228. 閉塞性細気管支炎
[臨床試験数:92,薬物数:125(DrugBank:34),標的遺伝子数:33,標的パスウェイ数:152

Searched query = "Bronchiolitis obliterans", "Obliterating bronchiolitis"
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"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04655508
(ClinicalTrials.gov)
March 202110/11/2020Efficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 =10% From Pre TransplantationEfficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 =10% From Pre TransplantationStem Cell Transplant Complications;Respiratory Disease;Bronchiolitis ObliteransDrug: Seretide;Drug: PlaceboAssistance Publique - Hôpitaux de ParisGlaxoSmithKlineNot yet recruiting6 Years17 YearsAll243Phase 3France
2NCT04239989
(ClinicalTrials.gov)
December 15, 202030/12/2019Itacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell TransplantA Phase I Study to Assess Safety of Selective JAK 1 Inhibitor, Itacitinib, in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Allogeneic Hematopoietic Cell Transplant (HCT)Bronchiolitis ObliteransDrug: Itacitinib;Drug: Itacitinib AdipateM.D. Anderson Cancer CenterNational Cancer Institute (NCI)Not yet recruiting18 Years75 YearsAll15Phase 1United States
3NCT03603899
(ClinicalTrials.gov)
August 20204/10/2017Hp129 Xenon Imaging and BOS in Lung TransplantationImaging and Understanding Bronchiolitis Obliterans Syndrome (BOS) in Lung Transplantation With Hyperpolarized 129Xenon MR Lung ImagingBronchiolitis ObliteransDrug: Hp 129XenonChildren's Hospital Medical Center, CincinnatiNULLRecruiting6 YearsN/AAll45Phase 1;Phase 2United States
4EUCTR2019-002987-29-AT
(EUCTR)
23/04/202021/01/2020Clinical 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 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
5NCT04039347
(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 mgBreath Therapeutics Inc.NULLEnrolling by invitation18 YearsN/AAll220Phase 3United States;Austria;Belgium;France;Germany;Israel;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
6EUCTR2019-002987-29-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]
BREATH Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
220Phase 3France;United States;Belgium;Spain;Austria;Israel;Germany;United Kingdom
7EUCTR2019-002987-29-DE
(EUCTR)
12/02/202026/11/2019Clinical 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 finishedFemale: yes
Male: yes
220Phase 3Germany;United Kingdom;France;United States;Belgium;Spain;Austria;Israel
8NCT04107675
(ClinicalTrials.gov)
February 11, 202025/9/2019A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell TransplantA 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 PlaceboBreath Therapeutics Inc.NULLRecruiting18 YearsN/AAll24Phase 2France;Germany;Spain
9NCT03978637
(ClinicalTrials.gov)
February 4, 20205/6/2019Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung TransplantationAn Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung TransplantationBronchiolitis Obliterans SyndromeDrug: ItacitinibIncyte CorporationNULLRecruiting18 YearsN/AAll75Phase 1;Phase 2United States;Belgium;Canada
10EUCTR2019-000718-13-DE
(EUCTR)
17/12/201906/06/2019A 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 2Spain;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2019-000718-13-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]Breath Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
24Phase 2Spain
12NCT03283007
(ClinicalTrials.gov)
October 30, 20196/9/2017Nintedanib in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome Grade 1-2A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Transplant (LTx) Recipients With Bronchiolitis Obliterans Syndrome (BOS) Grade 1-2Lung-transplant RecipientsDrug: Nintedanib;Drug: PlaceboAssistance Publique - Hôpitaux de ParisNULLRecruiting18 YearsN/AAll80Phase 3France
13EUCTR2018-003204-39-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
14EUCTR2018-003205-25-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
15NCT04029636
(ClinicalTrials.gov)
August 20197/6/2019Hyperpolarized 129Xe MRI for the Assessment of BOS With Late Onset LONIPCHyperpolarized 129Xe Magnetic Resonance Imaging for the Early Detection of Bronchiolitis Obliterans Syndrome (BOS) and Other Late Onset Non-infectious Pulmonary Complications (LONIPCs) Following Hematopoietic Stem Cell TransplantationBronchiolitis ObliteransOther: Inhaled Hyperpolarized Xenon-129Hamilton Health Sciences CorporationNULLNot yet recruiting18 Years70 YearsAll45Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT03674047
(ClinicalTrials.gov)
April 19, 201914/9/2018Ruxolitinib for Bronchiolitis Obliterans Syndrome (BOS) After Allogeneic Hematopoietic Cell Transplantation (HCT)A Phase II Study of Ruxolitinib for Bronchiolitis Obliterans Syndrome (BOS) After Allogeneic Hematopoietic Cell Transplantation (HCT)Other CancerDrug: ruxolitinibMassachusetts General HospitalIncyte CorporationRecruiting18 Years75 YearsAll50Phase 2United States
17EUCTR2018-001747-31-FR
(EUCTR)
09/04/201928/12/2018 A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Transplant (LTx) recipients with bronchiolitis obliterans syndrome (BOS) grade 1-2 A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Tranplant (LTx) recipients with bronchiolitis obliterans sydrome (BOS) grade 1-2 - INFINITX BOS Bronchiolitis Obliterating Syndrome (SBO) grade 1 or 2 in patients with pulmonary transplantation.
