Liposomal Cyclosporine A ( DrugBank: Cyclosporine )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
228閉塞性細気管支炎20

228. 閉塞性細気管支炎


臨床試験数 : 97 薬物数 : 118 - (DrugBank : 32) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 156
No.TrialIDDate_
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registration
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PhaseCountries
1EUCTR2018-003205-25-DK
(EUCTR)
15/02/202228/09/2021Clinical research study to investigate efficacy and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after double lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation - BOSTON-2 Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation
MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Zambon SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3France;United States;Spain;Belgium;Austria;Denmark;Israel;Germany;United Kingdom
2EUCTR2019-002987-29-AT
(EUCTR)
23/04/202021/01/2020Clinical research study to investigate efficacy and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis Obliterans Syndrome after Single or Double Lung Transplantation.An Open Label Follow-Up Study to Evaluate the Long Term Safety and Efficacy of L-CSA in Patients with a Diagnosis of CLAD-BOS after they have completed the participation to BOSTON 1 and BOSTON 2 studies. Bronchiolitis Obliterans Syndrome in Patients post Single or post Double Lung Transplantation
MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Zambon SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 3France;United States;Spain;Belgium;Austria;Israel;Germany;United Kingdom
3NCT04039347
(ClinicalTrials.gov)
March 3, 202019/7/2019Open-Label, Extension Trial to Demonstrate the Effectiveness and Safety of L-CsA Plus Standard of Care in the Treatment of BOS in Patients Post Single or Double Lung TransplantA Phase III, Multicenter Open-Label, Extension Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosprine A (L-CsA) Inhalation Solution Delivered Via the PARI Investigational eFlow® Device Plus Standard of Care in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Single or Double Lung TransplantationBronchiolitis Obliterans;Obliterative Bronchiolitis;Bronchiolitis Obliterans SyndromeDrug: Liposomal Cyclosporine A 5 mg;Drug: Liposomal Cyclosporine A 10 mgZambon SpANULLEnrolling by invitation18 YearsN/AAll220Phase 3United States;Austria;Belgium;France;Germany;Israel;Spain;United Kingdom
4EUCTR2019-002987-29-ES
(EUCTR)
28/02/202020/12/2019Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis Obliterans Syndrome after Single or Double Lung Transplantation.A Phase III, Multicenter, Open-Label, Extension Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Single or Double Lung Transplantation Bronchiolitis Obliterans Syndrome in Patients post Single or post Double Lung Transplantation
MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
BREATH Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
220 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Belgium;Spain;Austria;Israel;Germany;United Kingdom
5EUCTR2019-002987-29-DE
(EUCTR)
12/02/202026/11/2019Clinical research study to investigate efficacy and safety of LiposomalCyclosporine A (L-CsA) in patients with Bronchiolitis Obliterans Syndromeafter Single or Double Lung Transplantation.An Open Label Follow-Up Study to Evaluate the Long Term Safety andEfficacy of L-CSA in Patients with a Diagnosis of CLAD-BOS after they havecompleted the participation to BOSTON 1 and BOSTON 2 studies. Bronchiolitis Obliterans Syndrome in Patients post Single or post Double Lung Transplantation
MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Zambon SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 3France;United States;Spain;Belgium;Austria;Israel;Germany;United Kingdom
6NCT04107675
(ClinicalTrials.gov)
February 11, 202025/9/2019A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis After Hematopoietic Transplant (BOSTON-4)A Phase IIa Multi-Center, Randomized, Single-Blind Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell TransplantationBronchiolitis Obliterans;GVHD, Chronic;Stem Cell Transplant ComplicationsDrug: Liposomal Cyclosporine A;Drug: Liposomal PlaceboZambon SpANULLActive, not recruiting18 YearsN/AAll6Phase 2France;Germany;Spain
7EUCTR2019-002987-29-FR
(EUCTR)
23/01/202023/01/2020Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis Obliterans Syndrome after Single or Double Lung Transplantation.A Phase III, Multicenter, Open-Label, Extension Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Single or Double Lung Transplantation - BOSTON-3 Bronchiolitis Obliterans Syndrome in Patients post Single or post Double Lung Transplantation
MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
BREATH Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 3United States;France;Spain;Belgium;Austria;Israel;Germany;United Kingdom
8EUCTR2019-000718-13-DE
(EUCTR)
17/12/201906/06/2019A Clinical Research Study to Investigate the Safety and Tolerability ofinhaled Liposomal Cyclosporine A (L-CsA) in Patients with BronchiolitisObliterans Syndrome after Allogeneic Hematopoietic Stem CellTransplantation.BOSTON-4: A Phase IIa Multi-Center, Randomized, Single-Blind Safety andTolerability Study of inhaled Liposomal Cyclosporine A in BronchiolitisObliterans Syndrome Following Allogeneic Hematopoietic Stem CellTransplantation - BOSTON-4 Bronchiolitis Obliterans Syndrome in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Zambon SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2France;Spain;Germany
9EUCTR2019-000718-13-FR
(EUCTR)
03/12/201925/11/2019A Clinical Research Study to Investigate the Safety of Liposomal Cyclosporine A (L-CsA) in Patients with Bronchiolitis Obliterans Syndrome after Allogeneic Hematopoietic Stem Cell Transplantation.A Phase IIa Multi-Center, Randomized, Single-Blind Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell Transplantation. - BOSTON-4 Bronchiolitis Obliterans Syndrome in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Breath Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2France;Spain;Germany
10EUCTR2019-000718-13-ES
(EUCTR)
