredniSONE Tablets USP, 5 mg
Product Code: Ro 001-9265/F04
Other descriptive name: PREDNISONE
Trade Name: Encorton
Product Code: Ro 001-9265
Other descriptive name: PREDNISONE
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
55JPRN-UMIN000008812
2012/10/0101/10/2012Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR)Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR) - Treatment of LVV and PMR by tocilizumab mono-therapy Rheumatoid arthritistocilizumab monotherapyDepartment of Rheumatology & Clinical ImmunologySaitama Medical Center, Saitama Medical UniversitityNULLComplete: follow-up complete16years-old80years-oldMale and Female40Not selectedJapan
56NCT00305539
(ClinicalTrials.gov)
May 200621/3/2006HECTHOR: Humira to Spare Steroids in Giant Cell ArteritisHECTHOR: A Pilot Multicenter Double-blind Randomised Study of 3 Months Treatment With Humira Added to Steroids in Giant Cell ArteritisGiant Cell ArteritisDrug: adalimumab;Drug: placeboAssistance Publique - Hôpitaux de ParisAbbottCompleted50 YearsN/ABoth69Phase 3France
57NCT00004686
(ClinicalTrials.gov)
February 199424/2/2000Phase II Randomized Study of Glucocorticoids With or Without Methotrexate for Treatment of Giant Cell ArteritisGiant Cell ArteritisDrug: methotrexate;Drug: prednisoneThe Cleveland ClinicNULLCompleted50 YearsN/ABoth300Phase 2NULL

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05408910
(ClinicalTrials.gov)
July 20232/6/2022Rifaximin for Treatment of Bloating in Children and Adults With Cystic FibrosisRifaximin for Treatment of Bloating in Children and Adults With Cystic FibrosisCystic Fibrosis;Abdominal Pain;Small Bowel DiseaseDrug: Rifaximin 550 MG Oral Tablet [XIFAXAN];Drug: PlaceboWake Forest University Health SciencesEmory University;University of Minnesota;University of Texas Southwestern Medical CenterNot yet recruiting12 YearsN/AAll100Phase 2/Phase 3United States
2NCT05581056
(ClinicalTrials.gov)
February 24, 202312/10/2022Evaluation of the Evolution of Quality of Life in Relation to Naso-sinus Symptomatology Under Treatment With CFTE Modulators in Children Aged 6 to 11 Years With Cystic Fibrosis With Compatible MutationEvaluation of the Evolution of Quality of Life in Relation to Naso-sinus Symptomatology Under Treatment With CFTR Modulators in Children Aged 6 to 11 Years With Cystic Fibrosis With Compatible MutationCystic FibrosisDrug: CFTR modulatorsHospices Civils de LyonNULLNot yet recruiting6 Years11 YearsAll90France
3NCT05641298
(ClinicalTrials.gov)
February 10, 202329/11/2022Study to Determine the Efficacy&Safety of ARV-1801(ACG-701) for the Treatment of Cystic Fibrosis Pulmonary ExacerbationsA Phase 2, Randomized, DB, Placebo-controlled Study to Determine the Efficacy, Safety and PK Profile of ARV-1801 in Combination With Optimized Background Therapy for the Treatment of Pulmonary Exacerbations in Patients With Cystic FibrosisCystic Fibrosis;Cystic Fibrosis Pulmonary ExacerbationDrug: Sodium Fusidate;Drug: PlaceboAceragenNULLRecruiting12 YearsN/AAll80Phase 2United States
4NCT05548283
(ClinicalTrials.gov)
February 1, 202316/9/2022Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside StudyStandardizing Treatments for Pulmonary Exacerbations: A Platform for Evaluating Treatment Decisions to Improve Outcomes (STOP360) Aminoglycoside Study (AG Study)Cystic Fibrosis;Cystic Fibrosis Pulmonary ExacerbationDrug: Beta-lactam antibiotic;Drug: AminoglycosideChris GossUniversity of Washington;Medical University of South Carolina;Cystic Fibrosis FoundationNot yet recruiting6 YearsN/AAll730Phase 4NULL
5NCT05743946
(ClinicalTrials.gov)
February 202315/2/2023Trikafta for Patients With Non-cystic Fibrosis BronchiectasisEvaluating Trikafta for the Treatment of Patients With Non-cystic Fibrosis Bronchiectasis (NCFBE)Non-cystic Fibrosis BronchiectasisDrug: TrikaftaEmory UniversityThe Marcus Foundation, Inc.Recruiting18 YearsN/AAll30Phase 4United States
6NCT05561764
(ClinicalTrials.gov)
January 3, 202327/9/2022Imipenem/Cilastatin/Relebactam Pharmacokinetics, Safety, and Outcomes in Adults and Adolescents With Cystic FibrosisA Multicenter, Open-label Study to Determine the Pharmacokinetics, Safety, and Outcomes of Imipenem/Cilastatin/Relebactam During Treatment of Acute Pulmonary Exacerbations in Adolescent and Adult Patients With Cystic FibrosisCystic Fibrosis;Pneumonia, BacterialDrug: Imipenem/Cilastatin/RelebactamHartford HospitalMerck Sharp & Dohme LLC;Q2 Solutions;Connecticut Children's Medical Center;St. Christopher's Hospital for Children;University of Texas Southwestern Medical Center;University of Pittsburgh Medical Center;Indiana University Health Methodist Hospital;James Whitcomb Riley Hospital for ChildrenRecruiting12 YearsN/AAll16Phase 4United States
7NCT05530278
(ClinicalTrials.gov)
September 20, 20225/9/2022A Study to Assess the Pharmacokinetics and Safety of Co-administered Oral Galicaftor, Navocaftor, and ABBV-576 in Healthy Adults for the Treatment of Cystic FibrosisAssessment of Multiple-Dose Pharmacokinetics and Safety of the Co-administration of Galicaftor, Navocaftor and ABBV-576 and Potential of ABBV-576 for CYP3A Induction in Healthy VolunteersHealthy VolunteersDrug: Galicaftor;Drug: ABBV-576;Drug: Navocaftor;Drug: MidazolamAbbVieNULLCompleted18 Years65 YearsFemale24Phase 1United States
8NCT05599230
(ClinicalTrials.gov)
September 1, 202221/10/2022Daily Monitoring of Respiratory Symptoms and Spirometry During ETI Treatment in Persons With Cystic Fibrosis.Daily Monitoring of Respiratory Symptoms and Spirometry During ETI Treatment in Persons With Cystic Fibrosis.Cystic FibrosisDrug: Elexacaftor 100 MG / Ivacaftor 75 MG / Tezacaftor 50 MG, 2 tablets each morning + Ivacaftor 150 mg one tablet each eveningCHC MontlegiaNULLActive, not recruiting12 YearsN/AAll20Belgium
9NCT05095246
(ClinicalTrials.gov)
March 8, 202227/8/2021A Study of Inhaled KB407 for the Treatment of Cystic FibrosisA Phase I Study of Inhaled KB407, a Replication-Incompetent, Non-Integrating Vector Expressing Human Cystic Fibrosis Transmembrane Conductance Regulator (CFTR), for the Treatment of Cystic FibrosisCystic FibrosisBiological: KB407 (Nebulization)Krystal Biotech, Inc.Novotech (Australia) Pty LimitedRecruiting18 YearsN/AAll13Phase 1Australia
10EUCTR2020-005931-58-FR
(EUCTR)
02/04/202104/02/2021ACTIVE : ACid tranexamic or Terlipressin for Initial emergency treatment of mild to seVere hEmoptysisACTIVE : ACid tranexamic or Terlipressin for Initial emergency treatment of mild to seVere hEmoptysis - ACTIVE Hemoptysis, whatever the cause, with the exception of cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: GLYPRESSINE 1 mg/5 mL, poudre et solvant pour solution injectable (I.V.)
INN or Proposed INN: TERLIPRESSIN
Other descriptive name: Terlipressin acetate
Trade Name: ACIDE TRANEXAMIQUE MYLAN 0,5 g/ 5 mL, solution injectable
INN or Proposed INN: TRANEXAMIC ACID
Other descriptive name: TRANEXAMIC ACID
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
315Phase 3France
11EUCTR2016-004558-13-DE
(EUCTR)
01/12/202009/04/2020A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3Portugal;France;United States;Greece;Canada;Argentina;Poland;Germany;Italy
12NCT02547116
(ClinicalTrials.gov)
December 20209/9/2015Epidemiology and Treatment of Small-colony Variant Staphylococcus Aureus in Cystic FibrosisEpidemiology and Treatment of Small-colony Variant Staphylococcus Aureus in Cystic FibrosisCystic Fibrosis;MRSADrug: RifampinJohns Hopkins UniversityNULLWithdrawn12 YearsN/AAll0Phase 4United States
13NCT04322929
(ClinicalTrials.gov)
November 12, 202024/3/2020Roflumilast in Non-CF Bronchiectasis Study (2019)Anti-inflammatory Effects of Roflumilast Treatment for 12 Weeks in Stable-state Non-cystic Fibrosis BronchiectasisNon-cystic Fibrosis BronchiectasisDrug: Roflumilast Oral TabletThe University of Hong KongNULLRecruiting18 YearsN/AAll27Phase 2Hong Kong
14EUCTR2016-004558-13-IT
(EUCTR)
19/10/202021/10/2020A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasischronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasischronically infected with Pseudomonas aeruginosa (P. aeruginosa) - Promis II Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin
Product Name: Colistimethate sodium
Product Code: [NA]
Other descriptive name: Colistimethate Sodium
Trade Name: Salbutamol-ratiopharm® N metered-dose aerosol inhaler
Product Name: Salbutamol-ratiopharm® N metereddose aerosol inhaler
Product Code: [Salbutamol]
INN or Proposed INN: SALBUTAMOL
Other descriptive name: Salbutamol
ZAMBON SPANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3Portugal;United States;France;Greece;Canada;Argentina;Poland;Germany;Italy
15EUCTR2020-001762-11-GB
(EUCTR)
17/09/202023/07/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
16EUCTR2020-001762-11-HU
(EUCTR)
26/08/202002/07/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
17EUCTR2016-004558-13-PT
(EUCTR)
27/07/202020/04/2020A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3France;United States;Portugal;Greece;Canada;Argentina;Poland;Germany;Italy
18NCT04553419
(ClinicalTrials.gov)
July 27, 202011/9/2020Antibiotic Treatment Of Staphylococcus Aureus In Stable People With CFAntibiotic Treatment Of Staphylococcus Aureus In Stable People With CF (ASAP-CF) Clinical Research ProtocolCystic FibrosisDrug: Cephalexin;Drug: PlaceboUniversity of British ColumbiaThe Hospital for Sick ChildrenRecruiting3 Years17 YearsAll86Phase 3Canada
19NCT04458129
(ClinicalTrials.gov)
July 8, 202030/6/2020Polyethylene Glycol and Intestinal Inflammation in Cystic FibrosisEFFECT OF POLYETHYLENE GLYCOL TREATMENT ON INTESTINAL INFLAMMATION ASSOCIATED WITH CYSTIC FIBROSIS IN CHILDRENCystic FibrosisDrug: Treatment with polyethylene glycol (Macrogol 4000)University Hospital, BordeauxNULLNot yet recruiting4 Years17 YearsAll23Phase 2NULL
20EUCTR2016-004558-13-GR
(EUCTR)
07/07/202014/05/2020A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3Portugal;France;United States;Canada;Greece;Argentina;Poland;Australia;Israel;Germany;Italy;New Zealand
21ChiCTR2000031817
2020-04-302020-04-11Evaluation and comparison of quality of life between acetylcysteine tablets and placebo in patients with non cystic fibrosis bronchiectasisA Randomized, Double-Blinded, Placebo-Controlled, Multiple-Center Clinical Trial to Compare the Quality of Life of Acetylcysteine Tablets 600 Mg BID Treatment With Placebo in Patients With Non-Cystic Fibrosis Bronchiectasis bronchiectasiaexperimental group:Acetylcysteine;control group:placebo;West China Hospital, Sichuan UniversityNULLPending18Bothexperimental group:79;control group:40;Phase 4China
22EUCTR2019-004958-29-FR
(EUCTR)
07/04/202004/06/2020Polyethylene glycol and intestinal inflammation in cystic fibrosisEFFECT OF POLYETHYLENE GLYCOL TREATMENT ON INTESTINAL INFLAMMATION ASSOCIATED WITH CYSTIC FIBROSIS IN CHILDREN - MUCOLAX Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: FORLAX 4 g, poudre pour solution buvable en sachetCHU de BordeauxNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
23Phase 2France
23NCT04235140
(ClinicalTrials.gov)
February 24, 202015/1/2020Long-term Safety of Lumacaftor/Ivacaftor in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment InitiationA Phase 3, Open-label, and Rollover Study to Evaluate the Long-term Safety and Tolerability of Lumacaftor/Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment InitiationCystic FibrosisDrug: LUM/IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting12 MonthsN/AAll52Phase 3United States;Canada
24NCT04259970
(ClinicalTrials.gov)
January 13, 202015/1/2020Hyperpolarized Imaging for New TreatmentsHyperpolarized Imaging for New Treatments (HyPOINT) StudyCystic FibrosisDrug: Initiation of CFTR ModulatorChildren's Hospital Medical Center, CincinnatiUniversity of Virginia;University of Wisconsin, Madison;The Hospital for Sick ChildrenActive, not recruiting6 Years18 YearsAll64Phase 4United States;Canada
25EUCTR2019-001314-41-NL
(EUCTR)
06/05/201906/05/2019This study investigates the effect of switching from Orkambi treatment to Symkevi. In particuar we want to investigate the effect of the switch on the uptake, concentration in the blood an degradation of ivacaftor.Kinetics of ivacaftor at Switch Orkambi Symkevi study - SOS Cystic fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Orkambi: contains lumacaftor and ivacaftor
Product Name: Orkambi
Trade Name: Symkevi
Product Name: Symkevi
Trade Name: Kalydeco
Product Name: Kalydeco
NULLNot RecruitingFemale: yes
Male: yes
100Phase 4Netherlands
26NCT03795363
(ClinicalTrials.gov)
April 10, 201928/12/2018Orkambi Treatment in 2 to 5 Year Old Children With CFNutritional Impact of Orkambi Treatment in 2 to 5 Year Old Children Homozygous for F508del MutationsCystic FibrosisDrug: OrkambiChildren's Hospital of PhiladelphiaVertex Pharmaceuticals IncorporatedCompleted2 Years5 YearsAll28United States
27NCT03632525
(ClinicalTrials.gov)
February 22, 201921/6/2018Intravenous Iron in Adults With Cystic FibrosisA Pilot Trial of Intravenous Iron for the Treatment of Iron Deficiency in Adult Patients With Cystic FibrosisCystic Fibrosis;Iron-deficiencyDrug: Ferric carboxymaltoseUniversity of OxfordNULLCompleted18 YearsN/AAll20Phase 4United Kingdom
28NCT03783286
(ClinicalTrials.gov)
February 6, 201918/12/2018Ivacaftor Treatment in 4 Month to 2 Year Old CF SubjectsNutritional Impact of Ivacaftor Treatment in 4 Month to 2 Year Old Children With CF Gating MutationsCystic FibrosisDrug: IvacaftorChildren's Hospital of PhiladelphiaVertex Pharmaceuticals IncorporatedCompleted4 Months2 YearsAll15United States
29EUCTR2015-002743-33-NL
(EUCTR)
14/12/201818/07/2018A clinical trial to investigate the efficacy and safety of inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin/Tadim
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Zambon S.p.A.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Netherlands;Germany;New Zealand
30NCT03624101
(ClinicalTrials.gov)
December 1, 20187/8/2018Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon MutationsNovel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon MutationsCystic FibrosisDrug: Trikafta;Drug: symdeko/Trikafta;Drug: Ivacaftor/TrikaftaUniversity of Alabama at BirminghamNULLRecruiting18 YearsN/AAll2Phase 4United States
31EUCTR2015-002743-33-GR
(EUCTR)
27/11/201814/11/2018A clinical trial to investigate the efficacy and safety of inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin/Tadim
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Zambon S.p.A.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3New Zealand;Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands
32EUCTR2017-002968-40-PL
(EUCTR)
31/10/201829/06/2018A Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in subjects with cistic fibrosisA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation - Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Subjects Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150mg
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
121Phase 3France;United States;Canada;Belgium;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
33NCT03265288
(ClinicalTrials.gov)
October 10, 201821/2/2017Study of LAU-7b in the Treatment of Cystic Fibrosis in AdultsAPPLAUD: A Double-Blind, Randomized, Placebo-Controlled, Phase II Study of the Efficacy and Safety of LAU-7b in the Treatment of Cystic Fibrosis in AdultsCystic FibrosisDrug: LAU-7b;Drug: Placebo oral capsuleLaurent Pharmaceuticals Inc.Cystic Fibrosis FoundationCompleted18 YearsN/AAll166Phase 2United States;Australia;Canada
34EUCTR2018-002366-39-GB
(EUCTR)
23/08/201820/06/2019A pilot trial of intravenous iron for the treatment of low iron levels in adult patients with cystic fibrosis.A pilot trial of intravenous iron for the treatment of iron deficiency in adult patients with cystic fibrosis - Intravenous iron in adults with cystic fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ferinject
Product Name: Ferinject
INN or Proposed INN: Ferric carboxymaltose
University of Oxford / Clinical Trials and Research GovernanceNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
35NCT04732910
(ClinicalTrials.gov)
July 1, 201825/1/2021Cystic Fibrosis Transmembrane Regulator (CFTR) Biomarker Study to Evaluate the Rescue of Mutant CFTR in Patients With Cystic Fibrosis Treated With CFTR-modulatorsCFTR Biomarker Studie Bei Patient*Innen Mit Mukoviszidose Und CFTR-ModulatortherapieCystic FibrosisDrug: Treatment with cystic fibrosis transmembrane regulator (CFTR) modualtors Ivacaftor, Lumacaftor-Ivacaftor, Tezacaftor-Ivacaftor, Elexacaftor-Tezacaftor-IvacaftorCharite University, Berlin, GermanyHannover Medical School;Heidelberg University;University of GiessenRecruiting6 MonthsN/AAll90Germany