MedDRA version: 20.0;Level: PT;Classification code 10029888;Term: Obliterative bronchiolitis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
80Phase 3France
18EUCTR2018-003205-25-AT
(EUCTR)
02/04/201904/12/2018Clinical 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 finishedFemale: yes
Male: yes
110Phase 3United States;France;Spain;Belgium;Austria;Israel;Germany;United Kingdom
19NCT03656926
(ClinicalTrials.gov)
March 29, 201930/8/2018A Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A Inhalation Solution in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Double Lung TransplantA 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 TransplantationBronchiolitis Obliterans;Chronic Rejection of Lung Transplant;Lung Transplant Rejection;Lung Transplant; Complications;Lung Transplant Failure and RejectionDrug: Liposomal Cyclosporine ABreath Therapeutics Inc.NULLRecruiting18 YearsN/AAll110Phase 3United States;Austria;Belgium;France;Germany;Israel;Spain;United Kingdom
20NCT03657342
(ClinicalTrials.gov)
March 26, 201930/8/2018A Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A Inhalation Solution in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Single Lung TransplantA 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 TransplantationBronchiolitis Obliterans;Chronic Rejection of Lung Transplant;Lung Transplant Rejection;Lung Transplant; Complications;Lung Transplant Failure and RejectionDrug: Liposomal Cyclosporine ABreath Therapeutics Inc.NULLRecruiting18 YearsN/AAll110Phase 3United States;France;Germany;Israel;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
21NCT03805477
(ClinicalTrials.gov)
March 20, 20198/1/2019Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell TransplantationNintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation (HSCT)- a Multicentre Phase II TrialBronchiolitis Obliterans Syndrome (BOS);Bronchiolitis Obliterans (BO)Drug: NintedanibUniversity Hospital, Basel, SwitzerlandNULLRecruiting18 YearsN/AAll40Phase 2Austria;Germany;Switzerland
22EUCTR2018-003205-25-DE
(EUCTR)
04/03/201915/11/2018Clinical 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 finishedFemale: yes
Male: yes
110Phase 3United States;France;Spain;Belgium;Austria;Israel;Germany;United Kingdom
23EUCTR2018-003205-25-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]BREATH Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
110Phase 3France;United States;Belgium;Spain;Austria;Israel;Germany;United Kingdom
24EUCTR2018-003204-39-DE
(EUCTR)
20/02/201915/11/2018Clinical 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 finishedFemale: yes
Male: yes
130Phase 3United States;France;Spain;Israel;Germany;United Kingdom
25EUCTR2018-003204-39-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]BREATH Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
130Phase 3France;United States;Spain;Israel;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
26EUCTR2018-003204-39-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]BREATH Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
130Phase 3United States;France;Spain;Israel;Germany;United Kingdom
27NCT03315741
(ClinicalTrials.gov)
March 1, 20185/10/2017The Safety and Tolerability of Pirfenidone for BOS After HCTThe Safety and Tolerability of Pirfenidone for Bronchiolitis Obliterans Syndrome After Hematopoietic Cell TransplantationBronchiolitis Obliterans;Graft Vs Host DiseaseDrug: Pirfenidone 267 MG [Esbriet]Stanford UniversityGenentech, Inc.Recruiting18 YearsN/AAll30Phase 1United States
28NCT02669251
(ClinicalTrials.gov)
April 28, 201629/1/2016Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell TransplantationA Phase 1b/2 Study of Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell TransplantationChronic Graft vs Host Disease;Chronic Graft-Versus-Host-Disease;Bronchiolitis Obliterans SyndromeDrug: MPH966National Cancer Institute (NCI)NULLRecruiting18 Years99 YearsAll34Phase 1;Phase 2United States
29NCT02863835
(ClinicalTrials.gov)
April 20164/5/2016Evaluation of Electrical Impedance Tomography for the Diagnosis of Chronic Rejection in Lung Transplants RecipientsEvaluation of Electrical Impedance Tomography for the Diagnosis of Chronic Rejection in Lung Transplants RecipientsTransplantation, Heart-Lung;Chronic Lung Allograft Dysfunction;Bronchiolitis Obliterans SyndromeOther: EIT;Other: Salbutamol nebulisation and with CPAPGuy's and St Thomas' NHS Foundation TrustADIR AssociationCompleted18 Years70 YearsAll50N/AUnited Kingdom
30EUCTR2014-002022-12-SE
(EUCTR)
06/08/201515/10/2014European Trial of Pirfenidone in BOS (EPOS).A European multi-centre, randomised, double-blind trial of pirfenidone in bronchiolitis-obliterans-syndrome grade 1-3 in lung transplant recipients. - EPOS Trial Bronchiolitis Obliterans Syndrome (BOS) in patients following lung transplantation. This syndrome occurs due to rejection of the transplanted organ (s).
MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Pirfenidone
INN or Proposed INN: PIRFENIDONE
Other descriptive name: 5-Methyl-1-Phenyl-2-1-(H)-Pyridone
Clinical Trials Unit, RigshospitaletNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2Belgium;Denmark;Netherlands;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2014-002022-12-NL
(EUCTR)
13/05/201503/11/2014European Trial of Pirfenidone in BOS (EPOS).A European multi-centre, randomised, double-blind trial of pirfenidone in bronchiolitis-obliterans-syndrome grade 1-3 in lung transplant recipients. - EPOS Trial Bronchiolitis Obliterans Syndrome (BOS) in patients following lung transplantation. This syndrome occurs due to rejection of the transplanted organ (s).
MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Clinical Trials Unit, RigshospitaletNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
80Phase 2Belgium;Denmark;Germany;Netherlands;United Kingdom;Sweden
32NCT02262299
(ClinicalTrials.gov)
May 201521/9/2014European Trial of Pirfenidone in BOS, A European Multi-center StudyA European Multi-center, Randomised, Double-blind Trial of Pirfenidone in Bronchiolitis-obliterans-syndrome Grade 1-3 in Lung Transplant RecipientsDisorder Related to Lung Transplantation;CLAD, Bronchiolitis ObliteransDrug: Pirfenidone;Drug: PlaceboRigshospitalet, DenmarkNULLCompleted18 YearsN/AAll90Phase 2;Phase 3Belgium;Denmark;Germany;Netherlands;Norway;Sweden;United Kingdom
33NCT03072849
(ClinicalTrials.gov)
April 20152/3/2017Early Detection and Management of Bronchiolitis Obliterans Syndrome Following Pediatric Hematopoietic Stem Cell TransplantationEarly Detection and Management of Bronchiolitis Obliterans Syndrome Following Pediatric Hematopoietic Stem Cell TransplantationBronchiolitis Obliterans SyndromeProcedure: Pulmonary function testing;Drug: FAM TherapyAnn & Robert H Lurie Children's Hospital of ChicagoNULLRecruiting6 Years18 YearsAll40N/AUnited States
34EUCTR2014-002022-12-BE
(EUCTR)
10/03/201515/10/2014European Trial of Pirfenidone in BOS (EPOS).A European multi-centre, randomised, double-blind trial of pirfenidone in bronchiolitis-obliterans-syndrome grade 1-3 in lung transplant recipients. - EPOS Trial Bronchiolitis Obliterans Syndrome (BOS) in patients following lung transplantation. This syndrome occurs due to rejection of the transplanted organ (s).
MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000015490;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Pirfenidone
INN or Proposed INN: PIRFENIDONE
Other descriptive name: 5-Methyl-1-Phenyl-2-1-(H)-Pyridone
Clinical Trials Unit, RigshospitaletNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2Belgium;Denmark;Netherlands;Germany;United Kingdom;Sweden
35EUCTR2014-002022-12-GB
(EUCTR)
06/01/201515/10/2014European Trial of Pirfenidone in BOS (EPOS).A European multi-centre, randomised, double-blind trial of pirfenidone in bronchiolitis-obliterans-syndrome grade 1-3 in lung transplant recipients. - EPOS Trial Bronchiolitis Obliterans Syndrome (BOS) in patients following lung transplantation. This syndrome occurs due to rejection of the transplanted organ (s).
MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Clinical Trials Unit, RigshospitaletNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
90Phase 2Belgium;Denmark;Netherlands;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2014-002022-12-DE
(EUCTR)
30/12/201421/10/2014European Trial of Pirfenidone in BOS (EPOS).A European multi-centre, randomised, double-blind trial of pirfenidone in bronchiolitis-obliterans-syndrome grade 1-3 in lung transplant recipients. - EPOS Trial Bronchiolitis Obliterans Syndrome (BOS) in patients following lung transplantation. This syndrome occurs due to rejection of the transplanted organ (s).
MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Clinical Trials Unit, RigshospitaletNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
80Phase 2Belgium;Denmark;Netherlands;Germany;United Kingdom;Sweden
37EUCTR2014-002022-12-DK
(EUCTR)
15/12/201404/11/2014European Trial of Pirfenidone in BOS (EPOS).A European multi-centre, randomised, double-blind trial of pirfenidone in bronchiolitis-obliterans-syndrome grade 1-3 in lung transplant recipients. - EPOS Trial Bronchiolitis Obliterans Syndrome (BOS) in patients following lung transplantation. This syndrome occurs due to rejection of the transplanted organ (s).
MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Pirfenidone
INN or Proposed INN: PIRFENIDONE
Other descriptive name: 5-Methyl-1-Phenyl-2-1-(H)-Pyridone
Clinical Trials Unit, RigshospitaletNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2Belgium;Denmark;Netherlands;Germany;United Kingdom;Sweden
38NCT02316392
(ClinicalTrials.gov)
December 201410/12/2014Imaging and Understanding BOS in Lung TransplantationImaging and Understanding BOS in Lung TransplantationBronchiolitis Obliterans SyndromeDrug: Hyperpolarized Helium-3 MRIChildren's Hospital Medical Center, CincinnatiNULLCompleted1 Year25 YearsAll6N/AUnited States
39NCT02543073
(ClinicalTrials.gov)
September 20144/9/2015MSC for Treatment of Interstitial Lung Disease After Allo-HSCTMesenchymal Stem Cell for Treatment of Interstitial Lung Disease After Allogenetic Hematopoietic Stem Cell TransplantationLung Diseases, Interstitial;Hematopoietic Stem Cell Transplantation;Bronchiolitis ObliteransBiological: MSCs;Drug: AZM;Drug: GlucocorticoidNanfang Hospital of Southern Medical UniversitySun Yat-sen UniversityRecruiting18 Years65 YearsAll60Phase 1;Phase 2China
40NCT02181712
(ClinicalTrials.gov)
July 20142/7/2014Mesenchymal Stem Cell Therapy for Lung RejectionA Pilot Study to Evaluate the Safety and Feasibility of Mesenchymal Stem Cells to Induce Remission in Lung Transplant Patients Experiencing Treatment-refractory Moderate to Severe Lung RejectionLung Transplant Reject;Bronchiolitis ObliteransBiological: Mesenchymal stem cell 0.5;Biological: Mesenchymal stem cell 1.0Mayo ClinicNULLActive, not recruiting18 Years75 YearsAll19Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT01959100
(ClinicalTrials.gov)
February 20147/10/2013Efficacy of Azithromycin to Prevent Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell TransplantationEvaluation of the Efficacy of Azithromycin to Prevent Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell TransplantationMalignant Hematological DiseasesDrug: Azithromycin;Drug: PlaceboAssistance Publique - Hôpitaux de ParisNULLActive, not recruiting16 YearsN/AAll480Phase 3France
42EUCTR2013-000499-14-FR
(EUCTR)
30/08/201325/09/2015N/AN/A - ALLOZITHRO
MedDRA version: 18.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855
Trade Name: AZITHROMYCINE 250 mg
Product Name: AZITHROMYCINE 250 mg
INN or Proposed INN: AZITHROMYCINE
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLNot RecruitingFemale: yes
Male: yes
Phase 3France
43EUCTR2012-003331-32-BE
(EUCTR)
18/06/201312/11/2012A PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PRE-TRANSPLANT AND PROMPT POST-TRANSPLANT TREATMENT WITH AZITHROMYCIN TO IMPROVE EARLY ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATIONA PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PRE-TRANSPLANT AND PROMPT POST-TRANSPLANT TREATMENT WITH AZITHROMYCIN TO IMPROVE EARLY ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATION EARLY LUNG ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATION
MedDRA version: 14.1;Level: LLT;Classification code 10050437;Term: Prophylaxis against heart and lung transplant rejection;System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1;Classification code 10016547;Term: FEV;System Organ Class: 10022891 - Investigations
MedDRA version: 14.1;Classification code 10050433;Term: Prophylaxis against lung transplant rejection;Classification code 10006414;Term: Bronchial biopsy abnormal;Classification code 10025041;Term: Lung biopsy abnormal;Classification code 10016549;Term: FEV 1 abnormal;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10025127;Term: Lung transplant;Classification code 10049237;Term: Acute cellular rejection;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 14.1;Classification code 10066543;Term: Acute allograft rejection;Classification code 10039008;Term: Reversible airways obstruction NOS;Classification code 10019319;Term: Heart-lung transplant rejection;Level: LLTClassi;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Azithromycin (Zitromax°)
Product Name: Zitromax
Product Code: not applicable
INN or Proposed INN: AZITHROMYCIN
Other descriptive name: AZITHROMYCIN
KULeuven and University Hospitals LeuvenNULLNot RecruitingFemale: yes
Male: yes
60Phase 4Belgium
44NCT01469364
(ClinicalTrials.gov)
March 20138/11/2011Safety Study of Aztreonam Lysine for Inhalation (AZLI) in the Treatment of Early Bronchiolitis Obliterans Syndrome (BOS)Aztreonam Lysine for Inhalation (AZLI) in the Treatment of Early Bronchiolitis Obliterans Syndrome (BOS) After Lung TransplantationComplication of Transplanted LungDrug: Aztreonam Lysine for Inhalation (AZLI);Procedure: Status Post Lung TransplantDuke UniversityGilead SciencesCompleted18 YearsN/AAll30Phase 4United States
45EUCTR2011-004304-38-ES
(EUCTR)
19/09/201222/06/2012An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy - Not applicable Prevention of Bronchiolitis Obliterans Syndrome in lung transplant
MedDRA version: 14.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Aerolised Liposomal Ciclosporin A 5mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A 10mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
180France;Canada;Belgium;Spain;Denmark;Austria;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
46NCT01639261
(ClinicalTrials.gov)
July 20129/7/2012A Phase II Trial on Treatment of Steroid-refractory Bronchiolitis Obliterans With Interferon Gamma 1b After Allogeneic SCTEine Phase II Studie über Interferon Gamma 1b Zur Behandlung Der steroidrefraktären Bronchiolitis Obliterans Nach Allogener SZTSteroid-refractory Bronchiolitis ObliteransDrug: Interferon gamma 1bUniversity Hospital RegensburgClinAssess GmbHActive, not recruiting18 YearsN/ABoth10Phase 2Germany
