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.
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04655508 (ClinicalTrials.gov) | March 2021 | 10/11/2020 | Efficacy 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 Transplantation | Efficacy 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 Transplantation | Stem Cell Transplant Complications;Respiratory Disease;Bronchiolitis Obliterans | Drug: Seretide;Drug: Placebo | Assistance Publique - Hôpitaux de Paris | GlaxoSmithKline | Not yet recruiting | 6 Years | 17 Years | All | 243 | Phase 3 | France |
| 2 | NCT04239989 (ClinicalTrials.gov) | December 15, 2020 | 30/12/2019 | Itacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell Transplant | A 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 Obliterans | Drug: Itacitinib;Drug: Itacitinib Adipate | M.D. Anderson Cancer Center | National Cancer Institute (NCI) | Not yet recruiting | 18 Years | 75 Years | All | 15 | Phase 1 | United States |
| 3 | NCT03603899 (ClinicalTrials.gov) | August 2020 | 4/10/2017 | Hp129 Xenon Imaging and BOS in Lung Transplantation | Imaging and Understanding Bronchiolitis Obliterans Syndrome (BOS) in Lung Transplantation With Hyperpolarized 129Xenon MR Lung Imaging | Bronchiolitis Obliterans | Drug: Hp 129Xenon | Children's Hospital Medical Center, Cincinnati | NULL | Recruiting | 6 Years | N/A | All | 45 | Phase 1;Phase 2 | United States |
| 4 | EUCTR2019-002987-29-AT (EUCTR) | 23/04/2020 | 21/01/2020 | Clinical 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | United States;France;Spain;Belgium;Austria;Israel;Germany;United Kingdom | ||
| 5 | NCT04039347 (ClinicalTrials.gov) | March 3, 2020 | 19/7/2019 | Open-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 Transplant | A 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 Transplantation | Bronchiolitis Obliterans;Obliterative Bronchiolitis;Bronchiolitis Obliterans Syndrome | Drug: Liposomal Cyclosporine A 5 mg;Drug: Liposomal Cyclosporine A 10 mg | Breath Therapeutics Inc. | NULL | Enrolling by invitation | 18 Years | N/A | All | 220 | Phase 3 | United States;Austria;Belgium;France;Germany;Israel;Spain;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2019-002987-29-ES (EUCTR) | 28/02/2020 | 20/12/2019 | Clinical 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | France;United States;Belgium;Spain;Austria;Israel;Germany;United Kingdom | |||
| 7 | EUCTR2019-002987-29-DE (EUCTR) | 12/02/2020 | 26/11/2019 | Clinical 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | Germany;United Kingdom;France;United States;Belgium;Spain;Austria;Israel | ||
| 8 | NCT04107675 (ClinicalTrials.gov) | February 11, 2020 | 25/9/2019 | A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell Transplant | 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 | Bronchiolitis Obliterans;GVHD, Chronic;Stem Cell Transplant Complications | Drug: Liposomal Cyclosporine A;Drug: Liposomal Placebo | Breath Therapeutics Inc. | NULL | Recruiting | 18 Years | N/A | All | 24 | Phase 2 | France;Germany;Spain |
| 9 | NCT03978637 (ClinicalTrials.gov) | February 4, 2020 | 5/6/2019 | Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation | An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation | Bronchiolitis Obliterans Syndrome | Drug: Itacitinib | Incyte Corporation | NULL | Recruiting | 18 Years | N/A | All | 75 | Phase 1;Phase 2 | United States;Belgium;Canada |
| 10 | EUCTR2019-000718-13-DE (EUCTR) | 17/12/2019 | 06/06/2019 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | Spain;Germany | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2019-000718-13-ES (EUCTR) | 27/11/2019 | 05/11/2019 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | Spain | |||
| 12 | NCT03283007 (ClinicalTrials.gov) | October 30, 2019 | 6/9/2017 | Nintedanib in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome Grade 1-2 | A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Transplant (LTx) Recipients With Bronchiolitis Obliterans Syndrome (BOS) Grade 1-2 | Lung-transplant Recipients | Drug: Nintedanib;Drug: Placebo | Assistance Publique - Hôpitaux de Paris | NULL | Recruiting | 18 Years | N/A | All | 80 | Phase 3 | France |
