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299. 嚢胞性線維症
［臨床試験数：1,592，薬物数：1,539（DrugBank：255），標的遺伝子数：81，標的パスウェイ数：162］

Searched query = "Cystic fibrosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
125 trials found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT04596319
(ClinicalTrials.gov)		December 202015/10/2020Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic FibrosisA Phase 1b/2a, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of AP-PA02 Multi-Phage Therapeutic Candidate for Inhalation in Subjects With Cystic Fibrosis and Chronic Pulmonary Pseudomonas Aeruginosa (Pa) InfectionCystic Fibrosis;Pseudomonas Aeruginosa;Pseudomonas;Lung Infection;Lung Infection PseudomonalBiological: AP-PA02;Other: PlaceboArmata Pharmaceuticals, Inc.Cystic Fibrosis FoundationRecruiting18 YearsN/AAll48Phase 1;Phase 2United States
2NCT04467957
(ClinicalTrials.gov)		October 1, 202019/6/2020Non-contrast Lung Perfusion Mapping Applied for New Insights in Cystic FibrosisNon-contrast Lung Perfusion Mapping Applied for New Insights in Cystic FibrosisCystic FibrosisDrug: Initiation of CFTR Modulator;Drug: Hyperpolarized Xenon 129Children's Hospital Medical Center, CincinnatiNULLNot yet recruiting6 Years21 YearsAll26Phase 4NULL
3NCT04058210
(ClinicalTrials.gov)		July 21, 202013/8/2019VX-445/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients Heterozygous for F508del Mutation and a Minimal Function Mutation (F/MF Genotypes)VX-445/TEZ/IVA Triple Combination Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function CFTR MutationCystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLApproved for marketing12 YearsN/AAllNULL
4NCT03988816
(ClinicalTrials.gov)		December 6, 201914/6/2019Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With BronchiectasisEffect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Non-cystic Fibrosis Bronchiectasis: a Cross-over, Unicentric, Double-blind and Placebo-controlled StudyBronchiectasis AdultDrug: Roflumilast;Drug: Placebo oral tabletUniversity of Sao Paulo General HospitalFAPESP - Fundação de Apoio à Pesquisa do Estado de São PauloRecruiting18 YearsN/AAll30Phase 2Brazil
5NCT02748798
(ClinicalTrials.gov)		May 201919/4/2016Developing Optimal Parameters for Hyperpolarized Noble Gas and Inert Fluorinated Gas MRI of Lung DisordersDeveloping Optimal Parameters for Hyperpolarized Noble Gas (3He and 129Xe) and Inert Fluorinated Gas Magnetic Resonance Imaging of Lung DisordersLung Transplant;Lung Resection;Lung Cancer;Asthma;Cystic Fibrosis;Chronic Obstructive Pulmonary Disease;Emphysema;Mesothelioma;Asbestosis;Pulmonary Embolism;Interstitial Lung Disease;Pulmonary Fibrosis;Bronchiectasis;Seasonal Allergies;Cold Virus;Lung Infection;Pulmonary Hypertension;Pulmonary Dysplasia;Obstructive Sleep ApneaDrug: HP 3He;Drug: HP 129Xe;Drug: PFP;Drug: SF6;Device: 129Xe Small and Large Human Lung Coil;Device: 3He Human Lung Coil;Device: PFP and SF6 Human Lung CoilThunder Bay Regional Research InstituteThunder Bay Regional Health Sciences Centre;St. Joseph's Care Group;Lakehead UniversityUnknown status18 YearsN/AAll160Early Phase 1Canada
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
6NCT03912233
(ClinicalTrials.gov)		April 30, 201910/4/2019A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic FibrosisCystic FibrosisDrug: VX-121;Drug: TEZ;Drug: VX-561;Drug: TEZ/IVA;Drug: IVA;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted18 YearsN/AAll87Phase 2United States;Germany;Netherlands;Portugal;United Kingdom
7NCT03911713
(ClinicalTrials.gov)		April 17, 20199/4/2019A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic FibrosisA Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic FibrosisCystic FibrosisDrug: VX-561;Drug: IVA;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted18 YearsN/AAll77Phase 2United States;Australia;Belgium;Germany;Ireland;Netherlands;United Kingdom
8NCT03795363
(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 IncorporatedRecruiting2 Years5 YearsAll32United States
9NCT03870841
(ClinicalTrials.gov)		April 3, 201924/10/2018The Effect of PC945 on Aspergillus Fumigatus Lung Infection in Patients With Cystic FibrosisAn Open-label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Inhaled PC945 in Adult Cystic Fibrosis (CF) Patients With Persistent Pulmonary Aspergillus Fumigatus InfectionAspergillosis;Cystic FibrosisDrug: PC945Pulmocide LtdNULLTerminated18 YearsN/AAll4Phase 2United Kingdom
10NCT03710538
(ClinicalTrials.gov)		April 1, 201920/6/2018The Effect of a Pre-meal Snack and/or Exercise on Post-prandial Glycemic Excursions in Adults With Cystic FibrosisThe Effect of a Pre-meal Snack and/or Exercise on Post-prandial Glycemic Excursions in Adults With Cystic FibrosisCystic FibrosisDietary Supplement: Snack beverage;Behavioral: ExerciseInstitut de Recherches Cliniques de MontrealNULLRecruiting18 YearsN/AAll14N/ACanada
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
11NCT03724955
(ClinicalTrials.gov)		April 201929/10/2018Pilot E2 for Hypogonadal Women With CFBDPilot Study Evaluating the Effects of Estradiol for Hypogonadal Women With Cystic Fibrosis and OsteopeniaCystic Fibrosis Related Bone DiseaseDrug: Estradiol 2 mg;Other: PlaceboEmory UniversityNULLWithdrawn18 YearsN/AFemale0Phase 4United States
12NCT03624101
(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: Tezacaftor/IvacaftorUniversity of Alabama at BirminghamNULLRecruiting18 YearsN/AAll5Phase 4United States
13NCT03265288
(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 FoundationRecruiting18 YearsN/AAll136Phase 2United States;Australia;Canada
14NCT03537651
(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;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting6 YearsN/AAll130Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Ireland;Poland;Switzerland;United Kingdom
15NCT03492567
(ClinicalTrials.gov)		April 25, 20183/4/2018Study of Circulating Blood Cell Monocytes as Predictive Biomarker of Bone Cystic Fibrosis Disease. Impact of CFTR Correctors.Study of Circulating Monocytes as Predictive Biomarker of Osteoclastogenesis in Cystic Fibrosis-related Bone Loss. Impact of CFTR Correctors.Cystic FibrosisBiological: Blood testAssistance Publique - Hôpitaux de ParisVaincre la MucoviscidoseCompleted18 YearsN/AAll25N/AFrance
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
16NCT03527095