47NCT01650545
(ClinicalTrials.gov)
July 201227/6/2012Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant RecipientsA Pilot Study to Demonstrate Efficacy and Safety of Aerosol Liposomal Cyclosporine (L-CsA) in the Treatment of Bronchiolitis Obliterans Syndrome After Lung TransplantationDisorder Related to Lung Transplantation;Bronchiolitis Obliterans;Decreased Immunologic Activity;Chronic Rejection of Lung TransplantDrug: Liposomal aerosol cyclosporine;Other: standard immune suppression, oralUniversity of Maryland, College ParkNULLCompleted18 YearsN/AAll21Phase 1;Phase 2United States
48EUCTR2011-004304-38-GB
(EUCTR)
14/06/201209/12/2011An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy - Not applicable Prevention of Bronchiolitis Obliterans Syndrome in lung transplant
MedDRA version: 14.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Aerolised Liposomal Ciclosporin A 5mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A 10mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
49EUCTR2011-004304-38-AT
(EUCTR)
13/03/201220/12/2011An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy Prevention of Bronchiolitis Obliterans Syndrome in lung transplant
MedDRA version: 15.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Aerolised Liposomal Ciclosporin A 5mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A 10mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
180France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
50NCT01273207
(ClinicalTrials.gov)
March 2, 20127/1/2011Extension Study (Extended Access) of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis ObliteransExtension Study (Extended Access) of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis ObliteransBronchiolitis Obliterans;Constructive Bronchiolitis;Graft Versus Host Disease;Bronchiolitis, Exudative;Bronchiolitis, Proliferative;Graft-Versus-Host DiseaseDrug: Cyclosporine Inhalation Solution (CIS)National Heart, Lung, and Blood Institute (NHLBI)NULLCompleted10 Years80 YearsAll7Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2011-004304-38-BE
(EUCTR)
14/02/201215/12/2011An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy - Not applicable Prevention of Bronchiolitis Obliterans Syndrome in lung transplant
MedDRA version: 14.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Aerolised Liposomal Ciclosporin A 5mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A 10mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3France;Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom
52NCT01439958
(ClinicalTrials.gov)
February 201222/9/2011Long-term Safety Follow-up Study in the Prevention of Bronchiolitis Obliterans Syndrome (BOS)A Long-term Safety Follow-up Study of L-CsA Therapy for Patients Who Participated in Study 12011.201 and Volunteered to Continue or to Cross-over to L-CsA Inhalation TherapyBronchiolitis ObliteransDrug: InhalationPari Pharma GmbHNULLTerminated18 Years80 YearsBoth14Phase 3Germany
53EUCTR2011-004304-38-DK
(EUCTR)
20/01/201219/12/2011An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy - Not applicable Prevention of Bronchiolitis Obliterans Syndrome in lung transplant
MedDRA version: 14.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Aerolised Liposomal Ciclosporin A 5mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A 10mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3France;Canada;Belgium;Spain;Austria;Denmark;Germany;United Kingdom
54EUCTR2011-004304-38-DE
(EUCTR)
06/01/201228/11/2011An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy Prevention of Bronchiolitis Obliterans Syndrome in lung transplant
MedDRA version: 14.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Aerolised Liposomal Ciclosporin A 5mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A 10mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
40France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
55NCT01432080
(ClinicalTrials.gov)
September 20118/9/2011Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post AllotransplantDoes Increasing Immunosuppression Prevent Transplant-associated Lung-disease Triggered by Viral Respiratory Tract Infection Following Allogeneic Stem Cell Transplant? A Pilot StudyRespiratory Tract Infections;Bronchiolitis Obliterans;Cryptogenic Organizing Pneumonia;Lung Diseases, InterstitialDrug: Prednisone;Drug: Azithromycin;Drug: Montelukast;Drug: SymbicortMaisonneuve-Rosemont HospitalThe Canadian Blood and Marrow Transplant GroupTerminated18 YearsN/AAll12Phase 2Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT01307462
(ClinicalTrials.gov)
June 20111/3/2011Targeted Therapy of Bronchiolitis Obliterans SyndromeFluticasone Propionate, Azithromycin, and Montelukast Sodium in Treating Patients With Bronchiolitis Obliterans Who Previously Underwent Stem Cell TransplantBronchiolitis ObliteransDrug: fluticasone propionate;Drug: montelukast sodium;Drug: azithromycinStephanie LeeNational Cancer Institute (NCI)Completed6 Years99 YearsAll36Phase 2United States
57NCT01327625
(ClinicalTrials.gov)
March 201131/3/2011Efficacy Study of Azithromycin-based Therapy for Bronchiolitis ObliteransA Pilot Study Evaluating the Efficacy of Azithromycin, N-acetylcystein and Inhaled Corticosteroid Combination Therapy for Bronchiolitis Obliterans After Allogeneic Hematopoietic Cell TranspantationGraft vs Host Disease;Bronchiolitis ObliteransDrug: azithromycin + N-acetylcystein + inhaled corticosteroidAsan Medical CenterNULLTerminated15 Years75 YearsBoth6N/AKorea, Republic of
58NCT01287078
(ClinicalTrials.gov)
January 29, 201129/1/2011Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans SyndromePhase II Trial of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for Treatment of Bronchiolitis Obliterans SyndromeConstrictive Bronchiolitis;Bronchiolitis Obliterans;Graft vs Host Disease;Bronchiolitis, Exudative;Bronchiolitis, ProliferativeDrug: Cyclosporine Inhalation SolutionNational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted10 Years80 YearsAll25Phase 2United States
59NCT01163786
(ClinicalTrials.gov)
October 7, 20107/7/2010A Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHDA Phase 2 Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHDBronchiolitis ObliteransDrug: BortezomibNorthwestern UniversityRobert H. Lurie Cancer CenterTerminatedN/AN/AAll17Phase 2United States
60NCT01212406
(ClinicalTrials.gov)
October 201028/9/2010Vitamin D in Bronchiolitis Obliterans SyndromeA Randomized Double Blind Placebo Controlled Trial With Vitamin D to Prevent Bronchiolitis Obliterans Syndrome After Lung TransplantationAllograft Rejection;Lung Transplantation;Bronchiolitis ObliteransDrug: Vitamin DUniversitaire Ziekenhuizen LeuvenKatholieke Universiteit LeuvenCompleted18 YearsN/ABoth100Phase 4Belgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT01211509