36EUCTR2017-002968-40-DK
(EUCTR)
28/06/201824/06/2018A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic FibrosisA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Trade Name: Symkevi
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150mg
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
121Phase 3France;United States;Canada;Poland;Belgium;Ireland;Australia;Denmark;Germany;United Kingdom;Switzerland
37EUCTR2017-002968-40-GB
(EUCTR)
28/06/201807/03/2018A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic FibrosisA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Trade Name: Symkevi
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150mg
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
121Phase 3France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;Switzerland;United Kingdom
38EUCTR2017-002968-40-BE
(EUCTR)
26/06/201830/03/2018A study lasting 220 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic FibrosisA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Trade Name: Symkevi
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150mg
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
121Phase 3France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;Switzerland;United Kingdom
39NCT04278040
(ClinicalTrials.gov)
June 20, 20187/2/2020Inhalations of Ultra-low Doses of Melphalan for the Treatment of Non-cystic Fibrosis BronchiectasisSafety, Tolerability and Efficacy of Ultra-low Doses of Alkylating Drug Melphalan Inhalations for the Treatment of Non-cystic Fibrosis BronchiectasisNon-cystic Fibrosis BronchiectasisDrug: MelphalanFederal State Budgetary Institution, Pulmonology Scientific Research InstituteMoscow State University of Medicine and DentistryRecruiting18 Years70 YearsAll7Phase 2Russian Federation
40EUCTR2016-002749-42-NL
(EUCTR)
09/05/201829/08/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 22.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Netherlands;Germany
41EUCTR2017-002968-40-IE
(EUCTR)
27/04/201808/03/2018A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic FibrosisA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Trade Name: Symkevi
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150mg
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
121Phase 3France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
42NCT03537651
(ClinicalTrials.gov)
April 25, 201815/5/2018A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Subjects With an F508del CFTR MutationA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR MutationCystic FibrosisDrug: TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting6 YearsN/AAll130Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Ireland;Poland;Switzerland;United Kingdom
43NCT03460704
(ClinicalTrials.gov)
January 29, 201814/2/2018Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium (PROMIS II)A Double-blind, Placebo-controlled, Multi-centre, Clinical Trial to Investigate the Efficacy and Safety of 12 Months of Therapy With Inhaled Colistimethate Sodium in the Treatment of Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected With Pseudomonas Aeruginosa (P. Aeruginosa)Non Cystic Fibrosis BronchiectasisDrug: Colistimethate sodium;Drug: Saline SolutionZambon SpANULLCompleted18 Years90 YearsAll287Phase 3United States;Argentina;Australia;Canada;France;Germany;Greece;Israel;Italy;New Zealand;Poland;Portugal
44EUCTR2016-002749-42-GR
(EUCTR)
12/01/201803/10/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
45EUCTR2016-002749-42-DK
(EUCTR)
15/12/201711/10/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 21.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
46EUCTR2016-002749-42-FR
(EUCTR)
12/12/201701/08/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
47NCT03219164
(ClinicalTrials.gov)
November 28, 201713/7/2017Safety and Efficacy of 2 Treatment Regimens of Aztreonam for Inhalation Solution in Children With Cystic Fibrosis and New Onset Pseudomonas Aeruginosa InfectionRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects With Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas Aeruginosa (PA) Infection/ColonizationPseudomonas Aeruginosa Respiratory Tract Infection;Cystic FibrosisDrug: AZLI;Drug: PlaceboGilead SciencesNULLCompleted3 Months18 YearsAll149Phase 3United Kingdom;Austria;Belgium;Denmark;France;Germany;Greece;Israel;Italy;Netherlands;Spain;United States
48EUCTR2016-002749-42-IT
(EUCTR)
24/11/201714/09/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
49EUCTR2016-002749-42-GB
(EUCTR)
09/10/201725/07/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 21.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands
50EUCTR2016-002749-42-DE
(EUCTR)
22/09/201702/08/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 22.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
51NCT03181932
(ClinicalTrials.gov)
September 20, 20171/6/2017AeroVanc in the Treatment of Methicillin-resistant Staphylococcus Aureus Infection in Patients With Cystic FibrosisA Phase III, Randomized, Double-blind, Placebo-controlled Study of AeroVanc for the Treatment of Persistent Methicillin-resistant Staphylococcus Aureus Lung Infection in Cystic Fibrosis PatientsMRSA;Cystic FibrosisDrug: Vancomycin inhalation powder;Drug: Placebo inhalation powderSavara Inc.NULLCompleted6 YearsN/AAll188Phase 3United States;Canada
52EUCTR2017-000571-85-GB
(EUCTR)
19/09/201711/05/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Level: LLT;Classification code 10073392;Term: Pancreatic exocrine insufficiency;System Organ Class: 100000173123;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Hungary;Poland;Spain;Lithuania;Israel;United Kingdom
53EUCTR2016-002749-42-BE
(EUCTR)
18/09/201724/07/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
54EUCTR2017-000571-85-LT
(EUCTR)
15/09/201720/07/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis
MedDRA version: 20.0;Level: LLT;Classification code 10073392;Term: Pancreatic exocrine insufficiency;System Organ Class: 100000173123
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Hungary;Poland;Spain;Lithuania;Israel
55NCT02769637
(ClinicalTrials.gov)
September 7, 201710/5/2016Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)Cystic FibrosisDrug: PPI treatmentUniversity of Colorado, DenverCystic Fibrosis FoundationTerminated10 Years21 YearsAll2United States
56EUCTR2015-001997-16-IE
(EUCTR)
17/08/201711/04/2017A study to assess the safety, pharmacokinetics, and pharmacodynamics of ivacaftor in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3, 2-Part, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Ivacaftor-responsive CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
35Phase 3United States;Canada;Ireland;Germany;United Kingdom
57NCT03277196
(ClinicalTrials.gov)
August 16, 20176/9/2017A Study to Evaluate the Safety of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive MutationA Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive MutationCystic FibrosisDrug: IvacaftorVertex Pharmaceuticals IncorporatedNULLActive, not recruiting0 Months24 MonthsAll86Phase 3United States;Australia;Canada;Germany;Ireland;United Kingdom
58EUCTR2016-004558-13-PL
(EUCTR)
14/08/201730/06/2017A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3United States;Portugal;France;Canada;Greece;Argentina;Poland;Australia;Israel;Germany;New Zealand;Italy
59EUCTR2016-002749-42-AT
(EUCTR)
07/08/201727/07/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 21.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
60EUCTR2016-002749-42-ES
(EUCTR)
04/08/201708/08/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
61EUCTR2017-001379-21-GB
(EUCTR)
01/08/201720/07/2017A study to assess the safety and pharmacodynamics of long-term ivacaftor treatment in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 3United States;Canada;Ireland;Germany;United Kingdom
62NCT02819856
(ClinicalTrials.gov)
July 21, 201716/6/2016SPI-1005 for Prevention and Treatment of Tobramycin Induced OtotoxicityA Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Cystic Fibrosis (CF) Patients With Acute Pulmonary Exacerbation (APE) Receiving IV Tobramycin at Risk for OtotoxicityOtotoxicityDrug: Placebo;Drug: SPI-1005 Ebselen 200mg Capsule x1;Drug: SPI-1005 Ebselen 200mg Capsule x2;Drug: SPI-1005 Ebselen 200mg Capsule x3Sound Pharmaceuticals, IncorporatedMedical University of South Carolina;Cystic Fibrosis FoundationEnrolling by invitation18 YearsN/AAll80Phase 2United States
63EUCTR2015-002743-33-PT
(EUCTR)
13/07/201710/07/2017A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin/Tadim
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands;New Zealand
64EUCTR2017-000571-85-HU
(EUCTR)
15/06/201713/04/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
192Phase 3United States;Hungary;Poland;Spain;Lithuania;Israel
65NCT03066453
(ClinicalTrials.gov)
June 13, 201723/2/2017Evaluation of Short Antibiotic Combination Courses Followed by Aerosols in Cystic FibrosisEvaluation of an Antibiotic Treatment With 14 Days of Intravenous Tobramycin Versus the Same Antibiotic Associated With 5 Days of Intravenous Tobramycin Followed by Tobramycin Aerosol for 9 Days in Cystic Fibrosis.Cystic FibrosisDrug: Tobi Inhalant Product;Drug: NebcinUniversity Hospital, LilleNULLTerminated8 YearsN/AAll23Phase 3France
66NCT03093974
(ClinicalTrials.gov)
June 6, 20179/3/2017Long Term Efficacy and Safety of Inhaled Colistimethate Sodium in Bronchiectasis Subjects With Chronic Pseudomonas Aeruginosa Infection.A Double-blind, Placebo-controlled, Multi-centre, Clinical Trial to Investigate the Efficacy and Safety of 12 Months of Therapy With Inhaled Colistimethate Sodium in the Treatment of Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected With Pseudomonas Aeruginosa (P. Aeruginosa)Non Cystic Fibrosis BronchiectasisDrug: Colistimethate Sodium;Drug: Saline SolutionZambon SpANULLCompleted18 YearsN/AAll377Phase 3Australia;Belgium;Germany;Greece;Israel;Italy;Netherlands;New Zealand;Portugal;Spain;Switzerland;United Kingdom
67EUCTR2017-000571-85-ES
(EUCTR)
01/06/201721/04/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Hungary;Poland;Spain;Lithuania;Israel
68EUCTR2016-004558-13-FR
(EUCTR)
30/05/201720/03/2017A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 19.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLNot RecruitingFemale: yes
Male: yes
264Phase 3Portugal;United States;France;Greece;Canada;Poland;Germany;Italy
69EUCTR2015-002743-33-DE
(EUCTR)
29/05/201701/03/2017A clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin/Tadim
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands;New Zealand
70NCT03125395
(ClinicalTrials.gov)
May 12, 201719/4/2017A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationA Phase 3, Rollover Study to Evaluate the Safety of Long-term Treatment With Lumacaftor/Ivacaftor Combination Therapy in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: LUM/IVAVertex Pharmaceuticals IncorporatedNULLCompleted2 YearsN/AAll57Phase 3United States;Canada
71EUCTR2016-004996-33-ES
(EUCTR)
03/05/201710/03/2017A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del-CFTR MutationA Phase 4, Open-label Treatment, Randomized, Multicenter, 2-arm, Parallelgroup, Pilot Study of Adherence to Lumacaftor/Ivacaftor in CF Subjects Homozygous for the F508del-CFTR Mutation Cystic fibrosis subjects Homozygous for the F508del-CFTR Mutation
MedDRA version: 19.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Orkambi
Product Name: Orkambi
INN or Proposed INN: Lumacaftor
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVACAFTOR
Vertex Pharmaceuticals IncoporatedNULLNot RecruitingFemale: yes
Male: yes
75Phase 4United States;Canada;Spain;Australia;United Kingdom
72NCT03051490
(ClinicalTrials.gov)
April 28, 20179/2/2017RESULT: Reliable, Emergent Solution Using Liprotamase TreatmentA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic InsufficiencyExocrine Pancreatic Insufficiency;Cystic FibrosisDrug: Liprotamase;Drug: porcine PERTAnthera PharmaceuticalsNULLUnknown status7 YearsN/AAll140Phase 3United States;Hungary;Israel;Lithuania;Poland;Spain;United Kingdom
73EUCTR2016-001619-19-NL
(EUCTR)
27/03/201727/03/2017Genistein as an add-on treatment for CF?Genistein as an add-on treatment for CF? - Cystic Fibrosis
;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Genistein
INN or Proposed INN: genistein
Other descriptive name: GENISTEIN
UMC UtrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Netherlands
74NCT03256799
(ClinicalTrials.gov)
March 17, 201718/8/2017Evaluation of Ivacaftor in Patients Using Ataluren for Nonsense MutationsAn Open Label Study to Investigate the Role of Ivacaftor for the Treatment of Cystic Fibrosis in Combination With Ataluren (PTC124) in Cystic Fibrosis Patients Using Ataluren for Nonsense MutationsCystic FibrosisDrug: Ivacaftor/AtalurenUniversity of Alabama at BirminghamNULLCompleted19 YearsN/AAll1Phase 4United States
75EUCTR2015-002743-33-ES
(EUCTR)
13/03/201710/02/2017A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 19.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin/Tadim
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
264Phase 3Portugal;Belgium;Spain;Germany;Italy;United Kingdom
76EUCTR2015-002743-33-IT
(EUCTR)
02/03/201725/01/2021A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - Promis 1 Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin/Tadim
Product Name: Colistimethate sodium
Product Code: [-]
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: -
Trade Name: Ventolin¿ Evohaler¿
Product Name: Ventolin
Product Code: [Ventolin]
INN or Proposed INN: SALBUTAMOL
Other descriptive name: Ventolin® Evohaler
ZAMBON SPANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands;New Zealand
77EUCTR2015-002743-33-GB
(EUCTR)
21/02/201713/12/2016A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin/Tadim
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3Portugal;Greece;Spain;Israel;United Kingdom;Italy;Switzerland;France;Belgium;Australia;Germany;Netherlands;New Zealand
78NCT02888730
(ClinicalTrials.gov)
February 16, 201722/6/2016Tobramycin Delivered by Nebulized Sonic Aerosol for Chronic Rhinosinusitis Treatment of Cystic Fibrosis PatientsEfficacy of Antibiotic (Tobramycin) Delivered by Nebulized Sonic Aerosol for Chronic Rhinosinusitis Treatment of Cystic Fibrosis Patients: A Multicenter Double-blind Randomized Controlled TrialCystic Fibrosis;Rhinosinusitis;Lung DiseasesDrug: Tobramycin nebulized nasally;Drug: Physiologic serum nebulized nasallyVirginie ESCABASSEHenri Mondor University HospitalTerminated7 YearsN/AAll86Phase 3France
79NCT03256968
(ClinicalTrials.gov)
January 27, 201718/8/2017PTC Study to Evaluate Ataluren in Combination With IvacaftorAn Open Label N of 1 Study to Evaluate the Study and Efficacy of Long-Term Treatment With Ivacaftor in Combination With Ataluren (PTC124) in Subjects With Nonsense Mutation Cystic FibrosisCystic FibrosisDrug: AtalurenUniversity of Alabama at BirminghamNULLCompleted6 YearsN/AAll1Phase 4United States
80EUCTR2015-003399-58-DK
(EUCTR)
14/01/201707/01/2016Can antibiotic treatment improve the prognosis of Pseudomonas aeruginosa infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis and asthma?Target-ABC (Targeted AntiBiotics for Chronic pulmonary disease):Can targeted antibiotic therapy improve the prognosis of Pseudomonas aeruginosa infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis and asthma? - Target-ABC (Targetted AntiBiotics for Chronic pulmonary disease) Respiratory tract infection Bacterial infection with Pseudomonas aeruginosaChronic obstructive pulmonary disease (COPD)Non-cystic fibrosis bronchiectasisAsthma
MedDRA version: 20.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Ciprofloxacin
INN or Proposed INN: ciprofloxacin hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE
Product Name: Piperacillin/Tazobactam
INN or Proposed INN: piperacillin sodium , tazobactam sodium
Other descriptive name: PIPERACILLIN SODIUM
COP:TRIN Region Hovedstaden (Gentofte hospital)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4Denmark
81NCT02894684
(ClinicalTrials.gov)
January 20171/9/2016Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic FibrosisAztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis. An Randomised, Crossover Pilot Study of AZLI Plus Intravenous Colistin® Versus Standard Dual Intravenous TherapyCystic Fibrosis;Infection;PseudomonasDrug: Aztreonam;Drug: Standard CareLiverpool Heart and Chest Hospital NHS Foundation TrustUniversity of LiverpoolCompleted16 Years65 YearsMale16Phase 4United Kingdom