(ClinicalTrials.gov)		April 5, 20184/5/2018A Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy SubjectsA Phase 1, Open-label, Randomised, Cross Over Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects Following Single DosesCystic FibrosisDrug: FDL169Flatley Discovery Lab LLCNULLCompleted18 Years55 YearsAll11Phase 1United Kingdom
17NCT03489629
(ClinicalTrials.gov)		April 3, 201829/3/2018STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)Cystic FibrosisDrug: Trimethoprim Sulfamethoxazole (TMP/SMX);Drug: Minocycline;Drug: Mupirocin;Drug: Chlorhexidine Gluconate;Behavioral: Environmental DecontaminationUniversity of North Carolina, Chapel HillUniversity of Washington;Cook Children's Medical Center;Indiana University;University of Michigan;University of Texas Southwestern Medical Center;St. Louis Children's HospitalRecruiting2 Years45 YearsAll42Phase 2United States
18EUCTR2017-002181-42-DE
(EUCTR)		27/10/201728/07/2017GLPG2737 on top of Orkambi in subjects with cystic fibrosisA Phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2737 in Orkambi-treated subjects with cystic fibrosis homozygous for the F508del 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: Body processes [G] - Genetic Phenomena [G05]		Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737		Galapagos NVNULLNot RecruitingFemale: yes
Male: yes		18Phase 2Germany
19NCT03278314
(ClinicalTrials.gov)		August 27, 20176/9/2017Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic FibrosisTezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic FibrosisCystic FibrosisDrug: tezacaftor/ivacaftorVertex Pharmaceuticals IncorporatedNULLApproved for marketing12 YearsN/AAllNULL
20NCT03277196
(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 IncorporatedNULLEnrolling by invitationN/A24 MonthsAll75Phase 3United States;Australia;Canada;Germany;Ireland;United Kingdom
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
21EUCTR2017-001379-21-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
22NCT02819856
(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
23EUCTR2016-004477-40-ES
(EUCTR)		31/05/201710/03/2017A study looking at the safety, tolerability and efficacy of the study drug GLPG2222 in patients with cystic fibrosis who have the F508del CFTR mutation on both allelesA Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del 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: Body processes [G] - Genetic Phenomena [G05]		Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222		Galapagos NVNULLNot RecruitingFemale: yes
Male: yes		50Phase 2Serbia;United States;Belgium;Spain;Netherlands;United Kingdom
24EUCTR2016-004477-40-BE
(EUCTR)		08/05/201721/02/2017A study looking at the safety, tolerability and efficacy of the study drug GLPG2222 in patients with cystic fibrosis who have the F508del CFTR mutation on both allelesA Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del 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: Body processes [G] - Genetic Phenomena [G05]		Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222		Galapagos NVNULLNot RecruitingFemale: yes
Male: yes		50Phase 2United States;Serbia;Spain;Belgium;Netherlands;United Kingdom
25NCT03051490
(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
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
26NCT03140527
(ClinicalTrials.gov)		April 10, 201727/4/2017Study Assessing the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic FibrosisA Multi-Center, Randomized, Placebo-Controlled, Phase 1, Two-Part Study Designed to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic FibrosisHealthy Volunteer;Cystic FibrosisDrug: PTI-801;Drug: Placebo;Drug: PTI-808Proteostasis Therapeutics, Inc.NULLCompleted18 YearsN/AAll171Phase 1United States;Canada;Denmark;Germany;Sweden;Portugal
27EUCTR2016-004477-40-NL
(EUCTR)		10/04/201714/02/2017A study looking at the safety, tolerability and efficacy of the study drug GLPG2222 in patients with cystic fibrosis who have the F508del CFTR mutation on both allelesA Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del 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: Body processes [G] - Genetic Phenomena [G05]		Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222		Galapagos NVNULLNot RecruitingFemale: yes
Male: yes		50Phase 2Serbia;United States;Belgium;Spain;Netherlands;United Kingdom
28NCT03104855
(ClinicalTrials.gov)		April 3, 201717/2/2017Clearance of 25-hydroxyvitamin D in Cystic FibrosisClearance of 25-hydroxyvitamin D in Cystic FibrosisCystic FibrosisDrug: d6-25-hydroxyvitamin D3University of WashingtonNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed18 YearsN/AAll10Phase 1United States
29EUCTR2016-002837-31-CZ
(EUCTR)		04/01/201724/10/2016A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutationA phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) 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: Body processes [G] - Genetic Phenomena [G05]		Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222		Galapagos NVNULLNot RecruitingFemale: yes
Male: yes		35Phase 2Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
30EUCTR2016-002837-31-DE
(EUCTR)		29/12/201624/10/2016A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutationA phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation - Albatross 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: Body processes [G] - Genetic Phenomena [G05]		Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222		Galapagos NVNULLNot RecruitingFemale: yes
Male: yes		35Phase 2Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
31EUCTR2016-002837-31-BE
(EUCTR)		16/12/201624/10/2016A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutationA phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) 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: Body processes [G] - Genetic Phenomena [G05]		Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222		Galapagos NVNULLNot RecruitingFemale: yes
Male: yes		35Phase 2Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
32EUCTR2016-002837-31-IE
(EUCTR)		02/12/201604/10/2016A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutationA phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) 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: Body processes [G] - Genetic Phenomena [G05]		Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222		Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		35Phase 2Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