(ClinicalTrials.gov)
October 201028/9/2010Montelukast in Bronchiolitis Obliterans SyndromeA Randomized, Double Blind, Placebo Controlled Trial With Montelukast to Treat Bronchiolitis Obliterans Syndrome After Lung TransplantationBronchiolitis Obliterans;Lung Transplantation;Graft RejectionDrug: MontelukastUniversitaire Ziekenhuizen LeuvenKatholieke Universiteit LeuvenCompleted18 Years75 YearsBoth30Phase 4Belgium
62EUCTR2010-022027-30-BE
(EUCTR)
23/09/201002/09/2010A randomized placebo-controlled double blind study to prevent BOS - VIT001A randomized placebo-controlled double blind study to prevent BOS - VIT001 A study to prevent the occurence of chronic rejection after lung transplantation. Other points of investigation include lung function evolution, rate of survival, BAL cellularity, infection rate, rate of acute rejection and reflux
MedDRA version: 12.1;Level: LLT;Classification code 10029888;Term: Obliterative bronchiolitis
MedDRA version: 12.1;Classification code 10049202;Term: Bronchiolitis obliterans
MedDRA version: 12.1;Classification code 10068805;Term: Follicular bronchiolitis
MedDRA version: 12.1;Classification code 10019319;Term: Heart-lung transplant rejection
MedDRA version: 12.1;Classification code 10025127;Term: Lung transplant
MedDRA version: 12.1;Classification code 10050433;Term: Prophylaxis against lung transplant rejection
MedDRA version: 12.1;Classification code 10050437;Term: Prophylaxis against heart and lung transplant rejection
MedDRA version: 12.1;Classification code 10051604;Term: Lung transplant rejection
MedDRA version: 12.1;Classification code 10056409;Term: Heart and lung transplant
MedDRA version: 12.1;Classification code 10016547;Term: FEV
MedDRA version: 12.1;Classification code 10016549;Term: FEV 1 abnormal
MedDRA version: 12.1;Classification code 10016550;Term: FEV 1 decreased
MedDRA version: 12.1;Classification code 10016553;Term: FEV 1 low
Trade Name: D-Cure
Product Name: D-cure
INN or Proposed INN: COLECALCIFEROL
UZ GasthuisbergNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Belgium
63EUCTR2010-021983-14-BE
(EUCTR)
23/09/201002/09/2010A randomized placebo-controlled double blind study to treat BOS.A randomized placebo-controlled double blind study to treat BOS. -Mortality at 1 and 2 year post diagnosis of BOS-Infection rate during BOS-Evolution of pulmonary function after diagnosis of BOS
MedDRA version: 12.1;Level: LLT;Classification code 10029888;Term: Obliterative bronchiolitis
MedDRA version: 12.1;Classification code 10049202;Term: Bronchiolitis obliterans
MedDRA version: 12.1;Classification code 10068805;Term: Follicular bronchiolitis
MedDRA version: 12.1;Classification code 10019319;Term: Heart-lung transplant rejection
MedDRA version: 12.1;Classification code 10025127;Term: Lung transplant
MedDRA version: 12.1;Classification code 10051604;Term: Lung transplant rejection
MedDRA version: 12.1;Classification code 10056409;Term: Heart and lung transplant
MedDRA version: 12.1;Classification code 10016547;Term: FEV
MedDRA version: 12.1;Classification code 10016549;Term: FEV 1 abnormal
MedDRA version: 12.1;Classification code 10016550;Term: FEV 1 decreased
MedDRA version: 12.1;Classification code 10016553;Term: FEV 1 low
Trade Name: Montelukast Teva
Product Name: montelukast teva
Product Code: NA
INN or Proposed INN: MONTELUKAST SODIUM
Other descriptive name: Singulair
UZ GasthuisbergNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Belgium
64EUCTR2008-003800-73-BE
(EUCTR)
14/09/201008/01/2009A clinical trial to investigate whether a dose of 10mg or 20mg aerolised liposomal ciclosporin A (L-CsA) is safe and effective to prevent Bronchiolitis Obliterans Syndrome (BOS) in lung transplane patientsA phase III, multicentre, randomised, double-blind, placebo controlled clinical trial to investigate the efficacy and safety of 10 or 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients Prevention of bronchiolitis obliterans syndrome in lung transplant
MedDRA version: 15.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom
65EUCTR2008-003800-73-ES
(EUCTR)
22/07/201026/05/2010A phase II, multicentre,randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patientsEnsayo clínico de fase II, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y búsqueda de dosis para investigar la eficacia y la seguridad de 10 y 20 mg/día de Ciclosporina A Liposómica aerosolizada (L-CsA) frente a placebo aerosolizado en la prevención del síndrome de bronquiolitis obliterante (SBO) en pacientes con trasplante pulmonarA phase II, multicentre,randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patientsEnsayo clínico de fase II, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y búsqueda de dosis para investigar la eficacia y la seguridad de 10 y 20 mg/día de Ciclosporina A Liposómica aerosolizada (L-CsA) frente a placebo aerosolizado en la prevención del síndrome de bronquiolitis obliterante (SBO) en pacientes con trasplante pulmonar Prevention of bronchiolitis obliterans syndrome in lung transplantPrevención del sindrome de bronquiolitis obliterante en transplante pulmonar
MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans
Product Name: Ciclosporina A Liposomica Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporina/ Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Ciclosporina A Liposomica Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporina / Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Solucion de cloruro de sodio Sodium Chloride Solution
Product Code: Solvente Cloruro de Sodio Sodium Chloride Solvent
Other descriptive name: Cloruro de sodio
Product Name: Solucion de Cloruro de Sodio
Product Code: Solvente de Cloruro de Sodio
Other descriptive name: Cloruro de Sodio
Pari Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
134Phase 2Belgium;Spain;Denmark;Austria;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
66EUCTR2010-018724-16-BE
(EUCTR)
15/04/201007/04/2010A prospective, open-label, pilot-study of azithromycin for lymphocytic bronchi(oli)tis after lung transplantation - Azithromycin in lymphocytic bronchi(oli)tisA prospective, open-label, pilot-study of azithromycin for lymphocytic bronchi(oli)tis after lung transplantation - Azithromycin in lymphocytic bronchi(oli)tis Lymphocytic airway inflammation (so-called Lymphocytic Bronchitis or Bronchiolitis) post-lung transplantation: evolution of airway inflammation (BAL, TBB), pulmonary function, radiology after 3 months, 6 months, 12 months and outcome 2 years (mortality, bronchiolitis obliterans syndrome) after treatment for histologic confirmed lymphocytic bronchi(oli)tis without concurrent acute allograft rejection.