82EUCTR2016-002832-34-GB
(EUCTR)
11/11/201603/10/2016The use of an inhaled antibiotic called Cayston to treat acute chest infections in people with CFAztreonam for inhalation for the treatment of acute exacerbations in cystic fibrosis. An open-label, randomised, cross-over pilot study of AZLI plus intravenous Colistin versus standard dual intravenous therapy. - AZTEC-CF Cystic fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Name: Cayston
INN or Proposed INN: Aztreonam
Other descriptive name: Cayston
Liverpool Heart & Chest HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 4United Kingdom
83NCT02613884
(ClinicalTrials.gov)
November 201620/11/2015Safety, Efficacy, and Feasibility of High-dose Cholecalciferol in Pediatric Patients With Cystic FibrosisSafety, Efficacy, and Feasibility of High-dose Cholecalciferol in Pediatric Patients With Cystic FibrosisVitamin D DeficiencyDrug: TreatmentJohns Hopkins All Children's HospitalNULLCompleted36 Months18 YearsAll30Phase 2United States
84EUCTR2016-001785-29-IE
(EUCTR)
15/08/201610/05/2016Study of the effects of combined treatment with the CFTR corrector ivacaftor and IV antibiotics on infection in CF.Combined Effect of CFTR Modifiers and Intensive Antibiotic Treatment Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Kalydeco
INN or Proposed INN: IVACAFTOR
Trade Name: Ciprofloxacin
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE
Product Name: Flucloxicillin
INN or Proposed INN: FLUCLOXACILLIN SODIUM
Trade Name: Fortum
INN or Proposed INN: CEFTAZIDIME
Product Name: Tobramycin
INN or Proposed INN: TOBRAMYCIN SULFATE
Trade Name: Meropenem
INN or Proposed INN: Meropenem
Other descriptive name: MEROPENEM
Trade Name: Colistin
INN or Proposed INN: COLISTIMETHATE SODIUM
St. Vincent's University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Ireland
85NCT02823470
(ClinicalTrials.gov)
June 20161/7/2016A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del CFTR MutationA Phase 4, Open-label Treatment, Randomized, Multicenter, 2-arm, Parallel-group, Pilot Study of Adherence to Lumacaftor/Ivacaftor in CF Subjects Homozygous for the F508del CFTR MutationCystic FibrosisDrug: LUM/IVA;Device: activated smart device;Device: de-activated smart deviceVertex Pharmaceuticals IncorporatedNULLTerminated16 YearsN/AAll24Phase 4United States;Canada
86NCT02781610
(ClinicalTrials.gov)
June 201612/5/2016Standardized Treatment of Pulmonary Exacerbations IIStandardized Treatment of Pulmonary Exacerbations II (STOP2)Pulmonary Cystic FibrosisDrug: Standard of care IV antibiotic(s)Chris GossCystic Fibrosis Foundation;CF Therapeutics Development Network Coordinating Center;Medical University of South Carolina;University of WashingtonCompleted18 YearsN/AAll1048Phase 4United States;Canada
87EUCTR2015-001644-11-DE
(EUCTR)
25/05/201631/03/2016Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
256Phase 3United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
88EUCTR2015-003881-96-IT
(EUCTR)
17/05/201605/11/2020Clinical study to assess two different Pseudomonas aeruginosa eradication protocols in patients with cystic ¿brosisPseudomonas aeruginosa eradication in patients with cystic fibrosis: a randomised multicentre study comparing classic treatment protocols with classic treatment together with antibiotic treatment of upper airways. - Clinical study to assess two different Pseudomonas aeruginosa eradication protocols in patients with cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: COLIMICINA - 1000000 U/4 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE1 FLACONCINO POLVERE + 1 FIALA SOLVENTE 4 ML
Product Name: NA
Product Code: [NA]
INN or Proposed INN: COLISTIMETATO SODICO
Other descriptive name: COLISTIN
AZIENDA OSPEDALIERO-UNIVERSITARIA MEYERNULLNot RecruitingFemale: yes
Male: yes
112Phase 3Italy
89EUCTR2016-000354-35-DK
(EUCTR)
12/05/201610/02/2016High dose antioxidant treatment of patients with cystic fibrosis evaluated by measuring desmosine/isodesmosine in urineHigh dose antioxidant treatment of patients with cystic fibrosis evaluated by measuring desmosine/isodesmosine in urine cystic fibrosis
MedDRA version: 19.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Mucolysin
INN or Proposed INN: ACETYLCYSTEINE SODIUM
Trade Name: AAC Hexal
INN or Proposed INN: ACETYLCYSTEINE SODIUM
Aarhus University HospitalNULLNot RecruitingFemale: yes
Male: yes
Phase 2Denmark
90EUCTR2015-001644-11-BE
(EUCTR)
06/04/201608/01/2016Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
256Phase 3United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
91EUCTR2015-001644-11-FR
(EUCTR)
16/03/201620/04/2016Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
256Phase 3United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
92EUCTR2015-001644-11-DK
(EUCTR)
15/03/201608/02/2016Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
256Phase 3United States;France;Canada;Belgium;Australia;Denmark;Germany;United Kingdom;Sweden
93EUCTR2014-004827-29-DE
(EUCTR)
24/02/201621/09/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
1375 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
94NCT03512119
(ClinicalTrials.gov)
February 11, 201615/1/2018Observational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-IvacaftorObservational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-IvacaftorCystic Fibrosis Homozygous for Phe 508 Del CFTR;Glucose Intolerance or Newly Diagnosis DiabetesDrug: Lumacaftor-Ivacaftor treatmentUniversity Hospital, Strasbourg, FranceNULLCompleted12 YearsN/AAll55France
95EUCTR2015-001644-11-GB
(EUCTR)
22/01/201610/11/2015Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
256Phase 3United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
96EUCTR2014-004827-29-ES
(EUCTR)
12/01/201618/11/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1375Phase 3United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
97EUCTR2014-004827-29-SE
(EUCTR)
09/12/201527/08/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1375Phase 3United States;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden
98NCT02626182
(ClinicalTrials.gov)
December 20153/12/2015Evaluation and Treatment of Pulmonary Vascular Disease in Moderate to Severe CFEvaluation and Treatment of Pulmonary Vascular Disease in Moderate to Severe Cystic Fibrosis Lung DiseaseCystic FibrosisDrug: sildenafil;Drug: placeboNational Jewish HealthNULLCompleted18 YearsN/AAll14Phase 1/Phase 2United States
99EUCTR2014-004827-29-DK
(EUCTR)
30/11/201511/09/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
1375 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Denmark;Australia;Netherlands;Germany;Sweden
100EUCTR2014-004827-29-AT
(EUCTR)
27/11/201527/08/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
1375 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
101EUCTR2015-003662-87-DK
(EUCTR)
13/11/201522/09/2015Pseudomonas Aeruginosa - Inhalation treatment, biomarkers and quality of lifePseudomonas Aeruginosa - Inhalation treatment, biomarkers and quality of life - Pseudomonas, Tazocin or Colistin Chronic pulmonary disease patients, except cystic fibrosis patients, with confirmed pulmonary infection by sputum sample positive for Pseudomonas Aeruginosa.
MedDRA version: 18.1;Level: LLT;Classification code 10051190;Term: Pneumonia Pseudomonas aeruginosa;System Organ Class: 100000004862
MedDRA version: 18.1;Classification code 10050700;Term: Chronic respiratory disease NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: colistimethate sodium (promixin)
INN or Proposed INN: COLISTIMETHATE SODIUM
Trade Name: Piperacillin with Tazobactam (tazocin)
INN or Proposed INN: PIPERACILLIN
Other descriptive name: PIPERACILLIN
INN or Proposed INN: TAZOBACTAM
Other descriptive name: TAZOBACTAM
Aarhus University Hospital, Department of Respiratory MedicineNULLNot RecruitingFemale: yes
Male: yes
Phase 2Denmark
102EUCTR2014-004827-29-NL
(EUCTR)
03/11/201521/09/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1375 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
103EUCTR2014-004827-29-GB
(EUCTR)
03/11/201505/08/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Symkevi
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1375Phase 3United States;United Kingdom;Switzerland;Spain;Canada;Austria;Netherlands;Sweden;Belgium;Ireland;Denmark;Italy;Israel;Australia;France;Germany
104EUCTR2014-004827-29-BE
(EUCTR)
21/10/201506/08/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1375Phase 3United States;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden
105EUCTR2014-004827-29-IE
(EUCTR)
19/10/201509/07/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
1375 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
106EUCTR2014-004827-29-IT
(EUCTR)
01/09/201508/07/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1375Phase 3United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
107NCT03497117
(ClinicalTrials.gov)
August 25, 201529/3/201819F MRI of Ventilation in Subjects With Cystic Fibrosis Undergoing Treatment for Pulmonary Exacerbation19F Magnetic Resonance Imaging of Ventilation in Subjects With Cystic Fibrosis Undergoing Treatment for Pulmonary ExacerbationCystic FibrosisDevice: Lung Clearance Index;Drug: MRI with PFPUniversity of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Terminated18 Years99 YearsAll5Early Phase 1United States
108NCT02544451
(ClinicalTrials.gov)
August 20151/9/2015Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With IvacaftorA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: LUM/IVAVertex Pharmaceuticals IncorporatedNULLCompleted6 YearsN/AAll246Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Sweden;United Kingdom
109NCT02531984
(ClinicalTrials.gov)
August 201521/8/2015The Efficacy of Azithromycin in Treating Children With Non Cystic Fibrosis BronchiectasisOpen Trial With Randomized Withdrawal of Treatment, to Evaluate the Efficacy of Azithromycin in the Treatment of Children With Non Cystic Fibrosis Bronchiectasis ( AZI-STOP Study )Non Cystic Fibrosis Bronchiectasis in ChildrenDrug: AzithromycinAssistance Publique Hopitaux De MarseilleNULLActive, not recruiting3 Years17 YearsBoth100Phase 3NULL
110NCT02565914
(ClinicalTrials.gov)
August 201518/9/2015A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis Who Have an F508del-CFTR MutationA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationCystic FibrosisDrug: TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll1044Phase 3United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Ireland;Israel;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom
111NCT02950883
(ClinicalTrials.gov)
March 24, 201527/10/2016Saline Hypertonic in Preschoolers + CTSaline Hypertonic in Preschoolers With Cystic Fibrosis and Lung Structure as Measured by Computed Tomography (CT)Cystic FibrosisDrug: Active Treatment Group 7% Hypertonic Saline;Drug: Control Group 0.9% Isotonic SalineUniversity of Washington, the Collaborative Health Studies Coordinating CenterCystic Fibrosis FoundationCompleted3 Years5 YearsAll116Phase 2/Phase 3United States;Australia;Belgium;Canada;Denmark;France;Italy;Netherlands;Spain
112NCT02325362
(ClinicalTrials.gov)
March 17, 201510/12/2014Effect of Miglustat on the Nasal Potential Difference in Patients With Cystic Fibrosis Homozygous for the F508del MutationSingle Center, Double-blind, Randomized, Placebo-controlled, Two-period/Two-treatment Crossover, Proof-of-mechanism Study Investigating the Effect of Miglustat on the Nasal Potential Difference in Adult Patients With Cystic Fibrosis Homozygous for the F508del MutationCystic FibrosisDrug: Miglustat ; placebo;Drug: Placebo ; MiglustatAssistance Publique - Hôpitaux de ParisActelion;CRCM (Centres de Ressources et de Compétences de la Mucoviscidose)Completed18 YearsN/AAll16Phase 2/Phase 3France
113ChiCTR-IPC-15005915
2015-01-312014-07-06A Randomized, Controlled Study of Combined the therapy of bronchoalveolar lavage and Amikacin injection in Patients with Acute Exacerbation of BronchiectasisA Randomized, Controlled Study of Combined the therapy of bronchoalveolar lavage and Amikacin injection in Patients with Acute Exacerbation of Bronchiectasis non-cystic fibrosis bronchiectasisExperimental group:Routine treatment combining with the therapy of bronchoalveolar lavage and local drug injection (Amikacin);Department of Respiratory Medicine, Shanghai Pulmonary Hospital, Tongji University School of MedicineNULLRecruiting1880BothExperimental group:50;NULL
114EUCTR2012-001565-33-IE
(EUCTR)
08/01/201511/09/2014An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistinAn open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosispatients
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 17.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Colistimethate
Other descriptive name: COLISTIMETHATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
67Phase 4Spain;Ireland;Germany;United Kingdom;Switzerland
115NCT02507843
(ClinicalTrials.gov)
January 201522/7/2015Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis BronchiectasisVitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis: a Double-blind Randomised Controlled TrialBronchiectasisDrug: Cholecalciferol;Drug: PlaceboShanghai Pulmonary Hospital, Shanghai, ChinaNULLRecruiting18 YearsN/ABoth200Phase 4China
116EUCTR2013-002202-31-DE
(EUCTR)
03/12/201408/10/2014Study conducted in several hospitals to verify the tolerance, safety and efficacy to cure of the study medication (POL7080) and its distribution in the body when given to patients with bronchiectasis caused by bacterium Pseudomonas aeruginosa,requiring intravenous treatment.A phase II, open-label, multi-center study to assess the tolerance, safety, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of POL7080 in the treatment of patients with acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection requiring intravenous treatment. - POL7080-002 Acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection.;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Product Name: POL7080
Product Code: POL7080
INN or Proposed INN: POL7080
Polyphor Ltd.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2Spain;Germany;United Kingdom
117NCT02273661
(ClinicalTrials.gov)
November 19, 201422/10/2014Evaluation of a Therapeutic Strategy Including Nebulised Liposomal Amphotericin B (Ambisome®) in Maintenance Treatment of Allergic Bronchopulmonary Aspergillosis (Cystic Fibrosis Excluded).Evaluation of a Therapeutic Strategy Including Nebulised Liposomal Amphotericin B (Ambisome®) in Maintenance Treatment of Allergic Bronchopulmonary Aspergillosis (Cystic Fibrosis Excluded)Allergic Bronchopulmonary AspergillosisDrug: Liposomal amphotericin B (Ambisome®);Drug: placeboPoitiers University HospitalNULLCompleted18 YearsN/AAll174Phase 2France
118NCT02194881
(ClinicalTrials.gov)
October 201417/7/2014Ivacaftor in French Patients With Cystic Fibrosis and a G551D MutationIvacaftor in French Patients With Cystic Fibrosis and a G551D Mutation - Efficacy and Safety Results After the First Year of Treatment in the Real Life Setting.Cystic FibrosisDrug: CF patients with a G551D mutation and treated with IvacaftorAssistance Publique - Hôpitaux de ParisVaincre la MucoviscidoseCompleted6 YearsN/AAll57N/AFrance
119NCT02372383
(ClinicalTrials.gov)
October 201420/6/2014Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic FibrosisPharmacokinetic Evaluation of Nontuberculous Mycobacterial Antibiotics in Cystic Fibrosis Versus ControlsCystic FibrosisDrug: Ethambutol;Drug: Rifampin;Drug: Azithromycin;Drug: PancrelipaseUniversity of Colorado, DenverCystic Fibrosis Foundation Therapeutics;Colorado Clinical & Translational Sciences InstituteCompleted16 Years45 YearsBoth32N/AUnited States
120EUCTR2014-000817-30-NL
(EUCTR)
14/08/201422/05/2014Comparing the effect of curcumin and genistein to treatment with Ivacaftor in CF patients with a class III mutationComparing the effect of curcumin and genistein to treatment with Ivacaftor in CF patients with a class III mutation - TICTAC-study Cystic Fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Ivacaftor/Kalydeco
Product Name: Curcuma Longa Extract cpl formaat 00 23,2 x 8,5 mm 723 mg
INN or Proposed INN: curcumin
Other descriptive name: CURCUMIN
Product Name: Genisteine Plus 150 mg cpl formaat 1 18,7 x 6,4 mm 438 mg