33EUCTR2015-003291-77-DE
(EUCTR)		25/05/201611/11/2015A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutationA phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation Cystic fibrosis with the G551D mutation
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]		Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837		Galapagos NVNULLNot RecruitingFemale: yes
Male: yes		32Phase 2Czech Republic;Ireland;Australia;Germany;United Kingdom
34NCT02850692
(ClinicalTrials.gov)		April 18, 201616/6/2016Portal Hypertension and Systemic Endothelial FunctionPortal Hypertension and Systemic Endothelial Function: Investigation of Systemic Endothelial Dysfunction in Case of Portal Hypertension Associated With Cystic Fibrosis.Cystic Fibrosis;Portal HypertensionOther: measure of endothelial function;Biological: Blood sample;Other: Hepatic elastography;Diagnostic Test: Injected abdominal CTHopital FochNULLRecruiting18 YearsN/AAll60N/AFrance
35NCT02767297
(ClinicalTrials.gov)		April 20165/5/2016Bioavailability and Pharmacokinetics Study of FDL169 in Healthy Subjects and Subjects With Cystic FibrosisA Three-Part Phase 1b Bioavailability and Pharmacokinetics Study of Two Formulations of FDL169 in Healthy Subjects and Subjects With Cystic FibrosisCystic FibrosisDrug: FDL169Flatley Discovery Lab LLCNULLCompleted18 YearsN/ABoth46Phase 1;Phase 2United Kingdom
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
36NCT02724527
(ClinicalTrials.gov)		April 201611/3/2016Study of Cavosonstat (N91115) in CF Patients Who Are Heterozygous for F508del-CFTR and a Gating Mutation and Being Treated With IvacaftorA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of N91115 for Efficacy and Safety in Patients With CF Heterozygous for F508del-CFTR + Gating Mutation Being Treated With IvacaftorCystic FibrosisDrug: Cavosonstat;Drug: PlaceboNivalis Therapeutics, Inc.NULLActive, not recruiting18 YearsN/ABoth19Phase 2United States
37EUCTR2015-003292-30-NL
(EUCTR)		26/02/201602/12/2015A study looking at the safety of the drug GLPG1837 in patients with cysticfibrosis and the S1251N mutationA phase IIa, open-label study of two doses of GLPG1837 in subjects with cystic fibrosis and the S1251N mutation. Cystic fibrosis with the S1251N mutation
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]		Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837		Galapagos NVNULLNot RecruitingFemale: yes
Male: yes		6Phase 2Belgium;Netherlands
38EUCTR2015-003291-77-IE
(EUCTR)		03/02/201603/12/2015A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutationA phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation Cystic fibrosis with the G551D mutation
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]		Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837		Galapagos NVNULLNot RecruitingFemale: yes
Male: yes		32Phase 2Czech Republic;Ireland;Australia;Germany;United Kingdom
39NCT02840136
(ClinicalTrials.gov)		February 201618/7/2016LC-MS/MS Based Method Development for the Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis PatientsOptimisation, Valorisation and Application of UPLC-MS/MS Based Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis Patients - Part 3: Non-blank Sputum Samples for Method Optimisation and ValidationCystic FibrosisDrug: Piperacillin-tazobactam combination product;Drug: Meropenem;Drug: CeftazidimeUniversity GhentKing Baudouin Foundation;Belgische Vereniging voor Strijd tegen MucoviscidoseSuspended12 YearsN/AAll40N/ABelgium
40EUCTR2015-003291-77-CZ
(EUCTR)		26/01/201616/11/2015A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutationA phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation Cystic fibrosis with the G551D mutation
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]		Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837		Galapagos NVNULLNot RecruitingFemale: yes
Male: yes		32Phase 2Czech Republic;Ireland;Australia;Germany;United Kingdom
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
41EUCTR2015-003292-30-BE
(EUCTR)		18/01/201626/11/2015A study looking at the safety of the drug GLPG1837 in patients with cysticfibrosis and the S1251N mutationA phase IIa, open-label study of two doses of GLPG1837 in subjects with cystic fibrosis and the S1251N mutation. Cystic fibrosis with the S1251N mutation
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]		Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837		Galapagos NVNULLNot RecruitingFemale: yes
Male: yes		6Phase 2Belgium;Netherlands
42NCT02449031
(ClinicalTrials.gov)		May 5, 20154/5/2015Observational Study in Cystic Fibrosis Patients Using TOBI® Podhaler™ or Other FDA Approved Inhaled Antipseudomonal Antibacterial DrugsA Prospective Observational Study in Cystic Fibrosis Patients With Chronic Respiratory Pseudomonas Aeruginosa Infection Treated With TOBI® Podhaler™ (Tobramycin Inhalation Powder) or Other FDA Approved Inhaled Antipseudomonal Antibacterial DrugsPseudomonas Aeruginosa in Cystic FibrosisDrug: TOBI Podhaler;Drug: TOBI;Drug: Bethkis;Drug: CaystonMylan Inc.Cystic Fibrosis FoundationActive, not recruiting6 YearsN/AAll260United States
43NCT02690064
(ClinicalTrials.gov)		April 201519/2/2016Mechanisms for Vascular Dysfunction and Exercise Tolerance in CFMechanisms for Vascular Dysfunction and Exercise Tolerance in CFCystic FibrosisDietary Supplement: Acute Antioxidant;Dietary Supplement: Chronic Antioxidant;Other: PlaceboAugusta UniversityNULLRecruiting7 YearsN/AAll80N/AUnited States
44NCT02343445
(ClinicalTrials.gov)		April 201513/1/2015Clearing Lungs With Epithelial Sodium Channel (ENaC) Inhibition in Cystic Fibrosis (CF)A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of P-1037 Solution for Inhalation in Patients With Cystic Fibrosis (CF)Cystic FibrosisDrug: P-1037;Drug: Hypertonic Saline;Drug: SalineParion SciencesVertex Pharmaceuticals IncorporatedCompleted12 Years80 YearsAll142Phase 2United States
45NCT02445053
(ClinicalTrials.gov)		April 201511/5/2015Observational Study of Outcomes in Cystic Fibrosis Patients With Selected Gating Mutations on a CFTR Allele (The VOCAL Study)Observational Study of Outcomes in Cystic Fibrosis Patients With Selected Gating Mutations on a CFTR Allele (The VOCAL Study)Cystic FibrosisDrug: ivacaftorVertex Pharmaceuticals IncorporatedNULLCompleted6 YearsN/AAll75Italy;Netherlands;United Kingdom