MedDRA version: 12.1;Level: LLT;Classification code 10006414;Term: Bronchial biopsy abnormal
MedDRA version: 12.1;Classification code 10025041;Term: Lung biopsy abnormal
MedDRA version: 12.1;Classification code 10063078;Term: Bronchoalveolar lavage abnormal
MedDRA version: 12.1;Classification code 10049083;Term: Respiratory tract infection NOS
MedDRA version: 12.1;Classification code 10016547;Term: FEV
MedDRA version: 12.1;Classification code 10016549;Term: FEV 1 abnormal
MedDRA version: 12.1;Classification code 10016550;Term: FEV 1 decreased
MedDRA version: 12.1;Classification code 10016553;Term: FEV 1 low
MedDRA version: 12.1;Classification code 10057799;Term: Computerised tomogram thorax abnormal
MedDRA version: 12.1;Classification code 10025127;Term: Lung transplant
MedDRA version: 12.1;Classification code 10056409;Term: Heart and lung transplant
MedDRA version: 12.1;Classification code 10051604;Term: Lung transplant rejection
MedDRA version: 12.1;Classification code 10019319;Term: Heart-lung transplant rejection
MedDRA version: 12.1;Classification code 10029888;Term: Obliterative bronchiolitis
MedDRA version: 12.1;Classification code 10049202;Term: Bronchiolitis obliterans
MedDRA version: 12.1;Classification code 10050433;Term: Prophylaxis against lung transplant rejection
MedDRA version: 12.1;Level: LLTClassification c
Trade Name: Zitromax
Product Name: Zitromax
Product Code: Na
INN or Proposed INN: OTHER SOURCES
Other descriptive name: AZITHROMYCIN DIHYDRATE
KULeuven and University Hospitals Leuven (Leuven Lung Transplant Group)NULLNot RecruitingFemale: yes
Male: yes
20Phase 4Belgium
67EUCTR2008-003800-73-DK
(EUCTR)
13/04/201018/08/2009A phase II, multicentre,randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patientsA phase II, multicentre,randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients Prevention of bronchiolitis obliterans syndrome in lung transplant
MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Pari Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
134Phase 2Spain;Belgium;Austria;Denmark;Germany;United Kingdom
68NCT01334892
(ClinicalTrials.gov)
December 200911/4/2011L-CsA in the Prevention of Bronchiolitis Obliterans Syndrome (BOS) in Lung Transplant (LT) PatientsA Phase II, Multicentre, Randomised, Double-blind, Placebo Controlled Clinical Trial to Investigate the Efficacy and Safety of Aerosolised Liposomal Ciclosporin A Versus Aerosolised Placebo in the Prevention of Bronchiolitis Obliterans Syndrome in Lung Transplant PatientsBronchiolitis ObliteransDrug: Cyclosporine Inhalation SolutionPari Pharma GmbHNULLTerminated18 YearsN/ABoth130Phase 2;Phase 3Germany
69EUCTR2005-003893-46-BE
(EUCTR)
03/11/200921/10/2009AZITHROMYCIN IN BRONCHIOLITIS OBLITERANS SYNDROME - AZI001AZITHROMYCIN IN BRONCHIOLITIS OBLITERANS SYNDROME - AZI001 - Chronic rejection at 1 and 2 year post-lung transplantation- Mortality at 1 and 2 year post-lung transplantation- Acute rejection rate at 1 and 2 post-lung transplantation- Infection rate at 1 and 2 year post-lung transplantation- Evolution of airway inflammation and pulmonary function during the first and second year post-lung transplantation
MedDRA version: 12.0;Level: LLT;Classification code 10029888;Term: Obliterative bronchiolitis
MedDRA version: 12.0;Classification code 10049202;Term: Bronchiolitis obliterans
MedDRA version: 12.0;Classification code 10068805;Term: Follicular bronchiolitis
MedDRA version: 12.0;Classification code 10019319;Term: Heart-lung transplant rejection
MedDRA version: 12.0;Classification code 10025127;Term: Lung transplant
MedDRA version: 12.0;Classification code 10050433;Term: Prophylaxis against lung transplant rejection
MedDRA version: 12.0;Classification code 10050437;Term: Prophylaxis against heart and lung transplant rejection
MedDRA version: 12.0;Classification code 10051604;Term: Lung transplant rejection
MedDRA version: 12.0;Classification code 10056409;Term: Heart and lung transplant
MedDRA version: 12.0;Classification code 10016547;Term: FEV
MedDRA version: 12.0;Classification code 10016549;Term: FEV 1 abnormal
MedDRA version: 12.0;Classification code 10016550;Term: FEV 1 decreased
MedDRA version: 12.0;Classification code 10016553;Term: FEV 1 low
Trade Name: Zithromax
Product Name: Zithromax
Product Code: NA
INN or Proposed INN: AZITHROMYCIN DIHYDRATE
Other descriptive name: AZITHROMYCIN DIHYDRATE
KULeuven and University Hospitals Leuven (Leuven Lung Transplant Group)NULLNot RecruitingFemale: yes
Male: yes
80Belgium
70EUCTR2008-003800-73-GB
(EUCTR)
27/08/200907/01/2009A phase II, multicentre, randomised, double-blind, placebo controlled, clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patientsA phase II, multicentre, randomised, double-blind, placebo controlled, clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients Prevention of bronchiolitis obliterans syndrome in lung transplant
MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans
Pari Pharma GmbHNULLNot Recruiting Female: yes
Male: yes
200Phase 2Spain;Belgium;Denmark;Austria;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
71EUCTR2008-003800-73-DE
(EUCTR)
14/07/200929/12/2008A clinical trial to investigate whether a dose of 10mg or 20mg aerolised liposomal ciclosporin A (L-CsA) is safe and effective to prevent Bronchiolitis Obliterans Syndrome (BOS) in lung transplane patientsA phase II, multicentre, randomised, double-blind, placebo controlled clinical trial to investigate the efficacy and safety of 10 or 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients Prevention of bronchiolitis obliterans syndrome in lung transplant
MedDRA version: 14.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
72EUCTR2008-003800-73-AT
(EUCTR)
08/07/200911/05/2009A clinical trial to investigate whether a dose of 10mg or 20mg aerolised liposomal ciclosporin A (L-CsA) is safe and effective to prevent Bronchiolitis Obliterans Syndrome (BOS) in lung transplane patientsA phase III, multicentre, randomised, double-blind, placebo controlled clinical trial to investigate the efficacy and safety of 10 or 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients Prevention of bronchiolitis obliterans syndrome in lung transplant
MedDRA version: 14.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride Solvent