INN or Proposed INN: genistein
Other descriptive name: GENISTEIN
University Medical Centre UtrechtNULLNot RecruitingFemale: yes
Male: yes
Phase 2Netherlands
121NCT02054156
(ClinicalTrials.gov)
June 20141/2/2014OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic FibrosisOPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis: The OPTIMIZE Multicenter, Placebo-Controlled, Double-Blind, Randomized TrialCystic FibrosisDrug: azithromycin;Drug: placebo;Drug: Tobramycin solution for inhalationBonnie RamseyNational Heart, Lung, and Blood Institute (NHLBI)Completed6 Months18 YearsAll221Phase 3United States
122EUCTR2013-005481-19-DK
(EUCTR)
27/05/201427/05/2014High Dose Antioxidant Treatment for Patients with Cystic FibrosisHigh Dose Antioxidant Treatment for Patients with Cystic Fibrosis Cystic Fibrosis
MedDRA version: 17.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Mucolysin
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: ACETYLCYSTEINE
Trade Name: Mucomyst
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: ACETYLCYSTEINE
Trade Name: ACC
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: ACETYLCYSTEINE
Trade Name: Tad
INN or Proposed INN: GLUTATHIONE
Other descriptive name: GLUTATHIONE SODIUM
Aarhus University HospitalNULLNot RecruitingFemale: yes
Male: yes
Phase 2Denmark
123NCT02088216
(ClinicalTrials.gov)
April 1, 20145/3/2014Effect of Long-term, High-dose N-acetylcysteine on Exacerbations of BronchiectaisisEffect of N-acetylcysteine on Exacerbations of Bronchiectasis (BENE): a Randomized Controlled TrialNon-Cystic Fibrosis BronchiectasisDrug: N-acetylcysteine;Other: On-demand treatmentQilu Hospital of Shandong UniversityNULLCompleted18 Years80 YearsAll161N/AChina
124EUCTR2013-000604-41-DE
(EUCTR)
10/03/201420/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
125EUCTR2013-000604-41-NL
(EUCTR)
14/02/201426/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
126EUCTR2013-000604-41-IT
(EUCTR)
21/01/201414/08/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
127NCT02015663
(ClinicalTrials.gov)
January 201413/12/2013Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off CyclesA 24-week, Open-label, Parallel-group, Interventional Phase IV Study Comparing Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles for the Treatment of Pulmonary Pseudomonas Aeruginosa in Patients With Cystic FibrosisCystic FibrosisDrug: Tobramycin Inhalation PowderNovartis PharmaceuticalsNULLTerminated6 YearsN/AAll32Phase 4United States
128EUCTR2013-000604-41-CZ
(EUCTR)
18/12/201313/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
129EUCTR2013-000604-41-SE
(EUCTR)
10/12/201313/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
130EUCTR2013-000604-41-IE
(EUCTR)
09/12/201310/10/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
131EUCTR2013-000604-41-BE
(EUCTR)
04/12/201317/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
132EUCTR2009-016590-15-PL
(EUCTR)
03/12/201311/10/2013A clinical trial to assess the treatment with nebulised tobramycin in terms of safety and ability to kill Pseudomonas bacteria in the lungs of cystic fibrosis patients aged 3 months to 6 years includedA Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacyand Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P.aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. Lung colonisation with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Level: LLT;Classification code 10068292;Term: Pseudomonas colonization;System Organ Class: 100000004862
MedDRA version: 14.1;Classification code 10068297;Term: Pseudomonas colonisation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI 300 mg / 5 mL nebuliser solution
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
50United States;Greece;Russian Federation;Switzerland;Italy;France;Egypt;Hungary;Canada;Argentina;Poland;Romania;Germany
133EUCTR2013-000604-41-ES
(EUCTR)
03/12/201308/10/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
134NCT01946412
(ClinicalTrials.gov)
December 201316/9/2013Roll-Over Study of Ivacaftor in Cystic Fibrosis Pediatric Subjects With a CF Transmembrane Conductance Regulator Gene (CFTR) Gating MutationA Phase 3, 2-Arm, Roll-Over Study to Evaluate the Long-term Safety and Pharmacodynamics of Ivacaftor Treatment in Pediatric Subjects With Cystic Fibrosis and a CFTR Gating MutationCystic FibrosisDrug: IvacaftorVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsCompleted2 YearsN/AAll33Phase 3United States;Canada;United Kingdom
135NCT02096315
(ClinicalTrials.gov)
December 201318/3/2014Safety, Efficacy and PK/PD of POL7080 in Patients With Exacerbation of Non-cystic Fibrosis Bronchiectasis.A Phase II, Open-label, Multicenter Study to Assess the Tolerance, Safety, Efficacy and Pharmacokinetics/Pharmacodynamics (PK/PD) of POL7080 in the Treatment of Patients With Acute Exacerbation of Non-cystic Fibrosis Bronchiectasis Due to Pseudomonas Aeruginosa Infection Requiring Intravenous TreatmentBronchiectasis;Lower Respiratory InfectionDrug: POL7080Polyphor Ltd.NULLTerminated18 Years79 YearsAll20Phase 2Spain;United Kingdom
136EUCTR2013-000604-41-DK
(EUCTR)
19/11/201319/11/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Denmark;Australia;Netherlands;Germany;Sweden
137EUCTR2013-000604-41-AT
(EUCTR)
23/10/201316/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
138EUCTR2013-000604-41-GB
(EUCTR)
10/10/201317/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
139NCT01931839
(ClinicalTrials.gov)
October 201326/8/2013A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic FibrosisA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationCystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationDrug: Lumacaftor Plus Ivacaftor Combination;Drug: IvacaftorVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll1164Phase 3United States;Australia;Austria;Belgium;Canada;Czech Republic;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom
140EUCTR2013-002202-31-ES
(EUCTR)
24/09/201301/08/2013Study conducted in several hospitals to verify the tolerance, safety and efficacy to cure of the study medication (POL7080) and its distribution in the body when given to patients with bronchiectasis caused by bacterium Pseudomonas aeruginosa,requiring intravenous treatment.A phase II, open-label, multi-center study to assess the tolerance, safety, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of POL7080 in the treatment of patients with acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection requiring intravenous treatment. - POL7080-002 Acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection.;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Product Name: POL7080
Product Code: POL7080
INN or Proposed INN: POL7080
Other descriptive name: POL7080
Polyphor Ltd.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2Spain;Germany;United Kingdom
141EUCTR2013-002202-31-GB
(EUCTR)
11/09/201319/06/2013Study conducted in several hospitals to verify the tolerance, safety and efficacy to cure of the study medication (POL7080) and its distribution in the body when given to patients with bronchiectasis caused by bacterium Pseudomonas aeruginosa,requiring intravenous treatment.A phase II, open-label, multi-center study to assess the tolerance, safety, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of POL7080 in the treatment of patients with acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection requiring intravenous treatment. - POL7080-002 Acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection.;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Product Name: POL7080
Product Code: POL7080
INN or Proposed INN: POL7080
Other descriptive name: POL7080
Polyphor Ltd.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2Spain;Germany;United Kingdom
142NCT01844778
(ClinicalTrials.gov)
August 201329/4/2013Ease of Use and Microbial Contamination of Tobramycin Inhalation Powder (TIP) Versus Nebulised Tobramycin Inhalation Solution (TIS) and Nebulised Colistimethate (COLI)An Open-label, Crossover, Interventional Phase IV Study to Compare the Ease of Use of TIP With Nebulized TIS and Nebulized COLI for the Treatment of Pulmonary Pseudomonas Aeruginosa (P.a) in Patients With Cystic FibrosisCystic FibrosisDrug: Tobramycin Inhalation Powder;Drug: Tobramycin inhalation solution;Drug: ColistimethateNovartis PharmaceuticalsNULLCompleted6 YearsN/AAll60Phase 4Germany;Ireland;Spain;Switzerland;United Kingdom
143EUCTR2012-000386-20-GB
(EUCTR)
31/07/201326/04/2013A Roll-over study in children with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term safety and pharmacodynamics of ivacaftorA Phase 3, 2-Arm, Roll-Over Study to Evaluate the Long-term Safety and Pharmacodynamics of Ivacaftor Treatment in Pediatric Subjects With Cystic Fibrosis and a CFTR Gating Mutation cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
35 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;United Kingdom
144EUCTR2012-001565-33-ES
(EUCTR)
04/07/201316/05/2013An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistinAn open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosispatients
MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 16.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Trade Name: TOBI 300 mg/5 ml solución para inhalación por nebulizador
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Trade Name: Promixin,1 millón de Unidades Internacionales,polvo para solución para inhalación por nebulizador
INN or Proposed INN: Colistimethate
Other descriptive name: COLISTIMETHATE
Novartis Farmaceutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
67Phase 4Spain;Ireland;Germany;United Kingdom;Switzerland
145EUCTR2009-012842-21-HU
(EUCTR)
27/06/201310/05/2013Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic FibrosisRandomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Trade Name: Zenpep
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Aptalis Pharma US Inc.NULLNot RecruitingFemale: yes
Male: yes
86Hungary;Bulgaria;Germany;Italy;United Kingdom
146EUCTR2012-001565-33-GB
(EUCTR)
21/06/201316/04/2013An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistinAn open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 17.1;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Colistimethate
Other descriptive name: COLISTIMETHATE
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
67 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSpain;Ireland;Germany;Switzerland;United Kingdom
147EUCTR2012-001565-33-DE
(EUCTR)
05/06/201318/04/2013An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistinAn open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.1;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Colistimethate
Other descriptive name: COLISTIMETHATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
67Phase 4Spain;Ireland;Germany;United Kingdom;Switzerland
148NCT01746095
(ClinicalTrials.gov)
March 20136/12/2012Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis PatientsA Phase 2, Randomized, Double Blind, Placebo-controlled Study of AeroVanc for the Treatment of Persistent Methicillin-resistant Staphylococcus Aureus Lung Infection in Cystic Fibrosis PatientsCystic FibrosisDrug: Vancomycin hydrochloride inhalation powder;Drug: Placebo inhalation powderSavara Inc.Synteract, Inc.;Cystic Fibrosis FoundationCompleted12 YearsN/AAll87Phase 2United States
149NCT01707290
(ClinicalTrials.gov)
February 20139/10/2012Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non G551D CFTR MutationA Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long Term Ivacaftor Treatment in Subjects 6 Years of Age and Older With Cystic Fibrosis and a Non-G551D CFTR MutationCystic FibrosisDrug: IvacaftorVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsCompleted6 YearsN/AAll125Phase 3United States;Belgium;France;United Kingdom;Ireland
150NCT01695343
(ClinicalTrials.gov)
December 201225/9/2012Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic TreatmentA Phase 2, Randomized, Double-blind, Placebo-controlled, Repeat-dose Study of KB001-A in Subjects With Cystic Fibrosis Infected With Pseudomonas AeruginosaCystic FibrosisBiological: KB001-A;Drug: Placebo ComparatorKaloBios PharmaceuticalsNULLCompleted12 Years50 YearsBoth182Phase 2United States;Australia;Israel;New Zealand
151NCT01641822
(ClinicalTrials.gov)
December 201213/7/2012Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CFA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas Aeruginosa Infection in Subjects With Cystic FibrosisCystic FibrosisDrug: AZLI;Drug: Placebo to match AZLI;Drug: Tobramycin inhalation solutionGilead SciencesNULLCompleted6 YearsN/AAll107Phase 3United States
152EUCTR2009-012842-21-BE
(EUCTR)
19/11/201214/05/2012Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic FibrosisRandomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Trade Name: Zenpep
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREASLIPASE
Aptalis Pharma US Inc.NULLNot RecruitingFemale: yes
Male: yes
86Phase 3Hungary;Belgium;Bulgaria;Germany;Italy;United Kingdom
153NCT01684683
(ClinicalTrials.gov)
November 201211/9/2012The Effect of Theophylline in the Treatment of BronchiectasisClinical Efficacy and Safety of Theophylline in the Treatment of Non-Cystic Fibrosis(NCF) BronchiectasisBronchiectasisDrug: Theophylline;Drug: Placebo(for Theophylline)The First Affiliated Hospital of Guangzhou Medical UniversityNULLCompleted18 Years70 YearsBoth100Phase 4China
154NCT01721382
(ClinicalTrials.gov)
November 201226/10/2012Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic FibrosisTreatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis.Cystic FibrosisDrug: SitagliptinNemours Children's ClinicNULLCompleted13 Years20 YearsBoth6Phase 1United States
155EUCTR2012-000389-39-GB
(EUCTR)
25/10/201220/04/2012Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non-G551D CFTR MutationA Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long-Term Ivacaftor Treatment in Subjects 6 Years of Age and Older with Cystic Fibrosis and a Non-G551D CFTR Mutation cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Belgium;United Kingdom
156ChiCTR-TRC-12002470
2012-09-152012-08-02The effect of theophylline in the treatment of bronchiectasis, a random, double blind studyThe effect of theophylline in the treatment of bronchiectasis, a random, double blind study. bronchiectasis not due to cystic fibrosis1:theophylline;2:theophylline;The first affiliated hospital of Guangzhou Medical UniversityNULLCompleted1565Both1:46;2:46;China
157EUCTR2012-000389-39-BE
(EUCTR)
03/09/201226/04/2012Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non-G551D CFTR MutationA Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long-TermIvacaftor Treatment in Subjects 6 Years of Age and Older with CysticFibrosis and a Non-G551D CFTR Mutation Cystic Fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;United States;Belgium;United Kingdom
158NCT01667094
(ClinicalTrials.gov)
September 201213/8/2012A Study Comparing Continuous Infusion Antibiotics to Standard Treatment for Lung Infections in Cystic FibrosisContinuous-infusion Anti-pseudomonal ß-lactams for the Treatment of Acute, Infective Pulmonary Exacerbations in Cystic FibrosisCystic FibrosisDrug: Intermittent, short infusion Ceftazidime;Drug: Continuous infusion Ceftazidime;Drug: Intermittent, short infusion Meropenem;Drug: Continuous infusion Meropenem;Drug: Intermittent, short infusion Ticarcillin-clavulanate;Drug: Continuous infusion Ticarcillin-clavulanate;Drug: Intermittent, short infusion Cefepime;Drug: Continuous infusion Cefepime;Drug: Continuous infusion Piperacillin tazobactam;Drug: Intermittent, short infusion Piperacillin tazobactamThe AlfredNULLActive, not recruiting18 YearsN/AAll50Phase 4Australia
159NCT01694069
(ClinicalTrials.gov)
September 201219/9/2012Continuous Infusion Piperacillin-tazobactam for the Treatment of Cystic FibrosisContinuous Infusion Piperacillin-Tazobactam for the Treatment of Pulmonary Exacerbations in Patients With Cystic FibrosisCystic FibrosisDrug: Piperacillin-tazobactam combination productWest Virginia UniversityNULLTerminated8 YearsN/AAll6Phase 4United States
160EUCTR2011-005790-23-GB
(EUCTR)
17/07/201206/06/2012Comparison of recovery of adrenal gland function following short and long term steroid treatmentComparison of adrenal recovery following short and long-term glucocorticoid therapy. - Adrenal recovery following short and long-term glucocorticoid therapy Adrenal recovery following long and short term steroid treatment.