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
46EUCTR2014-004519-35-GB
(EUCTR)		23/02/201508/12/2014A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic FibrosisA Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: CREON IR
INN or Proposed INN: NOT APPLICABLE
Other descriptive name: PANCREATIN (PAncreas Powder)
Trade Name: Kreon 25 000
Product Name: Creon® 25,000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN (Pancreas Powder)		Abbott Laboratories GmbHNULLNot RecruitingFemale: yes
Male: yes		78Phase 2Czech Republic;Hungary;Spain;United Kingdom
47EUCTR2014-004519-35-CZ
(EUCTR)		18/02/201519/11/2014A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic FibrosisA Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: CREON IR
INN or Proposed INN: NOT APPLICABLE
Other descriptive name: PANCREATIN (PAncreas Powder)
Trade Name: Kreon 25 000
Product Name: Creon® 25,000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN (Pancreas Powder)		Abbott Laboratories GmbHNULLNot RecruitingFemale: yes
Male: yes		78Phase 2Hungary;Czech Republic;Spain;United Kingdom
48EUCTR2014-004519-35-ES
(EUCTR)		30/01/201504/12/2014A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic FibrosisA Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: KREON de Liberación Inmediata
INN or Proposed INN: NOT APPLICABLE
Other descriptive name: PANCREATINA (Páncreas Polvo
Trade Name: Kreon 25 000
Product Name: Kreon® 25,000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATINA (Páncreas Polvo)		Abbott Laboratories GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		78Phase 2Czech Republic;Hungary;Spain;United Kingdom
49EUCTR2014-004519-35-HU
(EUCTR)		09/01/201512/11/2014A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic FibrosisA Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: CREON IR
INN or Proposed INN: NOT APPLICABLE
Other descriptive name: PANCREATIN (Pancreas Powder)
Trade Name: Kreon 25 000
Product Name: Creon® 25,000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN (Pancreas Powder)		Abbott Laboratories GmbHNULLNot RecruitingFemale: yes
Male: yes		78Phase 2Czech Republic;Hungary;Spain;United Kingdom
50NCT02178540
(ClinicalTrials.gov)		August 201424/6/2014Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis PatientsA Multi-center, Human Factors Engineering (HFE) Usability Study in Cystic Fibrosis Patients to Validate the Approved Instructions for Use (IFU) of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Using Placebo CapsulesCystic FibrosisDrug: Placebo;Device: Tobi PodhalerNovartis PharmaceuticalsNULLCompleted6 YearsN/AAll45Phase 4United States
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
51NCT02106832
(ClinicalTrials.gov)		April 30, 20144/4/2014Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.BronchiectasisDrug: Ciprofloxacin (BAYQ3939) dry powder for inhalation;Drug: PlaceboBayerNovartisCompleted18 YearsN/AAll521Phase 3United States;Argentina;Australia;Austria;Brazil;Bulgaria;China;Czechia;Germany;Hong Kong;Korea, Republic of;Latvia;Lithuania;Netherlands;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Taiwan;Thailand;Turkey;Czech Republic
52NCT02088216
(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
53NCT01991028
(ClinicalTrials.gov)		April 201418/11/2013A Study to Investigate Lung Deposition of Radiolabelled OligoGAn Open Label, Randomised, Two-way Crossover Scintigraphic Study to Investigate Lung Deposition of Radiolabelled OligoG Delivered as a Dry Powder and as a Nebulised Solution in Cystic Fibrosis PatientsCystic FibrosisDrug: Radiolabelled OligoG CF-5/20 DPI;Drug: Radiolabelled OligoG CF-5/20 6% SolutionBio-Images Research LtdAlgiPharma ASCompleted18 YearsN/ABoth10Phase 2United Kingdom
54NCT02141958
(ClinicalTrials.gov)		April 201413/5/2014Safety Study of Fenretinide in Adult Patients With Cystic FibrosisAn Adaptive Phase I Intra-patient Dose Escalation Study of Fenretinide in Adult Cystic Fibrosis PatientsCystic FibrosisDrug: Fenretinide;Drug: PlaceboElias MatoukNULLCompleted18 YearsN/ABoth15Phase 1Canada
55NCT02113397
(ClinicalTrials.gov)		April 20149/4/2014Evaluation of Inhaled Antibiotics on Bacterial Diversity and Richness in the Cystic Fibrosis LungComparative Evaluation of Bacterial Diversity and Richness in CF Lung in Patients Who Use Cycled Every Other Month Tobramycin Inhalation Powder (TOBI™ Podhaler™) Or Continuous Alternating Therapy With Tobramycin Inhalation Powder (TOBI™ Podhaler™) and Inhaled ColistimethateCystic FibrosisDrug: TOBI™ Podhaler™ 112 mg inhaled twice daily;Drug: Colistimethate 75 mg inhaled two times dailyDartmouth-Hitchcock Medical CenterNovartis PharmaceuticalsTerminated12 Years75 YearsAll1United States
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
56NCT01515007
(ClinicalTrials.gov)		April 201410/1/2012Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Subjects With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3)Non Cystic Fibrosis BronchiectasisDrug: Ciprofloxacin dispersion for inhalation;Drug: PlaceboAradigm CorporationGrifols Therapeutics LLCCompleted18 YearsN/AAll278Phase 3United States;Australia;Canada;Germany;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Poland;Romania;South Africa;Spain;Taiwan;United Kingdom;New Zealand
57NCT02057458
(ClinicalTrials.gov)		April 20144/2/2014Blood Flow and Vascular Function in Cystic FibrosisRole of Blood Flow and Vascular Function on Exercise Capacity in Cystic FibrosisCystic FibrosisDrug: Sildenafil (Acute-1 hour);Drug: Sildenafil (Subchronic-4 weeks);Drug: PlaceboAugusta UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed18 YearsN/AAll19Phase 2United States
58NCT02104245
(ClinicalTrials.gov)		April 201428/3/2014Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label ExtensionNon Cystic Fibrosis BronchiectasisDrug: Ciprofloxacin dispersion for inhalation;Drug: PlaceboAradigm CorporationGrifols Therapeutics LLCCompleted18 YearsN/AAll304Phase 3United States;Australia;Canada;Former Serbia and Montenegro;France;Georgia;Hungary;Israel;Italy;Korea, Republic of;New Zealand;Peru;Poland;Romania;Spain;United Kingdom;Germany
59NCT02084043