Other descriptive name: Sodium Chloride
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom
73EUCTR2008-003801-15-GB
(EUCTR)
26/02/200924/11/2010A phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patientsA phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patients Bronchiolitis Obliterans Syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride solvent
Other descriptive name: Sodium Chloride
PARIPharma GmbHNULLNot RecruitingFemale: yes
Male: yes
70Phase 2United Kingdom
74NCT00755781
(ClinicalTrials.gov)
September 200817/9/2008Study of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung TransplantationA Multi-Center, Randomized, Controlled Study to Demonstrate the Efficacy and Safety of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung TransplantationLung TransplantDrug: Cyclosporine Inhalation Solution (CIS)APT Pharmaceuticals, Inc.NULLCompleted18 YearsN/ABoth284Phase 3United States;Canada
75NCT00656058
(ClinicalTrials.gov)
June 17, 20089/4/2008Montelukast to Treat Bronchiolitis ObliteransMulti-Institutional Prospective Phase II Study of Montelukast for the Treatment of Bronchiolitis Obliterans Following Allogeneic or Autologous Stem Cell Transplantation in Children and AdultsBronchiolitis Obliterans;Chronic Graft Versus Host Disease;Leukotriene;Montelukast;Stem Cell TransplantDrug: Singulair (Montelukast Sodium)National Cancer Institute (NCI)NULLCompleted6 Years80 YearsAll25Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT01560689
(ClinicalTrials.gov)
June 200820/3/2012Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans Following Stem Cell TransplantationOpen-labeled Trial to Evaluate the Therapeutic Effects of Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans After Allogeneic Stem Cell TransplantationBronchiolitis Obliterans;Allogeneic Stem Cell TransplantationDrug: Budesonide/formoterol;Drug: PlaceboAssistance Publique - Hôpitaux de ParisNULLCompleted16 YearsN/ABoth32Phase 2France
77NCT00624754
(ClinicalTrials.gov)
March 200815/2/2008Prospective Evaluation of the Efficacy of Budesonide/Formoterol in Bronchiolitis Obliterans in AHSCTrecipientsProspective Evaluation of the Efficacy of Budesonide/Formoterol (Symbicort®) in Bronchiolitis Obliterans in Allogeneic Haematopoietic Stem Cell Transplantation (AHSCT) RecipientsObstructive Airway DiseaseDrug: Formoterol/Budesonide;Drug: lactoseAssistance Publique - Hôpitaux de ParisAstraZenecaCompleted16 YearsN/ABoth32Phase 2France
78NCT00378677
(ClinicalTrials.gov)
February 200720/9/2006Dry Powder Inhalation of Cyclosporine A in Lung Transplant Patients With Bronchiolitis Obliterans SyndromePilot Study of Cyclosporine A Dry Powder Inhalation in Lung Transplant Patients With Bronchiolitis Obliterans SyndromeLung Transplantation;Bronchiolitis ObliteransDrug: Cyclosporine A dry powder inhalation (Drug)University Medical Centre GroningenNULLRecruiting18 YearsN/ABoth7Phase 0Netherlands
79NCT00367419
(ClinicalTrials.gov)
November 200621/8/2006Use of Erythromycin in Mustard-Induced BronchiolitisLow-Dose Long-Term Prescription of Erythromycin in Mustard-Induced Bronchiolitis ObliteransBronchiolitis Obliterans;Acute Obliterating BronchiolitisDrug: ErythromycinBaqiyatallah Medical Sciences UniversityNULLCompletedN/AN/AMalePhase 4Iran, Islamic Republic of
80EUCTR2006-000485-36-GB
(EUCTR)
23/08/200618/09/2006A randomised, double blind, placebo controlled study to Assess The Effect of Antibiotic Therapy on Chronic Rejection in Human Lung Transplantation - Azithromycin StudyA randomised, double blind, placebo controlled study to Assess The Effect of Antibiotic Therapy on Chronic Rejection in Human Lung Transplantation - Azithromycin Study Post Lung Transplantation Chronic Rejection identified as bronchiolitis obliterans syndrome (BOS)Product Name: AzithromycinNewcastle upon Tyne Hospitals NHS TrustNULLNot RecruitingFemale: yes
Male: yes
64United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2004-001290-25-DE
(EUCTR)
17/08/200617/05/2006A 3-Year Randomised, Open Label, Multi-Centre Investigator Driven Study Comparing de Novo Enteric Coated Mycophenolate Sodium with Delayed Onset Everolimus, Both Arms in Combination with Cyclosporin (using C2 monitoring) and Corticosteroids for the Prevention of Bronchiolitis Obliterans Syndrome in Heart-Lung, Bilateral Lung and Single Lung Transplant Recipients. - CeMyLungsA 3-Year Randomised, Open Label, Multi-Centre Investigator Driven Study Comparing de Novo Enteric Coated Mycophenolate Sodium with Delayed Onset Everolimus, Both Arms in Combination with Cyclosporin (using C2 monitoring) and Corticosteroids for the Prevention of Bronchiolitis Obliterans Syndrome in Heart-Lung, Bilateral Lung and Single Lung Transplant Recipients. - CeMyLungs Heart-lung, bilateral lung and single lung transplant recipientsMain ICD Classification Codes:J84.1, J43-44, E84.0, Z94.2INN or Proposed INN: Everolimus
INN or Proposed INN: Everolimus
INN or Proposed INN: Enteric coated mycophenolate sodium
INN or Proposed INN: Ciclosporine A
INN or Proposed INN: Ciclosporine A
INN or Proposed INN: Ciclosporine A
St Vincent’s Hospital, Sydney, AustraliaNULLNot RecruitingFemale: yes
Male: yes
320United Kingdom;Germany;Spain
82EUCTR2004-001290-25-GB
(EUCTR)
14/09/200516/08/2005A 3-Year Randomised, Open Label, Multi-Centre Investigator Driven Study Comparing de Novo Enteric Coated Mycophenolate Sodium with Delayed Onset Everolimus, Both Arms in Combination with Cyclosporin (using C2 monitoring) and Corticosteroids for the Prevention of Bronchiolitis Obliterans Syndrome in Heart-Lung, Bilateral Lung and Single Lung Transplant Recipients. - CeMyLungA 3-Year Randomised, Open Label, Multi-Centre Investigator Driven Study Comparing de Novo Enteric Coated Mycophenolate Sodium with Delayed Onset Everolimus, Both Arms in Combination with Cyclosporin (using C2 monitoring) and Corticosteroids for the Prevention of Bronchiolitis Obliterans Syndrome in Heart-Lung, Bilateral Lung and Single Lung Transplant Recipients. - CeMyLung Heart-Lung, bilateral lung and single lung transplant recipientsICD Classification: K01-K01.9, E53.9+Z94.1, E53.9+Z94.2, E53.9+Z94.3Trade Name: Certican
Trade Name: Myfortic
St Vincent's HospitalNULLNot RecruitingFemale: yes
Male: yes
320Spain;Austria;Germany;United Kingdom