MedDRA version: 14.1;Level: LLT;Classification code 10066550;Term: Chronic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1;Classification code 10000842;Term: Acute lymphatic leukaemia;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1;Classification code 10008953;Term: Chronic liver disease;System Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: Hydrocortisone
INN or Proposed INN: Hydrocortisone
Birmingham Children's Hospital NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60United Kingdom
161NCT01641393
(ClinicalTrials.gov)
June 201210/7/2012Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in Cystic Fibrosis.A Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in the Treatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic FibrosisExocrine Pancreatic Insufficiency: Cystic FibrosisDrug: EUR-1008 25,000 Units;Drug: Kreon 25,000 UnitsAptalis PharmaNULLCompleted12 YearsN/ABoth96Phase 3Belgium;Bulgaria;France;Germany;Italy;Poland;United Kingdom
162EUCTR2011-001916-69-NL
(EUCTR)
22/05/201207/02/2012treatment with insulin in patients with cystic fibrosis without diabetesinsulin therapy in non-diabetic adults with cystic fibrosis - insulin in CF without CFRD cystic fibrosis patients without cystic fibrosis related diabetes;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Trade Name: Lantus 100 units/ml solution for injection in a cartridgeHagaZiekenhuis, pulmonary departmentNULLNot RecruitingFemale: yes
Male: yes
40Netherlands
163EUCTR2011-002719-27-IT
(EUCTR)
30/12/201113/03/2012EFFECT OF RECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-I ON GLUCOSE TOLERANCE AND AS PREVENTION TOWARDS THE DEVELOPMENT OF CYSTIC FIBROSIS RELATED DIABETES MELLITUSGLUCOSE METABOLISM AND INFLAMMATORY PARAMETERS UNDER IGF-I TREATMENT IN CYSTIC FIBROSIS - RH-IGF-I IN CYSTIC FIBROSIS PATIENTS WITH CYSTIC FIBROSIS
MedDRA version: 14.1;Level: PT;Classification code 10011766;Term: Cystic fibrosis pancreatic;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: INCRELEX*SC 1FL 4ML 10MG/ML
INN or Proposed INN: MECASERMIN
AZIENDA OSPEDALIERA DI PARMANULLNot RecruitingFemale: yes
Male: yes
20Italy
164EUCTR2011-006171-19-IT
(EUCTR)
27/10/201113/01/2012Multicentric and randomized study to evaluate the effectiveness of the association of the 2 different treatments in the early P.aerugionsa infection in patient with cystic fibrosis disease. The study will enlist pazients over 5 years old.randomized multicentric clinical trial upon efficacy of two different drugs combination to eradication of early p.aeruginosa infection in cystic fibrosis patients over 5 years old. Cystic fibrosis patients with early P.aeruginosa infection.
MedDRA version: 14.1;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: CIPROXIN*6CPR RIV 500MG
INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE
Trade Name: BRAMITOB*NEBUL 56F 300MG/4ML
INN or Proposed INN: TOBRAMYCIN
Trade Name: CIPROXIN*6CPR RIV 500MG
INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE
Trade Name: PROMIXIN*NEBUL 30MONOD 1MUI
INN or Proposed INN: COLISTIN MESILATE SODIUM
AZIENDA OSPEDALIERA MEYERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
165EUCTR2009-016590-15-IT
(EUCTR)
01/07/201114/03/2012Evaluation of the efficacy and safety of tobramycin for the treatment of early infections of P. aeruginosa in cystic fibrosis subjects aged from 3 months to less than 7 years.A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. Lung colonisation of Pseudomonas aeruginosa in cystic fibrosis patients.
MedDRA version: 14.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: TOBI*NEBUL 56F 1D 300MG/5ML
INN or Proposed INN: TOBRAMYCIN
Other descriptive name: NA
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
72France;Hungary;Greece;Canada;Poland;Russian Federation;Germany;Switzerland;Italy
166EUCTR2009-012842-21-BG
(EUCTR)
24/02/201128/09/2010Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic FibrosisRandomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Trade Name: Zenpep
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Aptalis Pharma US Inc.NULLNot RecruitingFemale: yes
Male: yes
86France;Hungary;Belgium;Spain;Poland;Ireland;Romania;Bulgaria;Germany;United Kingdom;Italy
167EUCTR2009-012842-21-DE
(EUCTR)
13/01/201113/07/2010Treatment of Exocrine Pancreatic Insufficiency in Subjects with Cystic FibrosisRandomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Aptalis Pharma US Inc.NULLNot RecruitingFemale: yes
Male: yes
86Hungary;Bulgaria;Germany;Italy;United Kingdom
168EUCTR2010-022042-24-GB
(EUCTR)
24/12/201025/10/2010A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis in patients with Pseudomonas Aeruginosa - RCT of Atorvastatin in Bronchiectasis in patients with PseudomonasA Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis in patients with Pseudomonas Aeruginosa - RCT of Atorvastatin in Bronchiectasis in patients with Pseudomonas The aim of this randomized double blind controlled study is to evaluate the efficacy of a 3 months treatment with atorvastatin versus placebo in patients with clinically significant bronchiectasis.
MedDRA version: 14.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Lipitor
Product Name: Atorvastatin
INN or Proposed INN: Atorvastatin
Other descriptive name: Lipitor
NHS LothianUniversity of EdinburghNot RecruitingFemale: yes
Male: yes
32Phase 4United Kingdom
169EUCTR2010-022040-20-GB
(EUCTR)
17/12/201021/10/2010A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis - Randomised Controlled Trial of Atorvastatin in BronchiectasisA Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis - Randomised Controlled Trial of Atorvastatin in Bronchiectasis The aim of this randomised double blind controlled study to evaluate the efficacy of 6 months treatment with atorvastatin versus placebo in patients with clinically significant bronchiectasis
MedDRA version: 14.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Lipitor
Product Name: Atorvastatin
INN or Proposed INN: Atorvastatin
Other descriptive name: Lipitor
NHS LothianUniversity of EdinburghNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
170EUCTR2009-012997-11-DE
(EUCTR)
27/09/201025/06/2010Study of long-term VX-770 treatment in Cystic Fibrosis subjects Age 6and OlderAn Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSIST Cystic Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
217France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
171EUCTR2009-012842-21-GB
(EUCTR)
20/09/201017/06/2010Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic Fibrosis Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Trade Name: Zenpep
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREASLIPASE
Aptalis Pharma US Inc.NULLNot Recruiting Female: yes
Male: yes
86 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noHungary;Belgium;Bulgaria;Germany;Italy;United Kingdom
172EUCTR2010-020516-11-IT
(EUCTR)
16/09/201028/09/2010EXPERIMENTAL STUDY, RANDOMIZED, OPEN LABEL, TO EVALUATE THE EFFECT OF DOCOSAHEXAENOIC ACID (DHA) SUPPLEMENTATION VERSUS 5-METHYLTETHRAHYDROFOLATE + B12 VITAMIN AND DHA, IN CYSTIC FIBROSIS PATIENTS AND PANCREATIC INSUFFICIENCY - NDEXPERIMENTAL STUDY, RANDOMIZED, OPEN LABEL, TO EVALUATE THE EFFECT OF DOCOSAHEXAENOIC ACID (DHA) SUPPLEMENTATION VERSUS 5-METHYLTETHRAHYDROFOLATE + B12 VITAMIN AND DHA, IN CYSTIC FIBROSIS PATIENTS AND PANCREATIC INSUFFICIENCY - ND CYSTIC FIBROSIS AND PANCREATIC INSUFFICIENCY
MedDRA version: 9.1;Level: PT;Classification code 10033628
MedDRA version: 9.1;Classification code 10011762
Trade Name: PREFOLIC*30CPR GASTROR 15MG
INN or Proposed INN: Detoxifying agents for antineoplastic treatment
Trade Name: INDUSIL*OS GTT FL 30MG+FL 15ML
INN or Proposed INN: Cobamamide
AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
173EUCTR2009-012842-21-IT
(EUCTR)
10/08/201023/08/2010A randomised, double blind, active-controlled, two-treatment, crossover multinational, multicentre trial to compare two pancreatic enzyme products in the treatment of exocrine pancreatic insufficiency in subjects with cystic fibrosis - NDA randomised, double blind, active-controlled, two-treatment, crossover multinational, multicentre trial to compare two pancreatic enzyme products in the treatment of exocrine pancreatic insufficiency in subjects with cystic fibrosis - ND exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF)
MedDRA version: 9.1;Level: HLGT;Classification code 10015674
MedDRA version: 9.1;Level: LLT;Classification code 10011762
Trade Name: ZENPEP
INN or Proposed INN: Multienzymes (lipase, protease etc.)
Trade Name: CREON 10000 Capsules
INN or Proposed INN: Multienzymes (lipase, protease etc.)
EURAND SPANULLNot RecruitingFemale: yes
Male: yes
86Hungary;Bulgaria;Germany;United Kingdom;Italy
174EUCTR2009-016590-15-DE
(EUCTR)
19/07/201015/04/2010A clinical trial to assess the treatment with nebulised tobramycin in terms of safety and ability to kill Pseudomonas bacteria in the lungs of cystic fibrosis patients aged 3 months to 6 years includedA Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacyand Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P.aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. Lung colonisation with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Level: LLT;Classification code 10068292;Term: Pseudomonas colonization;System Organ Class: 100000004862
MedDRA version: 14.1;Classification code 10068297;Term: Pseudomonas colonisation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI 300 mg/5 ml Lösung für einen Vernebler
Product Name: TOBI
Product Code: TBM100
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
50France;Egypt;Hungary;Greece;Canada;Argentina;Poland;Romania;Russian Federation;Germany;Switzerland;Italy
175EUCTR2008-005045-34-IE
(EUCTR)
09/07/201018/05/2010A double-blind, vehicle-controlled, multi-centre, clinical study to investigate the efficacy and safety of up to 6 months of therapy with inhaled Promixin in the treatment of patients with non-cystic fibrosis bronchiectasis infected with Pseudomonas aeruginosa susceptible to Promixin - Inhaled Promixin in the treatment of non-CF bronchiectasisA double-blind, vehicle-controlled, multi-centre, clinical study to investigate the efficacy and safety of up to 6 months of therapy with inhaled Promixin in the treatment of patients with non-cystic fibrosis bronchiectasis infected with Pseudomonas aeruginosa susceptible to Promixin - Inhaled Promixin in the treatment of non-CF bronchiectasis non-CF bronchiectasis (CF = cystic fibrosis)
MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis
Trade Name: Promixin 1 million International Units (IU) Powder for Nebuliser Solution
Other descriptive name: colistimethate sodium
Profile Pharma LtdNULLNot RecruitingFemale: yes
Male: yes
260United Kingdom;Ireland
176EUCTR2009-012997-11-GB
(EUCTR)
08/07/201021/06/2010 Study of long-term VX-770 treatment in Cystic Fibrosis subjects Age 6 and OlderAn Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSIST Cystic Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
217 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
177EUCTR2009-012997-11-IE
(EUCTR)
06/07/201005/05/2010Study of long-term VX-770 treatment in Cystic Fibrosis subjects Age 6and OlderAn Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSIST Cystic Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-770
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
217France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
178EUCTR2009-012997-11-CZ
(EUCTR)
22/06/201012/05/2010Study of long-term VX-770 treatment in Cystic Fibrosis subjects Age 6and OlderAn Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX-770 in Subjects with Cystic Fibrosis - PERSIST Cystic Fibrosis
MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
217France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
179EUCTR2009-016590-15-GR
(EUCTR)
15/06/201031/12/2009A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years.A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. Lung colonisation of Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 12.0;Level: LLT;Classification code 10068297;Term: Pseudomonas colonisation
MedDRA version: 12.0;Classification code 10068292;Term: Pseudomonas colonization
Trade Name: TOBI 300mg/5mL nebuliser solution
Product Name: TOBI
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
72France;Hungary;Greece;Poland;Germany;Italy
180NCT01149005
(ClinicalTrials.gov)
June 20109/6/2010Cystic Fibrosis (CF) Exacerbation and Insulin TreatmentEvaluation of Glucose Tolerance and Insulin Treatment in Non Diabetic Patients With Cystic Fibrosis During Acute Pulmonary ExacerbationCystic Fibrosis;Impaired Glucose Tolerance;Pulmonary ExacerbationDrug: novorapid / humalog short acting insulin;Drug: Novo Rapid Insulin (Novonordisk)Hadassah Medical OrganizationNULLNot yet recruiting10 YearsN/ABoth30N/AIsrael
181EUCTR2007-001401-15-DK
(EUCTR)
21/05/201014/04/2010Treatment of patients with cystic fibrosis with N-acetylcysteineTreatment of patients with cystic fibrosis with N-acetylcysteine Patients with cystic fibrosis and chronic Pseudomonas lung infection
MedDRA version: 12.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: ACC600Tabs
Product Name: N-acetylcystein
Product Code: R05C B01
INN or Proposed INN: ACETYLCYSTEINE
RigshospitaletNULLNot RecruitingFemale: yes
Male: yes
Phase 4Denmark
182NCT00967798
(ClinicalTrials.gov)
May 201027/8/2009Prevention of Cystic Fibrosis DiabetesA Randomized, Double-blind, Placebo-controlled Study to Determine Whether Chronic Treatment of Cystic Fibrosis Subjects With Impaired Glucose Tolerance Using Sitagliptin (Januvia) Prevents the Development of DiabetesCystic Fibrosis;PrediabetesDrug: SitagliptinEmory UniversityNULLTerminated13 YearsN/AAll33Phase 3United States;Canada
183EUCTR2009-016590-15-FR
(EUCTR)
15/04/201014/12/2009A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years.A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. Lung colonisation of Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 12.0;Level: LLT;Classification code 10068297;Term: Pseudomonas colonisation
MedDRA version: 12.0;Classification code 10068292;Term: Pseudomonas colonization
Trade Name: TOBI 300mg/5mL nebuliser solution
Product Name: TOBI
INN or Proposed INN: Tobramycin
Trade Name: TOBI 300mg/5mL nebuliser solution
Product Name: TOBI
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
72Phase 3France;Hungary;Greece;Poland;Germany;Italy
184NCT01460836
(ClinicalTrials.gov)
April 201025/10/2011Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic FibrosisIndirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic FibrosisCystic FibrosisDrug: Tobramycin solution for inhalation;Drug: Aztreonam lysine for inhalationNovartis PharmaceuticalsNULLCompleted6 YearsN/ABothN/ANULL
185NCT01082367
(ClinicalTrials.gov)
April 20105/3/2010Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 YearsA Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 YearsTreatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis PatientsDrug: TOBI;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted3 Months6 YearsAll50Phase 3Canada;Egypt;France;Germany;Greece;Hungary;Italy;Romania;Russian Federation;Switzerland;Poland;United States
186NCT01044719
(ClinicalTrials.gov)
January 201014/12/2009Duration of Antibiotics in Infective Exacerbations of Cystic FibrosisWhat Duration of Intravenous Antibiotic Therapy Should be Used in the Treatment of Infective Exacerbations of Cystic Fibrosis Chronically Colonised With Pseudomonas AeruginosaCystic FibrosisDrug: Ceftazidime;Drug: Tobramycin;Drug: MeropenemImperial College LondonNULLNot yet recruiting16 YearsN/ABoth240Phase 4United Kingdom
187EUCTR2009-016590-15-HU
(EUCTR)
29/12/200925/11/2009A clinical trial to assess the treatment with nebulised tobramycin in terms of safety and ability to kill Pseudomonas bacteria in the lungs of cystic fibrosis patients aged 3 months to 6 years includedA Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacyand Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P.aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. Lung colonisation with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Level: LLT;Classification code 10068292;Term: Pseudomonas colonization;System Organ Class: 100000004862
MedDRA version: 14.1;Classification code 10068297;Term: Pseudomonas colonisation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI 300 mg / 5 mL nebuliser solution
Product Name: TOBI
Product Code: TBM100
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
50France;Hungary;Greece;Canada;Poland;Russian Federation;Germany;Italy;Switzerland
188EUCTR2009-014042-28-GB
(EUCTR)
16/10/200914/10/2010What duration of intravenous antibiotic therapy should be used in the treatment of infective exacerbations of cystic fibrosis in patients chronically colonised with Pseudomonas aeruginosa? - Duration of antibiotics in infective exacerbations of cystic fibrosisWhat duration of intravenous antibiotic therapy should be used in the treatment of infective exacerbations of cystic fibrosis in patients chronically colonised with Pseudomonas aeruginosa? - Duration of antibiotics in infective exacerbations of cystic fibrosis Cystic FibrosisTrade Name: Meropenem
Product Name: Meropenem
INN or Proposed INN: Meropenem
Trade Name: Ceftazidime
Product Name: Ceftazidime
INN or Proposed INN: Ceftazidime
Trade Name: Tobramycin
Product Name: Tobramycin
INN or Proposed INN: Tobramycin
Imperial College, LondonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240United Kingdom
189EUCTR2008-003924-52-NL
(EUCTR)
06/10/200905/02/2009A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisA Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis Nonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: not assigned
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: not assigned
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: not assigned
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
PTC Therapeutics, IncNULLNot RecruitingFemale: yes
Male: yes
208Phase 3Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden
190EUCTR2006-006215-68-FR
(EUCTR)
21/09/200906/08/2009A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSAA MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA cystic fibrosis and P. aeruginosa chronic infection
MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal
MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Bramitob
Product Name: Tobrineb/Bramitob
INN or Proposed INN: tobramycin
Trade Name: Tobi 300mg/5ml Nebuliser solution.