(ClinicalTrials.gov)		March 20148/3/2014In Vitro Assessment of a Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive VentilationIn Vitro Comparison of Continuous and Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation: Analysis of Inhaled and Lost Doses.Respiratory Diseases;Lung Diseases;Cystic Fibrosis;COPD;AsthmaDrug: Nebulization of Amikacin during NIV (RR: 15 cycles/minute);Drug: Nebulization of Amikacin during NIV (RR: 25 cycles/minute)University Hospital St Luc, BrusselsUniversité Catholique de Louvain;University of Applied Sciences of Western Switzerland;School of Gestion and Engineering Vaud, SwitzerlandCompletedN/AN/ABoth3N/ABelgium;Switzerland
60EUCTR2013-002819-10-ES
(EUCTR)		26/12/201312/11/2013A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ? 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic FibrosisA Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ? 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: KREON N 25000
INN or Proposed INN: Not applicable
Other descriptive name: PANCREATIN
Trade Name: Kreon 25000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATINA		Abbott Laboratories GmbHNULLNot RecruitingFemale: yes
Male: yes		40Hungary;Spain;Russian Federation
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
61EUCTR2013-002819-10-HU
(EUCTR)		29/11/201314/10/2013A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects = 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic FibrosisA Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects = 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: CREON N 25000
INN or Proposed INN: not applicable
Other descriptive name: PANCREATIN
Trade Name: Creon 25000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN		Abbott Laboratories GmbHNULLNot RecruitingFemale: yes
Male: yes		40Hungary;Spain;Russian Federation
62EUCTR2009-012842-21-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
63NCT01807949
(ClinicalTrials.gov)		April 20134/3/2013A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR MutationA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR MutationCystic Fibrosis, Homozygous for the F508del CFTR MutationDrug: Placebo;Drug: Lumacaftor Plus Ivacaftor Combination;Drug: IvacaftorVertex Pharmaceuticals IncorporatedNULLCompleted12 Years65 YearsAll563Phase 3United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Spain;United Kingdom
64NCT01818544
(ClinicalTrials.gov)		April 20138/3/2013Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (Cystic Fibrosis) BronchiectasisA Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY85-8501 in Patients With Non-Cystic Fibrosis BronchiectasisBronchiectasisDrug: BAY85-8501;Drug: PlaceboBayerNULLCompleted18 YearsN/ABoth94Phase 2France;Germany;Italy;Spain;United Kingdom
65EUCTR2009-012842-21-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
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
66NCT01641393
(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
67NCT01621867
(ClinicalTrials.gov)		May 201214/6/2012Repeated Application of Gene Therapy in CF PatientsA Randomised, Double-blind, Placebo-controlled Phase 2B Clinical Trial of Repeated Application of Gene Therapy in Patients With Cystic FibrosisCystic FibrosisDrug: pGM169/GL67A;Drug: PlaceboImperial College LondonUniversity of Edinburgh;University of Oxford;Royal Brompton & Harefield NHS Foundation TrustCompleted12 YearsN/ABoth130Phase 2United Kingdom
68NCT01270074
(ClinicalTrials.gov)		April 201223/12/2010Prevention of Bronchiectasis in Infants With Cystic FibrosisA Phase 3 Multi-centre Randomised Placebo-controlled Study of Azithromycin in the Primary Prevention of Radiologically-defined Bronchiectasis in Infants With Cystic Fibrosis.Cystic Fibrosis;BronchiectasisDrug: Azithromycin;Drug: Placebo controlThe University of QueenslandTelethon Kids InstituteActive, not recruiting6 Weeks6 MonthsAll132Phase 3Australia;New Zealand
69NCT01572194
(ClinicalTrials.gov)		April 201228/3/2012Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation (MUCO-IRC)Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation.Lung Transplantation;Cystic Fibrosis;Renal FailureBiological: Urinary levels of PIIINP as a marker of changes in renal functionNantes University HospitalNULLTerminated18 YearsN/AAll45N/AFrance
70EUCTR2011-004761-33-GB
(EUCTR)		08/03/201214/12/2011Repeated application of gene therapy in patients with cystic fibrosisA randomised double-blind placebo-controlled Phase 2B clinical trial of repeated application of gene therapy in patients with cystic fibrosis - Repeated application of gene therapy in patients with CF v01-010204 Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]		Imperial CollegeNULLNot Recruiting Female: yes
Male: yes		130Phase 2United Kingdom
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
71NCT01381289
(ClinicalTrials.gov)		June 201122/6/2011VX-770 Expanded Access ProgramVX-770 Expanded Access Program (EAP)Cystic FibrosisDrug: VX-770Vertex Pharmaceuticals IncorporatedNULLApproved for marketing6 YearsN/ABothN/ANULL
72NCT01347190
(ClinicalTrials.gov)		April 20113/5/2011Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic FibrosisA Double Blind, Randomized, Placebo Controlled, Single Dose, Phase I Study of the Safety and Tolerability of Alpha1 Proteinase Inhibitor (Human) Inhalation Solution (CR002) in Subjects With Cystic FibrosisCystic FibrosisBiological: CR002 Liquid API;Biological: PlaceboCSL BehringNULLCompleted18 Years65 YearsBoth25Phase 1Bulgaria;Hungary;Poland;United Kingdom
73NCT01314716
(ClinicalTrials.gov)		April 201111/3/2011Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis BronchiectasisA Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)BronchiectasisDrug: AZLI;Drug: PlaceboGilead SciencesNULLCompleted18 YearsN/AAll274Phase 3United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom
74NCT01327703
(ClinicalTrials.gov)		April 201128/3/2011Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic InsufficiencyAn Open-label, Multicenter, Randomized, Cross-over Study to Compare the Safety and Efficacy of PANZYTRAT® 25,000 to KREON® 25,000 in the Control of Steatorrhea in Subjects Aged 7 Years and Older With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)Exocrine Pancreatic Insufficiency;Cystic FibrosisDrug: Panzytrat® 25,000;Drug: Kreon® 25,000Forest LaboratoriesNULLCompleted7 YearsN/AAll87Phase 4Germany;Poland
75NCT01349192