83NCT01009619
(ClinicalTrials.gov)
September 20056/11/2009Azithromycin in Bronchiolitis Obliterans SyndromeRandomized Double-blind Placebo-controlled Prevention Trial of Azithromycin in Lung Transplantation.Bronchiolitis Obliterans Syndrome;Graft Rejection;Lymphocytic Bronchiolitis;Respiratory InfectionDrug: Azithromycin;Drug: PlaceboKatholieke Universiteit LeuvenUniversity Hospital, Gasthuisberg;Fund for Scientific Research, Flanders, BelgiumCompleted18 YearsN/AAll83Phase 4Belgium
84EUCTR2004-001290-25-AT
(EUCTR)
14/07/200506/09/2005A 3-Year Randomised, Open Label, Multi-Centre Investigator Driven Study Comparing de Novo Enteric Coated Mycophenolate Sodium with Delayed Onset Everolimus, Both Arms in Combination with Cyclosporin (using C2 monitoring) and Corticosteroids for the Prevention of Bronchiolitis Obliterans Syndrome in Heart-Lung, Bilateral Lung and Single Lung Transplant Recipients. (CERL080A2415)A 3-Year Randomised, Open Label, Multi-Centre Investigator Driven Study Comparing de Novo Enteric Coated Mycophenolate Sodium with Delayed Onset Everolimus, Both Arms in Combination with Cyclosporin (using C2 monitoring) and Corticosteroids for the Prevention of Bronchiolitis Obliterans Syndrome in Heart-Lung, Bilateral Lung and Single Lung Transplant Recipients. (CERL080A2415) Patients between 18-65 years who have received either a single or bilateral lung transplant or a combined heart-lung transplant and who are suitable to receive triple immunosuppressive therapy with either mycophenolate sodium or everolimus, both arms in combination with cyclosporin and corticosteroids.Product Name: Myfortic
Product Code: ERL080
INN or Proposed INN: Mycophenolate
Trade Name: Certican 0,5 mg Tabletten
Product Name: Certican 0,5
Product Code: RAD001
INN or Proposed INN: Everolimus
Trade Name: Certican 0,75mg Tabletten
Product Name: Certican 0,75mg
Product Code: RAD001
INN or Proposed INN: Everolimus
Prof Allan Glanville, St Vincents HospitalNULLNot RecruitingFemale: yes
Male: yes
320Spain;Austria;Germany;United Kingdom
85NCT00563251
(ClinicalTrials.gov)
April 200521/11/2007Effectiveness of Azithromycin Therapy in Improvement of Symptoms and Lung Function in Patients With Bronchiolitis Obliterans After Bone Marrow TransplantationAzithromycin Therapy for Bronchiolitis Obliterans Syndrome After Allogenic Bone Marrow TransplantationBronchiolitis Obliterans;Bone Marrow TransplantationDrug: Azithromycin;Drug: Placebo tabletHospital Authority, Hong KongThe University of Hong Kong;PfizerCompleted18 YearsN/ABoth30N/AChina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT00188825
(ClinicalTrials.gov)
May 200412/9/2005Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans in Lung TransplantA Randomized, Double Blind, Placebo Controlled Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans Syndrome in Bilateral Lung and Single Lung Transplant PatientsCOPD;Emphysema;Alpha-1 Antitrypsan DeficiencyOther: placebo;Drug: basiliximabUniversity Health Network, TorontoNovartisCompleted18 Years65 YearsAll22Phase 3Canada
87NCT00141726
(ClinicalTrials.gov)
October 200330/8/2005Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell TransplantSoluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Sub-Acute Pulmonary Dysfunction Following Allogeneic Stem Cell Transplantation. A Phase II StudyLung Injury, Acute;Respiratory Distress Syndrome, Adult;Bronchiolitis ObliteransDrug: EtanerceptUniversity of Michigan Cancer CenterNULLCompleted6 YearsN/AAll34Phase 2United States
88NCT00381147
(ClinicalTrials.gov)
July 200326/9/2006Use of Clarithromycin in Mustard-Induced BronchiolitisPhase III, Randomized, Double Blind Study of Low Dose Long Term Clarithromycin Versus Placebo in Treatment of Chronic Pulmonary Lesions Due to Sulfur MustardBronchiolitis Obliterans;Acute Obliterating BronchiolitisDrug: ClarithromycinBaqiyatallah Medical Sciences UniversityNULLCompletedN/AN/AMalePhase 3Iran, Islamic Republic of
89NCT00029328
(ClinicalTrials.gov)
September 200110/1/2002Etanercept for Non-Infectious Lung Injury Following Bone Marrow TransplantationSoluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell TransplantationRespiratory Distress Syndrome, Adult;Bronchiolitis Obliterans;PneumoniaDrug: etanerceptFDA Office of Orphan Products DevelopmentNULLCompleted12 MonthsN/ABoth15Phase 1;Phase 2United States
90NCT01429844
(ClinicalTrials.gov)
January 20015/9/2011Tacrolimus Versus Cyclosporine for Immunosuppression After Lung TransplantationRandomized, Open-label, Multi-Center Study Comparing Tacrolimus With Cyclosporin, Both Arms in Combination With Mycophenolate Mofetil and Corticosteroids for Prevention of Bronchiolitis Obliterans Syndrome in Lung Transplant PatientsBronchiolitis Obliterans;ImmunosuppressionDrug: Tacrolimus;Drug: CyclosporineUniversitätsklinikum Hamburg-EppendorfNULLCompleted18 Years66 YearsBoth274Phase 3Australia;Austria;Belgium;Germany;Spain;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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PhaseCountries
91EUCTR2008-003801-15-BE
(EUCTR)
08/01/2009A phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patientsA phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patients Bronchiolitis Obliterans Syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans
Product Name: Aerolised Liposomal Ciclosporin A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, ciclosporina
Product Name: Sodium Chloride Solution
Product Code: Sodium Chloride solvent
Other descriptive name: Sodium Chloride
PARIPharma GmbHNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Belgium;United Kingdom
92EUCTR2010-022467-36-DE
(EUCTR)
22/06/2011A phase II study about interferon gamma 1b to therapy the steroid-refractory bronchiolitis obliterans after allogenic stem cell therapyA phase II study about interferon gamma 1b to therapy the steroid-refractory bronchiolitis obliterans after allogenic stem cell therapy steroid-refractory bronchiolitis obliterans
MedDRA version: 13.1;Level: PT;Classification code 10029888;Term: Obliterative bronchiolitis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Imukin
Product Name: Imukin
INN or Proposed INN: Interferon gamma-1b
Other descriptive name: INTERFERON GAMMA-1B
Freistaat BayernNULLNot RecruitingFemale: yes
Male: yes
Phase 2Germany