Product Name: Tobi
INN or Proposed INN: tobramycin
Chiesi Farmaceutici S.p.ANULLNot RecruitingFemale: yes
Male: yes
320Phase 3France;Hungary;Czech Republic;Spain;Germany
191NCT00803205
(ClinicalTrials.gov)
September 8, 20094/12/2008Study of Ataluren (PTC124™) in Cystic FibrosisA Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisCystic FibrosisDrug: Ataluren;Drug: PlaceboPTC TherapeuticsCystic Fibrosis FoundationCompleted6 YearsN/AAll238Phase 3United States;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Spain;Sweden;United Kingdom
192NCT00989807
(ClinicalTrials.gov)
September 20092/10/2009Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic FibrosisExpanded Access for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease ProgressionCystic Fibrosis;Pseudomonas AeruginosaDrug: Aztreonam lysineGilead SciencesNULLApproved for marketing6 YearsN/ABothN/ACanada
193NCT00970346
(ClinicalTrials.gov)
September 20091/9/2009Safety and Efficacy of Inhaled OligoG CF-5/20 for the Treatment Cystic FibrosisA Randomised, Double-blind, Placebo-controlled Dose-escalation Phase I Study to Evaluate the Safety and Tolerability of Inhaled Aerosolised OligoG CF-5/20 (G-block Oligosaccharide Derived From Alginate Polysaccharide) in Healthy VolunteersCystic FibrosisDrug: OligoG CF-5/20AlgiPharma ASSmerud Medical Research International ASCompleted18 Years65 YearsMale26Phase 1United Kingdom
194NCT01111383
(ClinicalTrials.gov)
September 200913/4/2010A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®A Single Arm 48-Week Follow-on Safety Study to the Core Study (A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa)Cystic FibrosisDrug: tobramycinChiesi Farmaceutici S.p.A.NULLCompleted6 YearsN/AAll209Phase 3France;Poland;Ukraine
195EUCTR2008-003924-52-GB
(EUCTR)
26/08/200909/04/2009A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisA Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis Nonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: ataluren
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: ataluren
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: ataluren
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
PTC Therapeutics, IncNULLNot Recruiting Female: yes
Male: yes
208 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Spain;Belgium;Germany;Netherlands;Italy;United Kingdom;Sweden
196EUCTR2008-003924-52-DE
(EUCTR)
17/08/200910/07/2009A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisA Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis Nonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: ataluren
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: ataluren
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: ataluren
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
PTC Therapeutics, IncNULLNot RecruitingFemale: yes
Male: yes
208Phase 3France;Spain;Belgium;Netherlands;Germany;Italy;United Kingdom;Sweden
197EUCTR2008-003924-52-IT
(EUCTR)
26/06/200922/06/2009A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis - PTC124-GD-009-CFA Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis - PTC124-GD-009-CF Nonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 12.0;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: PTC124
Product Name: PTC124
Product Name: PTC124
PTC THERAPEUTICS, INC.NULLNot RecruitingFemale: yes
Male: yes
208Phase 3Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden
198EUCTR2008-003924-52-FR
(EUCTR)
12/06/200917/03/2009A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisA Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis Nonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: not assigned
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: not assigned
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: not assigned
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
PTC Therapeutics, IncNULLNot RecruitingFemale: yes
Male: yes
208Phase 3France;Spain;Belgium;Germany;Netherlands;Italy;United Kingdom;Sweden
199EUCTR2006-003275-12-NO
(EUCTR)
03/06/200927/03/2009Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin StudyScandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa.
MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Zitromax
Product Name: Zitromax
Product Code: Zitromax
INN or Proposed INN: AZITHROMYCIN
Trade Name: Zitromax
Product Name: zitromax
Product Code: zitromax
INN or Proposed INN: AZITHROMYCIN
Copenhagen CF-centreNULLNAFemale: yes
Male: yes
250Phase 4Denmark;Norway;Sweden
200EUCTR2008-003924-52-SE
(EUCTR)
08/04/200917/12/2008A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisA Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis Nonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: ataluren
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: ataluren
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: ataluren
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
PTC Therapeutics, IncNULLNot RecruitingFemale: yes
Male: yes
208Phase 3France;Spain;Belgium;Germany;Netherlands;Italy;United Kingdom;Sweden
201EUCTR2008-003924-52-BE
(EUCTR)
08/04/200920/02/2009Study of ataluren in patients with Cystic FibrosisA Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis Nonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, IncNULLNot RecruitingFemale: yes
Male: yes
208Phase 3France;United States;Canada;Spain;Belgium;Israel;Germany;Netherlands;Italy;United Kingdom;Sweden
202NCT00885365
(ClinicalTrials.gov)
April 200920/4/2009A Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas AeruginosaCystic FibrosisDrug: tobramycin / Bramitob;Drug: tobramycin / TOBIChiesi Farmaceutici S.p.A.NULLCompleted6 YearsN/AAll324Phase 3Czechia;France;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine;Czech Republic
203NCT01377792
(ClinicalTrials.gov)
March 20099/5/2011Study of Long-term Treatment With Hypertonic Saline in Patients With Cystic FibrosisPhase 4 Study of the Efficacy of Long-term Treatment With Hypertonic Saline on Pulmonary Exacerbations in Patients With Cystic FibrosisCystic FibrosisDrug: Hypertonic salineAdelaida Lamas FerreiroNULLCompleted6 YearsN/ABoth71Phase 4Spain
204EUCTR2008-005045-34-GB
(EUCTR)
15/12/200817/10/2008A clinical study to investigate the effect and safety of up to 6 months of treatment with inhaled Promixin in the treatment of chest infections causeed by Pseudomonas in people with a lung disease called bronchiectasisA double-blind, vehicle-controlled, multi-centre, clinical study to investigate the efficacy and safety of up to 6 months of therapy with inhaled Promixin in the treatment of patients with non-cystic fibrosis bronchiectasis infected with Pseudomonas aeruginosa susceptible to Promixin - Inhaled Promixin in the treatment of non-CF bronchiectasis non-CF bronchiectasis (CF = cystic fibrosis)
MedDRA version: 14.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin 1 million International Units (IU) Powder for Nebuliser Solution
Other descriptive name: colistimethate sodium
Profile Pharma LtdNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Ukraine;Ireland;Russian Federation;United Kingdom
205NCT00737100
(ClinicalTrials.gov)
September 200815/8/2008Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic FibrosisA Randomized, Double-blind, Placebo-controlled Parallel Group Study to Investigate the Safety and Efficacy of Two Doses of Tiotropium Bromide (2.5 mcg and 5 mcg) Administered Once Daily Via the Respimat Device for 12 Weeks in Patients With Cystic Fibrosis.Cystic FibrosisDrug: Placebo Respimat;Drug: Tiotropium bromide 5 mcg;Drug: tiotropium bromide-low dose-2.5mcgBoehringer IngelheimNULLCompletedN/AN/AAll510Phase 2United States;Australia;Belgium;France;Germany;Italy;Netherlands;New Zealand;Portugal;Russian Federation;United Kingdom
206EUCTR2007-004507-36-DE
(EUCTR)
19/08/200819/10/2007A multicenter, open label, 2 period cross-over study to evaluate the Pharmacokinetics of an 8 week continuous treatment with 1x300mg/d and 2x300mg/d TOBI® inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) Subjects.A multicenter, open label, 2 period cross-over study to evaluate the Pharmacokinetics of an 8 week continuous treatment with 1x300mg/d and 2x300mg/d TOBI® inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) Subjects. patients with cystic fibrosis and chronical infection with Pseudomonas aeruginosa
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Tobi
Product Name: Tobi
Product Code: TBM100
INN or Proposed INN: Tobramycin
Trade Name: Tobi
Product Name: Tobi
Product Code: TBM100
INN or Proposed INN: Tobramycin
Trade Name: Tobi
Product Name: Tobi
Product Code: TBM100
INN or Proposed INN: Tobramycin
Trade Name: Tobi
Product Name: Tobi
Product Code: TBM100
INN or Proposed INN: Tobramycin
Novartis Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
Germany
207EUCTR2006-006215-68-DE
(EUCTR)
14/08/200818/12/2008A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSAA MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA cystic fibrosis and P. aeruginosa chronic infection
MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal
MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Bramitob
Product Name: Tobrineb/Bramitob
INN or Proposed INN: tobramycin
Trade Name: Tobi 300mg/5ml Nebuliser solution.
Product Name: Tobi
INN or Proposed INN: tobramycin
Chiesi Farmaceutici S.p.ANULLNot RecruitingFemale: yes
Male: yes
320France;Hungary;Czech Republic;Spain;Germany
208EUCTR2006-006215-68-HU
(EUCTR)
13/08/200825/06/2008A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSAA MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA cystic fibrosis and P. aeruginosa chronic infection
MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal
MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Bramitob
Product Name: Tobrineb/Bramitob
INN or Proposed INN: tobramycin
Trade Name: Tobi 300mg/5ml Nebuliser solution.
Product Name: Tobi
INN or Proposed INN: tobramycin
Chiesi Farmaceutici S.p.ANULLNot RecruitingFemale: yes
Male: yes
320Hungary;Germany;Czech Republic;France;Spain
209EUCTR2008-002352-20-BE
(EUCTR)
11/08/200817/07/2008Single center, double-blind, randomized, placebo-controlled, two-period/two-treatment crossover study investigating the effect of miglustat on the nasal potential difference in patients with cystic fibrosis homozygous for the F508del mutationSingle center, double-blind, randomized, placebo-controlled, two-period/two-treatment crossover study investigating the effect of miglustat on the nasal potential difference in patients with cystic fibrosis homozygous for the F508del mutation Cystic fibrosis homozygous for the F508del mutation
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Zavesca
INN or Proposed INN: miglustat
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
Belgium
210NCT00742092
(ClinicalTrials.gov)
August 200826/8/2008Miglustat in Cystic FibrosisSingle Center, Double-blind, Randomized, Placebo-controlled, Two-period/Two-treatment Crossover Study Investigating the Effect of Miglustat on the Nasal Potential Difference in Patients With Cystic Fibrosis Homozygous for the F508del MutationCystic FibrosisDrug: miglustat;Drug: placeboActelionNULLCompleted12 YearsN/ABoth11Phase 2Belgium
211NCT00662675
(ClinicalTrials.gov)
August 200817/4/2008A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic InsufficiencyA Randomized Double-blind (Withdrawal) Phase 3 Study to Evaluate the Efficacy and Tolerability of Pancrelipase MT Capsules Compared With Placebo in the Treatment of Subjects With Cystic Fibrosis-dependent Exocrine Pancreatic InsufficiencyExocrine Pancreatic Insufficiency;Steatorrhea;Malabsorption Syndromes;Cystic FibrosisDrug: Pancrease MT 10.5, or MT 21;Drug: Placebo for Pancrease MT 10.5 or MT 21Johnson & Johnson Pharmaceutical Research & Development, L.L.C.NULLCompleted7 Years60 YearsAll40Phase 3United States;Canada
212EUCTR2006-006215-68-CZ
(EUCTR)
29/07/200816/06/2008A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSAA MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA cystic fibrosis and P. aeruginosa chronic infection
MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal
MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Bramitob
Product Name: Tobrineb/Bramitob
INN or Proposed INN: tobramycin
Trade Name: Tobi 300mg/5ml Nebuliser solution.
Product Name: Tobi
INN or Proposed INN: tobramycin
Chiesi Farmaceutici S.p.ANULLNot RecruitingFemale: yes
Male: yes
320Phase 3France;Hungary;Czech Republic;Spain;Germany
213NCT00411736
(ClinicalTrials.gov)
May 200814/12/2006Scandinavian Cystic Fibrosis Azithromycin StudySupplementary Oral Azithromycin in Treatment of Intermittent Pseudomonas Aeruginosa Colonization in CF-patients With Inhaled Colistin and Oral Ciprofloxacin; Postponing Next Isolate of Pseudomonas and Prevention of Chronic Infection. A Prospective, Double-blinded, Placebo-controlled Scandinavian Multi-centre Study.Cystic FibrosisDrug: Study medication, azithromycin or placebo;Drug: Azithromycin or placebo tabletsRigshospitalet, DenmarkCystic Fibrosis Foundation TherapeuticsCompleted1 YearN/ABoth45Phase 4Denmark;Norway;Sweden
214EUCTR2008-006502-42-IT
(EUCTR)
22/04/200807/04/2010Early antibiotic treatment in pseudomonas aeruginosa eradication in cystic fibrosis patients: a randomised policentric study on two different protocols - #FFC17/2007Early antibiotic treatment in pseudomonas aeruginosa eradication in cystic fibrosis patients: a randomised policentric study on two different protocols - #FFC17/2007 Cystic fibrosis
MedDRA version: 9.1;Level: SOC;Classification code 10038738
Trade Name: TOBI*NEBUL 56F 1D 300MG/5ML
INN or Proposed INN: Tobramycin
INN or Proposed INN: Colistin
INN or Proposed INN: Ciprofloxacin
AZIENDA OSPEDALIERA MEYERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
215EUCTR2007-003868-22-FR
(EUCTR)
19/03/200820/12/2007ASSESMENT OG EFFICACY AND TOLERABILITY OF INHABLED TOBRAMYCIN VS PLACEBO IN CYSTIC FIBROSIS PATIENTS REVEIVING ANTIBIOTHERAPY FOR 28 DAYS FOR PSEUDOMONAS AERUGINOSA PRIMO COLONISATION. - NEBCINAL 01-07ASSESMENT OG EFFICACY AND TOLERABILITY OF INHABLED TOBRAMYCIN VS PLACEBO IN CYSTIC FIBROSIS PATIENTS REVEIVING ANTIBIOTHERAPY FOR 28 DAYS FOR PSEUDOMONAS AERUGINOSA PRIMO COLONISATION. - NEBCINAL 01-07 Assessment of microbiological efficacy and tolerability of inhaled tobramycin vs placebo in cystic fibrosis patients, primo colonised by Pseudomonas aeruginosa justified inhaled antiobiotherapeutical treatment during 28 days. Product Code: NEB/01-07Laboratoire ErempharmaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
216NCT00762918
(ClinicalTrials.gov)
March 200826/9/2008Vitamin D3 for the Treatment of Low Vitamin D in Cystic FibrosisVitamin D and Its Non-Classic Roles in Cystic FibrosisCystic Fibrosis;Vitamin D DeficiencyDietary Supplement: cholecalciferolChildren's Hospital of PhiladelphiaNULLWithdrawn10 Years25 YearsBoth0Phase 3United States
217NCT00634192
(ClinicalTrials.gov)
February 20084/3/2008Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled TobramycinA Multicenter, Open Label, 2 Period Cross-over Study to Evaluate the PK of a 8 Week Continuous Treatment With 1x300mg/d and 2x300mg/d Tobramycin Inhaled With a 'Soft Mist' Nebulizer in Cystic Fibrosis (CF) SubjectsPseudomonas InfectionsDrug: tobramycinNovartisNULLCompleted6 YearsN/AAll50Phase 3Germany
218EUCTR2007-000171-41-IT
(EUCTR)
31/12/200707/01/2008A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - NDA Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - ND Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency.
MedDRA version: 9.1;Level: LLT;Classification code 10011766;Term: Cystic fibrosis pancreatic
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: Multienzymes (lipase, protease etc.)
Product Name: ALTUS-135
Product Code: ALTUS-135
INN or Proposed INN: Multienzymes (lipase, protease etc.)
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: Multienzymes (lipase, protease etc.)
ALTUS PHARMACEUTICALS INCNULLNot RecruitingFemale: yes
Male: yes
176Phase 3Italy
219EUCTR2007-000178-21-IT
(EUCTR)
31/12/200707/01/2008An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency. - NDAn Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency. - ND Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
MedDRA version: 9.1;Level: LLT;Classification code 10011766;Term: Cystic fibrosis pancreatic
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: Multienzymes (lipase, protease etc.)
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: Multienzymes (lipase, protease etc.)
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: Multienzymes (lipase, protease etc.)