(ClinicalTrials.gov)		April 20114/5/2011Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF)Early MRSA Therapy in CF - Culture Based vs. Observant Therapy (Treat or Observe) (Star-TOO - STaph Aureus Resistance - Treat or Observe)Cystic Fibrosis;Methicillin-resistant Staphylococcus AureusDrug: Rifampin;Drug: Trimethoprim/Sulfamethoxazole;Drug: Minocycline;Drug: Mupirocin;Drug: chlorhexidine gluconate oral rinse;Drug: 2% Chlorhexidine solution wipes;Behavioral: Environmental DecontaminationUniversity of North Carolina, Chapel HillCF Therapeutics Development Network Coordinating Center;Seattle Children's Hospital;Washington University School of Medicine;University of Washington;University of Colorado, Denver;Baylor College of Medicine;University of Alabama at Birmingham;Cook Children's Medical Center;University of Michigan;University of Florida;University of Texas Southwestern Medical Center;Children's Hospital Medical Center, Cincinnati;St. Louis Children's HospitalTerminated4 Years45 YearsAll47Phase 2United States
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
76NCT01313624
(ClinicalTrials.gov)		April 201110/3/2011Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis BronchiectasisA Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial InfectionBronchiectasisDrug: AZLI;Drug: PlaceboGilead SciencesNULLCompleted18 YearsN/AAll266Phase 3United States;Australia;Canada
77NCT01315665
(ClinicalTrials.gov)		April 201114/3/2011Effect of Sulforaphane in Broccoli Sprouts on Nrf2 ActivationEvaluation of the Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation, Measures of Oxidative Stress, and Neutrophil Migration to Mucosal Surfaces in Healthy and CF SubjectsCystic FibrosisDietary Supplement: Broccoli sproutsUniversity Hospitals Cleveland Medical CenterCystic Fibrosis FoundationCompleted18 Years49 YearsAll15N/AUnited States
78NCT01337219
(ClinicalTrials.gov)		April 201113/4/2011Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaid® in Patients With Cystic FibrosisPharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaide® in Patients With Cystic Fibrosis.Cystic FibrosisDrug: TobramycinErempharmaUniversity of Lyon;Epidemiologie Pharmacologie Investigation Clinique Information medicale Mere Enfant (EPICIME);Clininfo;Hospices Civils de LyonRecruiting16 YearsN/ABoth36Phase 1;Phase 2France
79EUCTR2009-012842-21-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
80EUCTR2009-012842-21-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
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
81EUCTR2009-012842-21-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]		Aptalis Pharma US Inc.NULLNot Recruiting Female: yes
Male: yes		86Phase 3Hungary;Belgium;Bulgaria;Germany;Italy;United Kingdom
82NCT01131507
(ClinicalTrials.gov)		July 201025/5/2010PR-018: An Open-Label, Safety Extension of Study PR-011A Multicenter, Open-Label, Safety Extension of Study PR-011 Titled: A Multicenter, Randomized, Open-Label, Crossover Study to Evaluate the Mode of Administration and Safety of EUR-1008 in Infants 1 to 12 Months of Age With Exocrine Pancreatic Insufficiency (EPI) Associated With Cystic Fibrosis (CF)Cystic Fibrosis;Exocrine Pancreatic InsufficiencyDrug: EUR-1008 (APT-1008)Forest LaboratoriesNULLCompletedN/A12 MonthsAll15Phase 4United States
83NCT01100606
(ClinicalTrials.gov)		June 201031/3/2010A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of AgeA Multicenter, Randomized, Open-Label, Crossover Study to Evaluate the Mode of Administration and Safety of EUR-1008 in Infants 1 to 12 Months of Age With Exocrine Pancreatic Insufficiency (EPI) Associated With Cystic Fibrosis (CF)Cystic Fibrosis;Exocrine Pancreatic InsufficiencyDrug: EUR-1008 (APT-1008)Forest LaboratoriesNULLCompleted1 Month12 MonthsAll15Phase 4United States
84NCT01321905
(ClinicalTrials.gov)		April 201023/3/2011Prospective Intervention Study on Vitamin D in Patients With Cystic Fibrosis5-month Pilot Intervention Study on Vitamin D in Patients With Cystic FibrosisCystic FibrosisDietary Supplement: Supplementation with vitamin D2/D3Karolinska InstitutetStockholm County Council, Sweden;Swedish Cystic Fibrosis AssociationRecruiting6 YearsN/ABoth15Phase 2Sweden
85NCT00763477
(ClinicalTrials.gov)		April 201030/9/2008Ghrelin in Cystic FibrosisThe Effect of Ghrelin on Appetite and Immune Function in Patients With Cystic FibrosisCystic FibrosisBiological: ghrelinPapworth HospitalNULLRecruiting18 Years80 YearsBoth20N/AUnited Kingdom
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
86NCT01460836
(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
87NCT01093521
(ClinicalTrials.gov)		April 201024/3/2010A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis PatientsA Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis PatientsCystic FibrosisDrug: 100 mg/m2 dose;Drug: 200 mg/m2 doseUniversity of WashingtonCystic Fibrosis FoundationCompleted18 Years55 YearsAll20Phase 1United States
88NCT01082367
(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
89NCT01499914
(ClinicalTrials.gov)		November 200921/11/2011Cohort Study Evaluating the Clinical Effectiveness, Safety and Immunogenicity to the Pandemic Influenza VaccinationCohort Study Evaluating the Clinical Effectiveness, Safety and Immunogenicity to the Pandemic Influenza Vaccination in Patients With Cystic Fibrosis and, Where Applicable, the Clinical Expression of Influenza A (H1N1)Cystic Fibrosis With Gastrointestinal ManifestationBiological: influenza vaccinationAssistance Publique - Hôpitaux de ParisNULLCompleted6 MonthsN/ABoth439Phase 4France
90NCT00989807
(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
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
91ChiCTR-TRC-13003979
2009-05-072013-10-28Application of roxithromycin in patients with bronchiectasis in stable conditionEffect of low-dose, long-term roxithromycin on airway imflammation and remodeling of stable non-cystic fibrosis bronchiectasis BronchietasisRoxithromycin group:The patients received oral roxithromycin in roxithromycin group;Control group:The patients received no drug in control group;First Affiliated Hospital of Guangxi Medical UniversityNULLCompleted1870BothRoxithromycin group:26;Control group:26;China
92NCT00709280
(ClinicalTrials.gov)		April 20091/7/2008Infant Study of Inhaled Saline in Cystic FibrosisInfant Study of Inhaled Saline in Cystic FibrosisCystic FibrosisDrug: 7% Hypertonic Saline (HS);Drug: 0.9% Isotonic Saline (IS)CF Therapeutics Development Network Coordinating CenterCystic Fibrosis Foundation Therapeutics;National Heart, Lung, and Blood Institute (NHLBI)Completed4 Months59 MonthsBoth321N/AUnited States;Canada