27/11/201905/11/2019A Clinical Research Study to Investigate the Safety of Liposomal Cyclosporine A (L-CsA) in Patients with Bronchiolitis Obliterans Syndrome after Allogeneic Hematopoietic Stem Cell Transplantation.A Phase IIa Multi-Center, Randomized, Single-Blind Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell Transplantation. - BOSTON-4 Bronchiolitis Obliterans Syndrome in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Breath Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain
11EUCTR2018-003204-39-GB
(EUCTR)
21/10/201914/01/2019Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after single lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation - BOSTON-1 Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
BREATH Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;France;Spain;Israel;Germany;United Kingdom
12EUCTR2018-003205-25-GB
(EUCTR)
11/09/201914/01/2019Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after double lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation - BOSTON-2 Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
BREATH Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3United States;France;Spain;Belgium;Austria;Israel;Germany;United Kingdom
13EUCTR2018-003205-25-AT
(EUCTR)
02/04/201904/12/2018Clinical research study to investigate efficacy and safety of LiposomalCyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndromeafter double lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trialto Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (LCsA)Inhalation Solution Delivered via the PARI Investigational eFlow®Device plus Standard of Care versus Standard of Care Alone in theTreatment of Chronic Lung Allograft Dysfunction / Bronchiolitis ObliteransSyndrome in Patients post Double Lung Transplantation - BOSTON-2 Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndromein Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Zambon SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
152Phase 3United States;France;Spain;Belgium;Austria;Israel;Germany;United Kingdom
14NCT03656926
(ClinicalTrials.gov)
March 29, 201930/8/2018A Clinical Trial to Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A Inhalation Solution in the Treatment of CLAD/Bronchiolitis Obliterans Syndrome in Patients Post Double Lung TransplantA Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered Via the PARI Investigational eFlow® Device Plus Standard of Care Versus Standard of Care Alone in the Treatment of Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndrome in Patients Post Double Lung TransplantationBronchiolitis Obliterans;Chronic Rejection of Lung Transplant;Lung Transplant Rejection;Lung Transplant; Complications;Lung Transplant Failure and Rejection;Chronic Lung Allograft DysfunctionDrug: Liposomal Cyclosporine AZambon SpANULLRecruiting18 YearsN/AAll110Phase 3United States;Austria;Belgium;France;Germany;Israel;Spain;United Kingdom
15NCT03657342
(ClinicalTrials.gov)
March 26, 201930/8/2018A Clinical Trial to Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A Inhalation Solution in the Treatment of CLAD/Bronchiolitis Obliterans Syndrome in Patients Post Single Lung TransplantA Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered Via the PARI Investigational eFlow® Device Plus Standard of Care Versus Standard of Care Alone in the Treatment of Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndrome in Patients Post Single Lung TransplantationBronchiolitis Obliterans;Chronic Rejection of Lung Transplant;Lung Transplant Rejection;Lung Transplant; Complications;Lung Transplant Failure and Rejection;Chronic Lung Allograft DysfunctionDrug: Liposomal Cyclosporine AZambon SpANULLRecruiting18 YearsN/AAll110Phase 3United States;France;Germany;Israel;Spain;United Kingdom
16EUCTR2018-003205-25-DE
(EUCTR)
04/03/201915/11/2018Clinical research study to investigate efficacy and safety of LiposomalCyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndromeafter double lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trialto Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (LCsA)Inhalation Solution Delivered via the PARI Investigational eFlow®Device plus Standard of Care versus Standard of Care Alone in theTreatment of Chronic Lung Allograft Dysfunction / Bronchiolitis ObliteransSyndrome in Patients post Double Lung Transplantation - BOSTON-2 Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndromein Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Zambon SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3France;United States;Spain;Belgium;Austria;Israel;Germany;United Kingdom
17EUCTR2018-003205-25-ES
(EUCTR)
01/03/201918/01/2019Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after double lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation - BOSTON-2 Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
BREATH Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
110 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Belgium;Spain;Austria;Israel;Germany;United Kingdom
18EUCTR2018-003204-39-DE
(EUCTR)
20/02/201915/11/2018Clinical research study to investigate efficacy and safety of LiposomalCyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndromeafter single lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trialto Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (LCsA)Inhalation Solution Delivered via the PARI Investigational eFlow®Device plus Standard of Care versus Standard of Care Alone in theTreatment of Chronic Lung Allograft Dysfunction / Bronchiolitis ObliteransSyndrome in Patients post Single Lung Transplantation - BOSTON-1 Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndromein Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
ZAMBON SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3France;United States;Spain;Israel;Germany;United Kingdom
19EUCTR2018-003204-39-ES
(EUCTR)
08/02/201918/01/2019Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after single lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation - BOSTON-1 Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
BREATH Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Spain;Israel;Germany;United Kingdom
20EUCTR2018-003204-39-FR
(EUCTR)
09/01/201913/11/2018Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after single lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation - BOSTON-1 Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
BREATH Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;France;Spain;Israel;Germany;United Kingdom