| 13 | EUCTR2018-003204-39-GB (EUCTR) | 21/10/2019 | 14/01/2019 | Clinical 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;France;Spain;Israel;Germany;United Kingdom | ||
| 14 | EUCTR2018-003205-25-GB (EUCTR) | 11/09/2019 | 14/01/2019 | Clinical 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 3 | United States;France;Spain;Belgium;Austria;Israel;Germany;United Kingdom | ||
| 15 | NCT04029636 (ClinicalTrials.gov) | August 2019 | 7/6/2019 | Hyperpolarized 129Xe MRI for the Assessment of BOS With Late Onset LONIPC | Hyperpolarized 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 Transplantation | Bronchiolitis Obliterans | Other: Inhaled Hyperpolarized Xenon-129 | Hamilton Health Sciences Corporation | NULL | Not yet recruiting | 18 Years | 70 Years | All | 45 | Canada | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT03674047 (ClinicalTrials.gov) | April 19, 2019 | 14/9/2018 | Ruxolitinib 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 Cancer | Drug: ruxolitinib | Massachusetts General Hospital | Incyte Corporation | Recruiting | 18 Years | 75 Years | All | 50 | Phase 2 | United States |
| 17 | EUCTR2018-001747-31-FR (EUCTR) | 09/04/2019 | 28/12/2018 | 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) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 3 | France | |||
| 18 | EUCTR2018-003205-25-AT (EUCTR) | 02/04/2019 | 04/12/2018 | Clinical 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 3 | United States;France;Spain;Belgium;Austria;Israel;Germany;United Kingdom | ||
| 19 | NCT03656926 (ClinicalTrials.gov) | March 29, 2019 | 30/8/2018 | A 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 Transplant | 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 | Bronchiolitis Obliterans;Chronic Rejection of Lung Transplant;Lung Transplant Rejection;Lung Transplant; Complications;Lung Transplant Failure and Rejection | Drug: Liposomal Cyclosporine A | Breath Therapeutics Inc. | NULL | Recruiting | 18 Years | N/A | All | 110 | Phase 3 | United States;Austria;Belgium;France;Germany;Israel;Spain;United Kingdom |
| 20 | NCT03657342 (ClinicalTrials.gov) | March 26, 2019 | 30/8/2018 | A 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 Transplant | 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 | Bronchiolitis Obliterans;Chronic Rejection of Lung Transplant;Lung Transplant Rejection;Lung Transplant; Complications;Lung Transplant Failure and Rejection | Drug: Liposomal Cyclosporine A | Breath Therapeutics Inc. | NULL | Recruiting | 18 Years | N/A | All | 110 | Phase 3 | United States;France;Germany;Israel;Spain;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT03805477 (ClinicalTrials.gov) | March 20, 2019 | 8/1/2019 | Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation | Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation (HSCT)- a Multicentre Phase II Trial | Bronchiolitis Obliterans Syndrome (BOS);Bronchiolitis Obliterans (BO) | Drug: Nintedanib | University Hospital, Basel, Switzerland | NULL | Recruiting | 18 Years | N/A | All | 40 | Phase 2 | Austria;Germany;Switzerland |
| 22 | EUCTR2018-003205-25-DE (EUCTR) | 04/03/2019 | 15/11/2018 | Clinical 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 3 | United States;France;Spain;Belgium;Austria;Israel;Germany;United Kingdom | ||
| 23 | EUCTR2018-003205-25-ES (EUCTR) | 01/03/2019 | 18/01/2019 | Clinical 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 3 | France;United States;Belgium;Spain;Austria;Israel;Germany;United Kingdom | |||
| 24 | EUCTR2018-003204-39-DE (EUCTR) | 20/02/2019 | 15/11/2018 | Clinical 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;France;Spain;Israel;Germany;United Kingdom | ||
| 25 | EUCTR2018-003204-39-ES (EUCTR) | 08/02/2019 | 18/01/2019 | Clinical 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | France;United States;Spain;Israel;Germany;United Kingdom | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | EUCTR2018-003204-39-FR (EUCTR) | 09/01/2019 | 13/11/2018 | Clinical 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;France;Spain;Israel;Germany;United Kingdom | |||