93NCT00880100
(ClinicalTrials.gov)		April 20099/4/2009Use of Ultrase® MT12 in Young Cystic Fibrosis Children (CF)Efficacy and Safety of Ultrase MT12 in the Control of Steatorrhea in Cystic Fibrosis (CF) and Pancreatic Insufficient (PI) Children Aged 2 to 6 Years OldCystic Fibrosis;Pancreatic InsufficiencyDrug: Ultrase® MT12Forest LaboratoriesNULLCompleted2 Years6 YearsAll49Phase 3United States
94NCT00885365
(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
95NCT00775528
(ClinicalTrials.gov)		April 200917/10/2008Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic FibrosisAn Open Label, Multi-center, Study to Assess the Safety and Tolerability of Pancrelipase Delayed Release Capsules in Infants and Children Less Than 7 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic FibrosisCystic Fibrosis;Pancreatic Exocrine InsufficiencyDrug: Pancrelipase Delayed ReleaseSolvay PharmaceuticalsNULLCompleted1 Month6 YearsAll19Phase 3United States
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
96NCT00840333
(ClinicalTrials.gov)		April 20095/2/2009Safety, Tolerability and Pharmacokinetics of MP-376 Administered for 14 Days to Stable Pediatric (CF) PatientsA Phase 1B, Multi-Center, Open Label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MP-376 Inhalation Solution Given Daily for 14 Days to Stable Pediatric Cystic Fibrosis Patients.Cystic FibrosisDrug: MP-376 (Levofloxacin solution for Inhalation)Horizon Pharma USA, Inc.NULLCompleted6 Years16 YearsAll27Phase 1United States
97NCT00843817
(ClinicalTrials.gov)		April 200912/2/2009RhDNase and Biodistribution of PMN Serine Proteases in Cystic Fibrosis SputumRhDNase Effect on Biodistribution of PMN Serine Proteases in Cystic Fibrosis SputumCystic FibrosisDrug: PulmozymeUniversity Hospital, ToursNULLCompleted18 YearsN/AAll15Phase 4France
98NCT01091025
(ClinicalTrials.gov)		March 200918/3/2010Comparing Two Different Approaches in the Screening of Cystic Fibrosis Related DiabetesA Comparative Analysis of the Clinical Efficacy of Two Approaches in the Screening for Cystic Fibrosis Related Diabetes in Adult With Cystic Fibrosis: i) a Selective Approach; ii) an Unselected Annual Oral Glucose Tolerance TestScreening of Cystic Fibrosis Related DiabetesOther: Glucose profile for 2 weeksImperial College LondonRoyal Brompton & Harefield NHS Foundation TrustCompleted16 YearsN/AAll100N/AUnited Kingdom
99NCT00476281
(ClinicalTrials.gov)		April 200818/5/2007Nutritional, Metabolic and Respiratory Status in Cystic FibrosisMulticenter Prospective Study of Abnormalies Tolerance Glucose by the Continuous Measurement of Glucose of Nutritional Status and Breathing in the Patient With Cystic FibrosisCystic Fibrosis;DiabetesProcedure: Urinary collect;Procedure: Continuous Glucose Monitoring System (CGMS)University Hospital, Strasbourg, FranceAssociation d'Aide aux Insuffisants Respiratoires d'Alsace LorraineCompleted10 YearsN/AAll114N/AFrance
100NCT00700050
(ClinicalTrials.gov)		April 200816/6/2008Modulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis AirwaysModulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis Airways - A Pilot StudyCystic FibrosisDrug: Hypertonic salineThe Hospital for Sick ChildrenNULLRecruitingN/A22 YearsBoth32Phase 3Canada
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
101NCT01323101
(ClinicalTrials.gov)		April 200815/2/2011Doxycycline Effects on Inflammation in Cystic FibrosisEffect of Doxycycline on Sputum Biomarkers of Inflammation and Lung Epithelial Repair in Patients With Cystic Fibrosis.Cystic FibrosisDrug: Doxycycline;Other: No doxycyclineUniversity of Southern CaliforniaNULLCompleted18 YearsN/AAll21Phase 4United States
102NCT01759342
(ClinicalTrials.gov)		April 200821/12/2012Comprehensive Exercise Training Program During Hospitalization for an Acute CF ExacerbationThe Efficacy of a Standardized Exercise Protocol in Inpatient Care of Patients With Cystic FibrosisCystic FibrosisBehavioral: Aerobic exercise;Behavioral: Resistance exercise;Behavioral: Flexibility and postural exercise;Behavioral: Balance exerciseUniversity of Alabama at BirminghamNULLCompleted6 Years21 YearsBoth23N/AUnited States
103EUCTR2006-001254-27-FR
(EUCTR)		30/11/200625/08/2006Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitusOpen randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus Patients atteints de mucoviscidose, chez lesquels un diagnostic de diabète a été fait par hyperglycémie provoquée orale (HGPO)
MedDRA version: 8.1;Level: PT;Classification code 10012594;Term: DIABETES		Trade Name: NovoNorm 0.5 mg
Product Name: NovoNorm 0.5 mg
INN or Proposed INN: Répaglinide
Trade Name: Actrapid Penfill 100UI/ml
Product Name: Actrapid Penfill 100UI/ml
INN or Proposed INN: Insuline humaine recombinante
Trade Name: NovoNorm 1 mg
Product Name: NovoNorm 1 mg
INN or Proposed INN: Répaglinide
Trade Name: NovoNorm 2 mg
Product Name: NovoNorm 2 mg
INN or Proposed INN: Répaglinide		ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		France
104NCT00572975
(ClinicalTrials.gov)		August 200611/12/2007Malabsorption Blood Test:Toward a Novel Approach to Quantify SteatorrheaMALABSORPTION BLOOD TEST: Toward a Novel Approach to Quantify SteatorrheaCystic Fibrosis;Pancreatic InsufficiencyOther: Pentadecanoic acid (PA) and Triheptadecanoin (THA)Children's Hospital of PhiladelphiaSolvay PharmaceuticalsCompleted8 YearsN/ABoth9Phase 4United States
105NCT00981214
(ClinicalTrials.gov)		May 200621/9/2009Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic InsufficiencyAn Open-Label Study to Evaluate the Efficacy and Safety of Pancreatic Enzyme Product (PEP) Microtabs in Pediatric Patients With Cystic Fibrosis and Exocrine Pancreatic InsufficiencyCystic Fibrosis;Exocrine Pancreatic InsufficiencyDrug: EUR-1008 (APT-1008)Forest LaboratoriesNULLCompletedN/A7 YearsAll19Phase 3United States
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
106NCT00297167
(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
107NCT00322868
(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
108NCT00420836