ALTUS PHARMACEUTICALS INCNULLNot RecruitingFemale: yes
Male: yes
200Italy
220NCT00537602
(ClinicalTrials.gov)
November 200728/9/2007Miglustat / OGT 918 in the Treatment of Cystic FibrosisSingle Center, Double-blind, Randomized, Placebo-controlled, 2-period/2-treatment Crossover Study Investigating the Effect of Miglustat on the Nasal Potential Difference in Patients With Cystic Fibrosis Homozygous for the ?F508 MutationCystic FibrosisDrug: miglustat;Drug: placeboActelionNULLTerminated12 YearsN/ABoth6Phase 2Spain
221EUCTR2007-002912-24-DE
(EUCTR)
30/10/200705/09/2007Study to evaluate the safety and pharmacokinetics of ciprofloxacin following inhalation of ciprofloxacin dry powder for inhalation administered to pediatric patients with cystic fibrosis aged 12-17 yearsStudy to evaluate the safety and pharmacokinetics of ciprofloxacin following inhalation of ciprofloxacin dry powder for inhalation administered to pediatric patients with cystic fibrosis aged 12-17 years long term treatment of chronic lung infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis
MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Ciprofloxacin
Product Code: BAY q 3939
INN or Proposed INN: CIPROFLOXACIN
Other descriptive name: 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[1-piperazinyl]-3-quinoline carboxylic acid
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
16Germany
222NCT00528190
(ClinicalTrials.gov)
October 200710/9/2007Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic FibrosisTreatment of Aspergillus Fumigatus in Patients With Cystic Fibrosis: A Randomized, Double-blind, Placebo-Controlled TrialCystic FibrosisDrug: ItraconazoleOttawa Hospital Research InstituteThe Hospital for Sick Children;Canadian Cystic Fibrosis Foundation;The Physicians' Services Incorporated FoundationCompleted6 YearsN/AAll35Phase 4Canada
223EUCTR2007-000724-40-BE
(EUCTR)
27/09/200727/04/2007A Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisA Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Code: PTC124PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
30Phase 2Belgium
224EUCTR2007-000171-41-SK
(EUCTR)
16/07/200710/04/2008A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic InsufficiencyA Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
MedDRA version: 9.1;Level: LLT;Classification code 10011766;Term: Cystic fibrosis pancreatic
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: NA
Other descriptive name: Lipase CLEC
INN or Proposed INN: NA
Other descriptive name: Amylase
INN or Proposed INN: NA
Other descriptive name: Protease
Altus Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
176Phase 3Slovakia;Italy
225EUCTR2007-000178-21-SK
(EUCTR)
16/07/200710/04/2008An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic InsufficiencyAn Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
MedDRA version: 9.1;Level: LLT;Classification code 10011765;Term: Cystic fibrosis pancreas
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: NA
Other descriptive name: Lipase CLEC
INN or Proposed INN: NA
Other descriptive name: Amylase
INN or Proposed INN: NA
Other descriptive name: Protease
Altus Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3Slovakia;Italy
226NCT00506688
(ClinicalTrials.gov)
July 200724/7/2007Efficacy and Safety Study of Inhaled Glutathione in Cystic Fibrosis PatientsRandomized, Placebo-controlled, Double-blinded Study to Investigate the Efficacy and Safety of a 24-week Inhalation Treatment With Glutathione in Cystic Fibrosis PatientsCystic FibrosisDrug: reduced glutathione sodium salt;Drug: 0.9% normal saline (control)Mukoviszidose Institut gGmbHCystic Fibrosis Foundation TherapeuticsCompleted8 YearsN/ABoth153Phase 2Germany
227NCT00449904
(ClinicalTrials.gov)
June 200719/3/2007Open-Label Phase III Long-Term Safety Trial of LiprotamaseAn Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients With Cystic Fibrosis-Related Exocrine Pancreatic InsufficiencyCystic Fibrosis;Exocrine Pancreatic InsufficiencyDrug: LiprotamaseAnthera PharmaceuticalsNULLCompleted7 YearsN/ABoth214Phase 3United States
228EUCTR2006-003275-12-DK
(EUCTR)
23/05/200717/04/2007Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin StudyScandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa.
MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Zitromax
Product Name: zitromax
Product Code: zitromax
INN or Proposed INN: AZITHROMYCIN
Trade Name: Zitromax
Product Name: zitromax
Product Code: zitromax
INN or Proposed INN: AZITHROMYCIN
Copenhagen CF-centreNULLNot RecruitingFemale: yes
Male: yes
250Phase 4Denmark
229NCT00449878
(ClinicalTrials.gov)
May 200719/3/2007Liprotamase Efficacy Trial in Patients With Cystic Fibrosis-Related Exocrine Pancreatic InsufficiencyA Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients With Cystic Fibrosis-Related Exocrine Pancreatic InsufficiencyCystic Fibrosis;Exocrine Pancreatic InsufficiencyDrug: Liprotamase;Drug: PlaceboAnthera PharmaceuticalsNULLCompleted7 YearsN/ABoth163Phase 3United States
230NCT00458341
(ClinicalTrials.gov)
March 23, 20076/4/2007A Study of Ataluren in Pediatric Participants With Cystic FibrosisA Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisCystic FibrosisDrug: AtalurenPTC TherapeuticsNULLCompleted6 Years18 YearsAll30Phase 2Belgium;France;Israel
231EUCTR2006-005180-25-DE
(EUCTR)
15/12/200631/10/2006A study investigating the safety, tolerability and pharmacodynamics of bacterial lipase in patients with cystic fibrosis and pancreatic insufficiencyRandomized, double-blind, placebo-controlled, single period, parallel group designA study investigating the safety, tolerability and pharmacodynamics of bacterial lipase in patients with cystic fibrosis and pancreatic insufficiencyRandomized, double-blind, placebo-controlled, single period, parallel group design Caucasian males aged between 18 and 50 years of age (inclusive) with cystic fibrosis and pancreatic insufficiency able to discontinue their standard pancreatic enzyme therapy during the treatment phase of the study.
MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Code: LU 70274Nordmark Arzneimittel GmbHNULLNot RecruitingFemale: no
Male: yes
20Germany
232NCT00351078
(ClinicalTrials.gov)
December 200611/7/2006PTC124 for the Treatment of Cystic FibrosisA Phase 2b Extension Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisCystic FibrosisDrug: PTC124PTC TherapeuticsNULLCompleted18 YearsN/AAll19Phase 2Israel
233NCT00416182
(ClinicalTrials.gov)
December 200626/12/2006Nasally Delivered Pulmozyme for Sinusitis in Cystic FibrosisThe Use of Nasally Delivered Pulmozyme in the Treatment of Sinusitis in Cystic Fibrosis Patients: A Pilot StudySinusitis;Cystic FibrosisDrug: Pulmozyme (dornase alfa);Drug: PlaceboUniversity of VermontGenentech, Inc.Completed5 YearsN/AAll16Phase 2United States
234NCT00763412
(ClinicalTrials.gov)
November 200629/9/2008Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic FibrosisPilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic FibrosisCystic Fibrosis Related Diabetes;Pancreatic InsufficiencyDrug: placebo;Drug: repaglinideArbelaez, Ana MariaWashington University School of Medicine;National Institutes of Health (NIH);Novo Nordisk A/S;National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed12 Years24 YearsAll31N/AUnited States
235EUCTR2005-003870-88-DE
(EUCTR)
20/10/200628/08/2006Randomized, placebo-controlled, double-blind study to investigate the efficacy and safety of a 24-week inhalation treatment with glutathione in cystic fibrosis patients - GSH-4Randomized, placebo-controlled, double-blind study to investigate the efficacy and safety of a 24-week inhalation treatment with glutathione in cystic fibrosis patients - GSH-4 Cystic fibrosis (CF) is the most common autosomal recessive lethal hereditary disorder in Caucasians. The majority of cystic fibrosis patients die as a result of progressive pulmonary disease. Airway inflammation, characterized by an excessive and persistent neutrophilic infiltration, is key for the pathogenesis of CF lung disease, and ultimately leads to lung destruction.Product Name: GSH (Glutathione)
Product Code: TAD 600
INN or Proposed INN: Glutathione
Other descriptive name: reduced glutathione
Mukoviszidose Institut gGmbH i. G.NULLNot RecruitingFemale: yes
Male: yes
160Germany
236EUCTR2006-002259-33-DE
(EUCTR)
10/10/200611/07/2006Protocol for a Phase II-studyAnti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo - a randomised, double-blinded, placebo-controlled, cross over study -Protocol for a Phase II-studyAnti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo - a randomised, double-blinded, placebo-controlled, cross over study - CF-patients develop a chronic pulmonary infection with Pseudomonas aeruginosa (P. aeruginosa). At present it is unknown why CF-patients are highly sensitive to P. aeruginosa infections and, most important, no curative treatment for cystic fibrosis is available. This Study should provide a novel anti-inflammatory treatment for cystic fibrosis, which reduces pulmonary complications, progression of the disease and may possibly increase the life-expectance of the patients.Trade Name: Amitriptylin-ct Tabletten
Product Name: Amitriptyline
INN or Proposed INN: AMITRIPTYLINE
Trade Name: Amitriptylin-ct Tabletten
Product Name: Amitriptyline
INN or Proposed INN: AMITRIPTYLINE
Trade Name: Amitriptylin-ct Tabletten
Product Name: Amitriptyline
INN or Proposed INN: AMITRIPTYLINE
Paediatrisches Sekretariat fuer Klinische StudienNULLNot RecruitingFemale: yes
Male: yes
18Phase 2Germany
237NCT01463371
(ClinicalTrials.gov)
October 200628/10/2011Effects of Azithromycin on Airway Oxidative Stress Markers in Patients With BronchiectasisEffects of Long-Term Azithromycin Treatment on Airway Oxidative Stress Markers in Patients With Stable Non-Cystic Fibrosis BronchiectasisBronchiectasisDrug: AzithromycinInstituto de Investigacion Sanitaria La FeSociedad Valenciana de NeumologíaCompleted16 Years80 YearsBoth30N/ASpain
238EUCTR2005-002997-31-GB
(EUCTR)
10/08/200609/11/2005A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis. - Randomized trial of insulin detemir in CF associated pre-diabetesA multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis. - Randomized trial of insulin detemir in CF associated pre-diabetes Individuals with cystic fibrosis develop diabetes. They exhibit abnormal glucose handling (impaired glucose tolerance), poor growth and a decline in lung function before overt diabetes develops. Early treatment with insulin before diabetes develops may improve weight gain and lung function and delay progression to overt diabetes.Product Name: Levemir PenfillSheffield Children's NHS TrustNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
239NCT00297167
(ClinicalTrials.gov)
May 200627/2/2006Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic InsufficiencyA Randomized, Double-Blind, Placebo-Controlled, Two-Treatment, Crossover Study to Evaluate the Safety and Efficacy of Eurand Pancreatic Enzyme Product (PEP) in Patients With Cystic Fibrosis and Exocrine Pancreatic InsufficiencyCystic Fibrosis;Exocrine Pancreatic InsufficiencyDrug: EUR-1008 (APT-1008);Drug: PlaceboForest LaboratoriesNULLCompleted7 YearsN/AAll34Phase 3United States
240NCT00322868
(ClinicalTrials.gov)
April 20064/5/2006Safety and Efficacy of Pioglitazone as an Anti-inflammatory for the Treatment of Cystic Fibrosis (CF) Lung DiseaseA Pilot Study Assessing the Safety and Efficacy of Pioglitazone as an Anti-inflammatory Agent for the Treatment of CF Lung Disease in Patients With Cystic FibrosisCystic FibrosisDrug: pioglitazoneUniversity Hospitals Cleveland Medical CenterCystic Fibrosis FoundationCompleted18 YearsN/AAll21N/AUnited States
241NCT00308243
(ClinicalTrials.gov)
March 200627/3/2006Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis.Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis. A Phase I, Double Blind, Placebo Controlled, Safety Study. Stage 1)Cystic FibrosisDrug: Sodium Pyruvate in 0.9% Sodium Chloride SolutionEmphycorpCellular SciencesCompleted18 YearsN/ABoth15Phase 1United States
242NCT00332215
(ClinicalTrials.gov)
February 200630/5/2006A Phase I Study of Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis.Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis. A Phase I, Double Blind, Placebo Controlled, Safety Study.Cystic FibrosisDrug: Inhaled Sodium PyruvateUniversity of Minnesota - Clinical and Translational Science InstituteCellular SciencesTerminated18 YearsN/ABoth70Phase 1United States
243NCT00483769
(ClinicalTrials.gov)
February 20066/6/2007One Year Glargine Treatment in CFRD Children and AdolescentsOne-Year Glargine-Treatment Can Ameliorate Clinical Features in Cystic Fibrosis Children and Adolescents With Glucose DerangementsCystic Fibrosis;Glucose Metabolism DisordersDrug: GlargineFederico II UniversityNULLCompleted3 Years20 YearsBoth20Phase 4Italy
244NCT00237380
(ClinicalTrials.gov)
November 30, 20057/10/2005Safety and Efficacy of Ataluren (PTC124) for Cystic FibrosisA Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisCystic FibrosisDrug: AtalurenPTC TherapeuticsNULLCompleted18 YearsN/AAll24Phase 2Israel
245EUCTR2005-003837-42-GB
(EUCTR)
26/09/200524/08/2005CIPROFLOXACIN-INDUCED PHOTOTOXICITY IN PATIENTS WITH CYSTIC FIBROSIS - ciprofloxacin phototoxicity cystic fibrosisCIPROFLOXACIN-INDUCED PHOTOTOXICITY IN PATIENTS WITH CYSTIC FIBROSIS - ciprofloxacin phototoxicity cystic fibrosis infection - ciprofloxacin is used to treat various infections, for example respiratory tract infections, ear, nose and throat infections, eye infections, urinary tract infections. The main indication that is relevant to this application is its use in the treatment of chest infections in patients with cystic fibrosis. I have included the ICD classification for chest infection below.Trade Name: Ciprofloxacin (ciproxin)
Product Name: N/A
Product Code: N/A
Belfast City Hospital TrustNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
246NCT00234663
(ClinicalTrials.gov)
September 20055/10/2005PTC124 for Cystic FibrosisA Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisCystic FibrosisDrug: PTC124PTC TherapeuticsCystic Fibrosis Foundation Therapeutics;FDA Office of Orphan Products DevelopmentCompleted18 YearsN/ABoth24Phase 2United States
247NCT00217204
(ClinicalTrials.gov)
July 200513/9/2005An Effectiveness, Safety, and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat MalabsorptionA Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Effectiveness of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers With Cystic Fibrosis-Related Pancreatic Insufficiency and Fat MalabsorptionCystic Fibrosis;SteatorrheaDrug: Pancrelipase microtabletsMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.NULLCompleted6 Months30 MonthsBoth18Phase 2Belgium;Netherlands
248NCT00097773
(ClinicalTrials.gov)
September 200430/11/2004Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic FibrosisEffectiveness and Safety of Intermittent Antimicrobial Therapy for the Treatment of New Onset Pseudomonas Aeruginosa Airway Infection in Young Patients With Cystic FibrosisCystic Fibrosis;Pulmonary Disease, Chronic ObstructiveDrug: Tobramycin solution for inhalation (TOBI);Drug: Oral placebo;Drug: Oral ciprofloxacinSeattle Children's HospitalNational Heart, Lung, and Blood Institute (NHLBI);Cystic Fibrosis Foundation Therapeutics;CF Therapeutics Development Network Coordinating CenterCompleted1 Year12 YearsAll304Phase 2United States
249NCT00255242
(ClinicalTrials.gov)
July 200416/11/2005Effect of Simvastatin on CF Airway InflammationEffect of Simvastatin on CF Airway InflammationCystic FibrosisDrug: Simvastatin treatment for 28 daysAkron Children's HospitalCystic Fibrosis Foundation TherapeuticsCompleted10 YearsN/ABoth40Phase 1United States
250NCT00163852
(ClinicalTrials.gov)
February 200412/9/2005Treatment of Metabolic Alkalosis in Acute Exacerbations of Cystic FibrosisSalt Replacement for Metabolic Alkalosis in Acute Exacerbations of Cystic FibrosisCystic FibrosisDrug: Normal saline IV, salt tabletsBayside HealthNational Health and Medical Research Council, Australia;Monash University;Cystic Fibrosis AustraliaRecruiting18 Years75 YearsBoth40Phase 2/Phase 3Australia
251NCT00157690
(ClinicalTrials.gov)
December 20038/9/2005Study of Alendronate to Prevent and Treat Osteoporosis in Cystic Fibrosis PatientsA Multicentre, Double-Blind, Randomized Placebo-Controlled Study of 70mg Alendronate Once Weekly for the Prevention and Treatment of Osteoporosis in Canadian Adult Cystic Fibrosis PatientsCystic Fibrosis;Osteoporosis;Bone Diseases, MetabolicDrug: Alendronate;Drug: PlaceboMcMaster UniversityCentre hospitalier de l'Université de Montréal (CHUM);London Health Sciences Centre;University of Calgary;McGill University;Laval University;Merck Frosst Canada Ltd.Completed18 YearsN/ABoth56Phase 4Canada
252NCT00391976
(ClinicalTrials.gov)