| 27 | NCT03315741 (ClinicalTrials.gov) | March 1, 2018 | 5/10/2017 | The Safety and Tolerability of Pirfenidone for BOS After HCT | The Safety and Tolerability of Pirfenidone for Bronchiolitis Obliterans Syndrome After Hematopoietic Cell Transplantation | Bronchiolitis Obliterans;Graft Vs Host Disease | Drug: Pirfenidone 267 MG [Esbriet] | Stanford University | Genentech, Inc. | Recruiting | 18 Years | N/A | All | 30 | Phase 1 | United States |
| 28 | NCT02669251 (ClinicalTrials.gov) | April 28, 2016 | 29/1/2016 | Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation | A Phase 1b/2 Study of Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation | Chronic Graft vs Host Disease;Chronic Graft-Versus-Host-Disease;Bronchiolitis Obliterans Syndrome | Drug: MPH966 | National Cancer Institute (NCI) | NULL | Recruiting | 18 Years | 99 Years | All | 34 | Phase 1;Phase 2 | United States |
| 29 | NCT02863835 (ClinicalTrials.gov) | April 2016 | 4/5/2016 | Evaluation of Electrical Impedance Tomography for the Diagnosis of Chronic Rejection in Lung Transplants Recipients | Evaluation of Electrical Impedance Tomography for the Diagnosis of Chronic Rejection in Lung Transplants Recipients | Transplantation, Heart-Lung;Chronic Lung Allograft Dysfunction;Bronchiolitis Obliterans Syndrome | Other: EIT;Other: Salbutamol nebulisation and with CPAP | Guy's and St Thomas' NHS Foundation Trust | ADIR Association | Completed | 18 Years | 70 Years | All | 50 | N/A | United Kingdom |
| 30 | EUCTR2014-002022-12-SE (EUCTR) | 06/08/2015 | 15/10/2014 | European 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, Rigshospitalet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Belgium;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | EUCTR2014-002022-12-NL (EUCTR) | 13/05/2015 | 03/11/2014 | European 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, Rigshospitalet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Belgium;Denmark;Germany;Netherlands;United Kingdom;Sweden | |||
| 32 | NCT02262299 (ClinicalTrials.gov) | May 2015 | 21/9/2014 | European Trial of Pirfenidone in BOS, A European Multi-center Study | A European Multi-center, Randomised, Double-blind Trial of Pirfenidone in Bronchiolitis-obliterans-syndrome Grade 1-3 in Lung Transplant Recipients | Disorder Related to Lung Transplantation;CLAD, Bronchiolitis Obliterans | Drug: Pirfenidone;Drug: Placebo | Rigshospitalet, Denmark | NULL | Completed | 18 Years | N/A | All | 90 | Phase 2;Phase 3 | Belgium;Denmark;Germany;Netherlands;Norway;Sweden;United Kingdom |
| 33 | NCT03072849 (ClinicalTrials.gov) | April 2015 | 2/3/2017 | Early Detection and Management of Bronchiolitis Obliterans Syndrome Following Pediatric Hematopoietic Stem Cell Transplantation | Early Detection and Management of Bronchiolitis Obliterans Syndrome Following Pediatric Hematopoietic Stem Cell Transplantation | Bronchiolitis Obliterans Syndrome | Procedure: Pulmonary function testing;Drug: FAM Therapy | Ann & Robert H Lurie Children's Hospital of Chicago | NULL | Recruiting | 6 Years | 18 Years | All | 40 | N/A | United States |
| 34 | EUCTR2014-002022-12-BE (EUCTR) | 10/03/2015 | 15/10/2014 | European 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, Rigshospitalet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Belgium;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 35 | EUCTR2014-002022-12-GB (EUCTR) | 06/01/2015 | 15/10/2014 | European 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, Rigshospitalet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Belgium;Denmark;Netherlands;Germany;United Kingdom;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | EUCTR2014-002022-12-DE (EUCTR) | 30/12/2014 | 21/10/2014 | European 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, Rigshospitalet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Belgium;Denmark;Netherlands;Germany;United Kingdom;Sweden | |||