(ClinicalTrials.gov)		April 200610/1/2007Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic StudyCrossover Pharmacokinetic Study of Tobramycin Administered for Inhalation by PARI eFlow® Rapid Electronic Nebulizer (no Compressor) vs. PARI LC PLUSTM Jet Nebulizer (With Compressor) in Cystic Fibrosis SubjectsCystic FibrosisDrug: TobramycinNovartisNULLCompleted6 YearsN/ABoth20Phase 1NULL
109EUCTR2005-003837-42-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.Belfast City Hospital TrustNULLNot Recruiting Female: yes
Male: yes		60Phase 4United Kingdom
110NCT00219882
(ClinicalTrials.gov)		April 200516/9/2005Safety Study of Orally Administered Curcuminoids in Adult Subjects With Cystic FibrosisA Phase I Safety and Dose Finding Study of Orally Administered Curcuminoids in Adult Subjects With Cystic Fibrosis Who Are Homozygous for Delta F508 Cystic Fibrosis Transmembrane Conductance Regulator (?F508 CFTR) MutationCystic FibrosisDrug: standardized turmeric root extractRamsey, Bonnie, MDSeer Pharmaceuticals;CF Therapeutics Development Network Coordinating Center;Cystic Fibrosis Foundation TherapeuticsCompleted18 Years40 YearsBoth11Phase 1United States
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
111NCT00198289
(ClinicalTrials.gov)		April 20059/9/2005Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their LungsA Phase IIa Dose Escalation Study to Assess Safety and Pharmacokinetics of Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their LungsStaphylococcus AureusDrug: Aurexis® (tefibazumab)Bristol-Myers SquibbNULLCompleted7 YearsN/ABoth30Phase 2United States
112NCT00730509
(ClinicalTrials.gov)		April 20044/8/2008Effects of 5-Methyltetrahydrofolate and Vitamin B12 Supplemetation on Red Cell Membrane in Children With Cystic FibrosisPreliminary Evidences of Active Form of Folic Acid and Vitamin B12 Supplementation to Ameliorate Cell Membrane in Children With Cystic FibrosisCystic FibrosisDietary Supplement: 5-methyltetrahydrofolate and vitamin B12Universita di VeronaNULLCompleted3 Years8 YearsBoth31N/AItaly
113NCT00499720
(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
114NCT00222521
(ClinicalTrials.gov)		April 200314/9/2005Insulin Glargine Vs Standard Insulin TherapyComparison of Insulin Glargine Vs Standard Insulin Therapy in CFRD Without Fasting HyperglycemiaCystic Fibrosis Related DiabetesDrug: Glargine insulinUniversity of Minnesota - Clinical and Translational Science InstituteSanofi;Moran, Antoinette, M.D.Completed12 YearsN/ABoth20Phase 3United States
115NCT00056147
(ClinicalTrials.gov)		April 20036/3/2003Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung DiseaseMulti-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of INS37217 Inhalation Solution in Subjects With Mild to Moderate Cystic Fibrosis Lung DiseaseCystic FibrosisDrug: denufosol tetrasodium (INS37217)Merck Sharp & Dohme Corp.Cystic Fibrosis Foundation TherapeuticsCompleted8 Years50 YearsBoth90Phase 2United States
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
116NCT00376428
(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
117NCT00043342
(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
118NCT02269189
(ClinicalTrials.gov)		April 200216/10/2014Safety, Tolerability and Pharmacokinetics of BIIL 284 BS in Adult and Pediatric Cystic Fibrosis (CF) PatientsA Randomized, Double-blind Within Dose, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Repeated Oral Doses (15-day Dosing) of BIIL 284 BS in Adult (300 mg) and Pediatric (150 mg) Cystic Fibrosis PatientsCystic FibrosisDrug: BIIL 284 BS, high dose;Drug: BIIL 284 BS, low dose;Drug: PlaceboBoehringer IngelheimNULLCompleted6 YearsN/ABoth36Phase 1NULL
119NCT00005110
(ClinicalTrials.gov)		April 200013/4/2000A Multi-Centered Study of the Long-Term Effect of Salmeterol and Albuterol in Cystic FibrosisCystic FibrosisDrug: Salmeterol;Drug: AlbuterolNational Center for Research Resources (NCRR)NULLSuspended5 Years45 YearsBothN/AUnited States
120NCT00005112
(ClinicalTrials.gov)		April 200015/4/2000Growth Hormone Use in Cystic Fibrosis - a Multicenter StudyCystic FibrosisDrug: Human recombinant growth hormoneNational Center for Research Resources (NCRR)Genentech, Inc.Completed5 Years12 YearsBothPhase 3United States
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
121EUCTR2008-002673-13-DE
(EUCTR)		27/08/2008Anti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and PlaceboAnti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo Deficiency of the Cftr-molecule results in accumulation of ceramide in respiratory epithelial cells. Ceramide triggers a pro-inflammatory and -apoptotic status in cystic fibrosis patients. Amitriptyline reduces ceramide levels in the lung tissue, normalises the activity of cytokines and prevents constitutive cell death of epithelial cells. Amitriptyline prevents pulmonary infections of CF-mice with P. aeruginosa. Amitriptyline may result in an improved lung function of cystic fibrosis patients.Trade Name: Amitriptylin-CT
Product Name: Amitriptyline
INN or Proposed INN: Amitriptyline		PSKSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		Germany
122EUCTR2018-002624-16-FR
(EUCTR)		21/11/2018NA Validation of respiratory epithelial functional assessment to predict clinical efficacy of Orkambi®. Pathway to personalized therapy in Cystic Fibrosis PREDICT-CF - PREDICT-CF Homozygous F508del patient aged 12 years or older
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]		ASSISTANC-PUBLIQUE-HOPITAUX DE PARIS (AP-HP)NULLNA Female: yes
Male: yes		104Phase 4France
123EUCTR2017-001379-21-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]		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		75Phase 3United States;Canada;Ireland;Germany;United Kingdom
124EUCTR2016-001840-20-Outside-EU/EEA
(EUCTR)		18/05/2016Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis PatientsA Multi-center, Human Factors Engineering (HFE) Usability Study in Cystic Fibrosis Patients to Validate the Approved Instructions for Use (IFU) of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Using Placebo Capsules. 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] - Bacterial Infections and Mycoses [C01]		Trade Name: TOBI PodhalerNovartis Pharmaceuticals CorporationNULLNAFemale: yes
Male: yes		45Phase 4United States
125EUCTR2017-001379-21-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]		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		75Phase 3United States;Canada;Ireland;Germany;United Kingdom

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