November 200319/10/2006Efficacy and Safety of 28 or 56 Day Treatment for Pseudomonas Aeruginosa in Children With Cystic FibrosisThe Microbiologic Efficacy and Safety of Two Treatment Regimens of Inhaled Tobramycin Nebuliser Solution (TNS) for the Treatment of Early Onset Pseudomonas Aeruginosa Lower Respiratory Tract Infection in Subjects With Cystic FibrosisCystic FibrosisDrug: Tobramycin solution for inhalation 300 mgNovartisNULLCompleted6 MonthsN/AAll123Phase 3NULL
253NCT00499720
(ClinicalTrials.gov)
October 20039/7/2007Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway InfectionExpanded Access Program for Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease ProgressionCystic Fibrosis;Pseudomonas Aeruginosa Airway InfectionDrug: Aztreonam Lysine for InhalationGilead SciencesNULLApproved for marketing6 YearsN/ABothN/AUnited States;Puerto Rico
254NCT00079742
(ClinicalTrials.gov)
September 200311/3/2004A Study to Evaluate Nutropin AQ for the Treatment of Growth Restriction in Children With Cystic FibrosisA Phase II, Multicenter, Randomized, Controlled, Open-Label Study of the Safety and Efficacy of Nutropin AQ [Somatropin (DNA Origin) Injection] for the Treatment of Growth Restriction in Children With Cystic FibrosisCystic FibrosisDrug: Nutropin AQ [somatropin (DNA origin) injection]Genentech, Inc.NULLCompleted5 Years13 YearsBoth68Phase 2United States
255NCT00073463
(ClinicalTrials.gov)
June 200321/11/2003Safety and Efficacy of Recombinant Adeno-Associated Virus Containing the CFTR Gene in the Treatment of Cystic FibrosisA Multicenter, Double-Blind, Placebo Controlled, Phase II Study of Aerosolized tgAAVCF for the Treatment of Cystic FibrosisCystic FibrosisGenetic: tgAAVCFTargeted Genetics CorporationCystic Fibrosis Foundation TherapeuticsTerminated12 YearsN/ABoth100Phase 2/Phase 3United States
256NCT00060801
(ClinicalTrials.gov)
May 200313/5/2003Efficacy and Safety of 24 Weeks of Oral Treatment With BIIL 284 BS in Adult and Pediatric PatientsA Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of 24 Weeks of Oral Treatment With BIIL 284 BS in Adult (75 mg, 150 mg) and Pediatric (75 mg) Cystic Fibrosis PatientsCystic FibrosisDrug: BIIL 283 BS (Amelubent)Boehringer IngelheimNULLTerminated6 YearsN/ABoth420Phase 2United States
257NCT00376428
(ClinicalTrials.gov)
January 200313/9/2006Interest of Gentamicin-induced Readthrough in Cystic Fibrosis PatientsApplication of Functional Electrophysiological Tests to Evaluate Pharmacological Treatments in Patients With Cystic FibrosisCystic FibrosisDrug: GentamicinAssistance Publique - Hôpitaux de ParisNULLTerminatedN/AN/ABoth20Phase 2France
258NCT01812551
(ClinicalTrials.gov)
October 200214/3/2013Treatment of Low Bone Density in Cystic Fibrosis.Osteoporosis in Cystic Fibrosis: Study of Bone Mass and Bone Metabolism, and Prospective Randomized Therapeutic Trial.Osteoporosis;Cystic FibrosisDrug: Alendronate;Drug: PlaceboIstituto Auxologico ItalianoFondazione TelethonCompleted5 Years30 YearsBoth171Phase 3Holy See (Vatican City State);Italy
259NCT00043342
(ClinicalTrials.gov)
April 20027/8/2002Study of Interferon Gamma-1b by Injection for the Treatment of Patients With Cystic FibrosisA Phase I/II Study of Interferon Gamma-1b by Subcutaneous Injection for the Treatment of Patients With Cystic FibrosisCystic FibrosisDrug: interferon gamma-1bInterMuneNULLCompleted6 YearsN/ABoth51Phase 1/Phase 2United States
260NCT01400750
(ClinicalTrials.gov)
August 200118/7/2011Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic FibrosisProspective Randomized Trial Comparing Oral Ciproxin Plus Inhaled Colistin With Tobramycin for Inhalation for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis.Cystic FibrosisDrug: oral ciprofloxacin plus inhaled colistin;Drug: TOBIUniversitaire Ziekenhuizen LeuvenNULLCompletedN/A18 YearsBoth61Phase 4Belgium
261NCT00034515
(ClinicalTrials.gov)
June 200129/4/2002A Study in Adult and Pediatric Patients With Cystic FibrosisPh 1b/2a Study to Assess Levels of INS37217 and Placebo Treatment With Maximum Tolerated Dose Administered by Inhalation Via the Pari LC Star Nebulizer in Adult and Pediatric CF PatientsCystic FibrosisDrug: denufosol tetrasodium (INS37217) Inhalation SolutionMerck Sharp & Dohme Corp.NULLCompleted5 YearsN/ABoth63Phase 1/Phase 2United States
262NCT01882400
(ClinicalTrials.gov)
May 200117/6/2013Assessment of Response to Treatment of Osteoporosis With Oral Bisphosphonates in Patients With Muscular DystrophyÉvaluation Multidimensionnelle de la réponse au Traitement de l'ostéoporose spontanée et Induite Par Les corticostéroïdes à l'Aide d'un Bisphosphonate à Administration Orale Chez Des Malades Porteurs d'Une Dystrophie Musculaire sévère.Osteoporosis;Muscular Dystrophy;Cystic FibrosisDrug: Bisphosphonate treatmentGilles BoireProcter and GambleCompleted5 Years18 YearsAll11Phase 4Canada
263NCT00043316
(ClinicalTrials.gov)
February 20017/8/2002Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic FibrosisA Phase I/II Study of Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic FibrosisCystic FibrosisDrug: interferon gamma-1bInterMuneNULLCompleted12 YearsN/ABoth66Phase 1/Phase 2United States
264NCT00256555
(ClinicalTrials.gov)
February 200017/11/2005Growth Hormone Treatment Study in Children With Cystic FibrosisGROWTH HORMONE USE IN CYSTIC FIBROSIS - A MULTICENTER STUDYCystic FibrosisDrug: Nutropin AQUniversity of Texas Southwestern Medical CenterGenentech, Inc.Withdrawn5 Years12 YearsAll0Phase 2/Phase 3NULL
265NCT00004428
(ClinicalTrials.gov)
September 199718/10/1999Phase I Randomized Study of CPX for the Treatment of Adult Patients With Mild Cystic FibrosisCystic FibrosisDrug: CPXFDA Office of Orphan Products DevelopmentSciClone PharmaceuticalsCompleted18 YearsN/ABoth35Phase 1NULL
266EUCTR2020-001762-11-SE
(EUCTR)
17/07/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
267EUCTR2006-003275-12-SE
(EUCTR)
07/07/2009Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin StudyScandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa.
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Trade Name: Azithromycin
Product Name: azithromycin
Product Code: azithromycin
INN or Proposed INN: AZITHROMYCIN
Trade Name: Zitromax
Product Name: zitromax
Product Code: zitromax
INN or Proposed INN: AZITHROMYCIN
Copenhagen CF-centreNULLNAFemale: yes
Male: yes
250Phase 4Denmark;Norway;Sweden
268EUCTR2014-003023-22-FR
(EUCTR)
22/06/2015Open trial with randomized withdrawal of treatment, to evaluate the efficacy of azithromycin in the treatment of bronchiectasis excluding cystic fibrosis in children (AZI-STOP study)Open trial with randomized withdrawal of treatment, to evaluate the efficacy of azithromycin in the treatment of bronchiectasis excluding cystic fibrosis in children (AZI-STOP study) - AZI-STOP study bronchiectasis excluding cystic fibrosis in children;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: ZITHOMAX 40 mg/ml ENFANTS
Product Name: zithromax
INN or Proposed INN: AZITHROMYCIN DIHYDRATE
Trade Name: ZITHROMAX 250 mg
Product Name: ZITHROMAX
INN or Proposed INN: AZITHROMYCIN DIHYDRATE
ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLENULLNot RecruitingFemale: yes
Male: yes
100Phase 3France
269EUCTR2015-001997-16-DE
(EUCTR)
24/04/2017A study to assess the safety, pharmacokinetics, and pharmacodynamics of ivacaftor in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3, 2-Part, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have a CFTR Gating Mutation Cystic Fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
35 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;Ireland;Germany;United Kingdom
270EUCTR2005-001438-34-BE
(EUCTR)
15/07/2005A Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Efficacy of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers with Cystic Fibrosis-Related Pancreatic Insufficiency and Fat MalabsorptionA Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Efficacy of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers with Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption Cystic Fibrosis-Related Pancreatic Insufficiency and Fat MalabsorptionTrade Name: Panzytrat® ok
Product Name: Pancrelipase Microtablets
Product Code: N/A
INN or Proposed INN: Pancreatin
McNeil Consumer and Specialty PharmaceuticalsNULLNAFemale: yes
Male: yes
20Phase 2Belgium
271EUCTR2017-001379-21-IE
(EUCTR)
26/07/2017A study to assess the safety and pharmacodynamics of long-term ivacaftor treatment in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Kalydeco
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Kalydeco
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Kalydeco
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Kalydeco
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Kalydeco
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
75Phase 3Canada;United States;Ireland;United Kingdom;Germany
272EUCTR2015-000397-36-Outside-EU/EEA
(EUCTR)
03/02/2015Program to Give the Drug Aztreonamn Lysine for Inhalation to Canadian Patients with Cystic Fibrosis and infection by the Bacteria Pseudomonas aeruginosa Who Have Limited Treatment Options and are at Risk for Disease ProgressionExpanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients with Cystic Fibrosis and Pseudomonas aeruginosa Airway Infection Who Have Limited Treatment Options and are at Risk for Disease Progression Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNAFemale: yes
Male: yes
45Canada
273EUCTR2015-001997-16-GB
(EUCTR)
07/03/2016A study to assess the safety, pharmacokinetics, and pharmacodynamics of ivacaftor in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3, 2-Part, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Ivacaftor-responsive CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
35Phase 3United States;Canada;Ireland;Germany;United Kingdom
274EUCTR2020-001762-11-DE
(EUCTR)
17/09/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3Serbia;Portugal;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
275EUCTR2015-000396-26-Outside-EU/EEA
(EUCTR)
02/02/2015Program to Give the Drug Aztreonam Lysine for Inhalation to Patients with Cystic Fibrosis and infection by the Bacteria Pseudomonas aeruginosa Who Have Limited Treatment Options and are at Risk for Disease ProgressionExpanded Access Program for Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis and Pseudomonas aeruginosa Airway Infection Who Have Limited Treatment Options and are at Risk for Disease Progression Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Cayston
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNAFemale: yes
Male: yes
603United States
276EUCTR2007-000171-41-PL
(EUCTR)
11/07/2007A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic InsufficiencyA Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
MedDRA version: 9.1;Level: LLT;Classification code 10011766;Term: Cystic fibrosis pancreatic
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: NA
Other descriptive name: Lipase CLEC
INN or Proposed INN: NA
Other descriptive name: Amylase
INN or Proposed INN: NA
Other descriptive name: Protease
Altus Pharmaceuticals IncNULLNAFemale: yes
Male: yes
176Phase 3Slovakia;Poland;Italy
277EUCTR2015-001219-11-Outside-EU/EEA
(EUCTR)
31/03/2015A study of the efficacy and tolerability of pancrelipase microtablet (MT) capsules for the treatment of cystic fibrosis-dependent exocrine pancreatic insufficiencyA randomized double-blind (withdrawal) phase 3 study to evaluate the efficacy and tolerability of pancrelipase MT capsules compared with placebo in the treatment of subjects with cystic fibrosis-dependent exocrine pancreatic insufficiency Cystic fibrosis
MedDRA version: 17.1;Level: LLT;Classification code 10011765;Term: Cystic fibrosis pancreas;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: PANCREASE MT
Product Name: PANCREASE MT
INN or Proposed INN: pancrelipase
Other descriptive name: PANCRELIPASE AMYLASE
Johnson & Johnson Pharmaceutical Research and Development, L.L.C.NULLNAFemale: yes
Male: yes
40Phase 3United States;Canada
278EUCTR2015-001644-11-SE
(EUCTR)
05/11/2015Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
256Phase 3France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
279EUCTR2014-003882-10-FR
(EUCTR)
29/07/2015Evaluation of the efficacy of antibiotic treatments associated with the Nebcine® as intravenous injection only and / or monitoring of aerosols of Tobi® in order to optimize the therapeutic management of exacerbations in patients with cystic fibrosis .Evaluation of the effectiveness of a treatment involving one (or several ) antibiotic (s) with 14-day tobramycin ( Nebcine® ) by intravenous injection versus the same antibiotic treatment (s ) associated with only 5 days of tobramycin ( Nebcine® ) by intravenous injection followed tobramycin aerosol ( Tobi® ) for 9 days in the context of cystic fibrosis mucoviscidosis or cystic fibrosis
MedDRA version: 18.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: NEBCINE
Product Name: NEBCINE
Other descriptive name: TOBRAMYCIN
Trade Name: NEBCINE
Product Name: NEBCINE
Other descriptive name: TOBRAMYCIN
Trade Name: NEBCINE
Product Name: NEBCINE
Other descriptive name: TOBRAMYCIN
Trade Name: NEBCINE
Product Name: NEBCINE
Other descriptive name: TOBRAMYCIN
Trade Name: TOBI
Product Name: TOBI
Other descriptive name: TOBRAMYCIN
CHRU de LilleNULLNAFemale: yes
Male: yes
Phase 2France
280EUCTR2017-001379-21-DE
(EUCTR)
01/08/2017A study to assess the safety and pharmacodynamics of long-term ivacaftor treatment in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Kalydeco
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Kalydeco
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Kalydeco
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Kalydeco
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Kalydeco
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Kalydeco
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
75Phase 3Canada;United States;Ireland;United Kingdom;Germany
281EUCTR2015-000398-11-Outside-EU/EEA
(EUCTR)
03/02/2015A Clinical Trial to Assess the Safety and Efficacy of an Alternating Therapy of Antibiotics with the Drug Aztreonam for Inhalation Solution (AZLI) for the Treatment of Lung Infection by the bacteria Pseudomonas aeruginosa in Patients with Cystic Fibrosis.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas aeruginosa Infection in Subjects with Cystic Fibrosis Cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
INN or Proposed INN: AZTREONAM
Trade Name: TOBI®
INN or Proposed INN: TOBRAMYCIN
Other descriptive name: TOBRAMYCIN
Gilead Sciences, Inc.NULLNAFemale: yes
Male: yes
250Phase 3United States
282EUCTR2020-001762-11-AT
(EUCTR)
10/08/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance Study of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
283EUCTR2016-004318-82-Outside-EU/EEA
(EUCTR)
15/05/2017A study comparing Tobramycin Inhalation Powder (TIP) administered once daily continuously versus TIP administered BID in 28 day on / 28 day off cycles for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosisTobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: TOBI Podhaler
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Novartis Pharmaceuticals CorporationNULLNAFemale: yes
Male: yes
200Phase 4United States
284EUCTR2016-002749-42-IE
(EUCTR)
26/07/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 20.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
140 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands
285EUCTR2017-002968-40-DE
(EUCTR)
05/04/2018A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic FibrosisA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Symdeko
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Trade Name: Symkevi
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Trade Name: Symdeko
Product Name: Ivacaftor 75 mg
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor 150 mg
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
121Phase 3France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
286EUCTR2017-002968-40-FR
(EUCTR)
13/06/2018A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic FibrosisA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150mg
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
121Phase 3United States;France;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
287EUCTR2007-000178-21-PL
(EUCTR)
04/09/2007An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic InsufficiencyAn Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
MedDRA version: 9.1;Level: LLT;Classification code 10011765;Term: Cystic fibrosis pancreas
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: NA
Other descriptive name: Lipase CLEC
INN or Proposed INN: NA
Other descriptive name: Amylase
INN or Proposed INN: NA
Other descriptive name: Protease
Altus Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3Slovakia;Poland;Italy
288EUCTR2017-000571-85-PL
(EUCTR)
08/05/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
192Phase 3United States;Hungary;Spain;Poland;Lithuania;Israel;United Kingdom