| 37 | EUCTR2014-002022-12-DK (EUCTR) | 15/12/2014 | 04/11/2014 | European 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, Rigshospitalet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Belgium;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 38 | NCT02316392 (ClinicalTrials.gov) | December 2014 | 10/12/2014 | Imaging and Understanding BOS in Lung Transplantation | Imaging and Understanding BOS in Lung Transplantation | Bronchiolitis Obliterans Syndrome | Drug: Hyperpolarized Helium-3 MRI | Children's Hospital Medical Center, Cincinnati | NULL | Completed | 1 Year | 25 Years | All | 6 | N/A | United States |
| 39 | NCT02543073 (ClinicalTrials.gov) | September 2014 | 4/9/2015 | MSC for Treatment of Interstitial Lung Disease After Allo-HSCT | Mesenchymal Stem Cell for Treatment of Interstitial Lung Disease After Allogenetic Hematopoietic Stem Cell Transplantation | Lung Diseases, Interstitial;Hematopoietic Stem Cell Transplantation;Bronchiolitis Obliterans | Biological: MSCs;Drug: AZM;Drug: Glucocorticoid | Nanfang Hospital of Southern Medical University | Sun Yat-sen University | Recruiting | 18 Years | 65 Years | All | 60 | Phase 1;Phase 2 | China |
| 40 | NCT02181712 (ClinicalTrials.gov) | July 2014 | 2/7/2014 | Mesenchymal Stem Cell Therapy for Lung Rejection | A 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 Rejection | Lung Transplant Reject;Bronchiolitis Obliterans | Biological: Mesenchymal stem cell 0.5;Biological: Mesenchymal stem cell 1.0 | Mayo Clinic | NULL | Active, not recruiting | 18 Years | 75 Years | All | 19 | Phase 1 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | NCT01959100 (ClinicalTrials.gov) | February 2014 | 7/10/2013 | Efficacy of Azithromycin to Prevent Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation | Evaluation of the Efficacy of Azithromycin to Prevent Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation | Malignant Hematological Diseases | Drug: Azithromycin;Drug: Placebo | Assistance Publique - Hôpitaux de Paris | NULL | Active, not recruiting | 16 Years | N/A | All | 480 | Phase 3 | France |
| 42 | EUCTR2013-000499-14-FR (EUCTR) | 30/08/2013 | 25/09/2015 | N/A | N/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) | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | France | |||
| 43 | EUCTR2012-003331-32-BE (EUCTR) | 18/06/2013 | 12/11/2012 | A 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 | A 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 Leuven | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 4 | Belgium | ||
| 44 | NCT01469364 (ClinicalTrials.gov) | March 2013 | 8/11/2011 | Safety 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 Transplantation | Complication of Transplanted Lung | Drug: Aztreonam Lysine for Inhalation (AZLI);Procedure: Status Post Lung Transplant | Duke University | Gilead Sciences | Completed | 18 Years | N/A | All | 30 | Phase 4 | United States |
| 45 | EUCTR2011-004304-38-ES (EUCTR) | 19/09/2012 | 22/06/2012 | An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA | 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 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | NCT01639261 (ClinicalTrials.gov) | July 2012 | 9/7/2012 | A Phase II Trial on Treatment of Steroid-refractory Bronchiolitis Obliterans With Interferon Gamma 1b After Allogeneic SCT | Eine Phase II Studie über Interferon Gamma 1b Zur Behandlung Der steroidrefraktären Bronchiolitis Obliterans Nach Allogener SZT | Steroid-refractory Bronchiolitis Obliterans | Drug: Interferon gamma 1b | University Hospital Regensburg | ClinAssess GmbH | Active, not recruiting | 18 Years | N/A | Both | 10 | Phase 2 | Germany |
| 47 | NCT01650545 (ClinicalTrials.gov) | July 2012 | 27/6/2012 | Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients | A Pilot Study to Demonstrate Efficacy and Safety of Aerosol Liposomal Cyclosporine (L-CsA) in the Treatment of Bronchiolitis Obliterans Syndrome After Lung Transplantation | Disorder Related to Lung Transplantation;Bronchiolitis Obliterans;Decreased Immunologic Activity;Chronic Rejection of Lung Transplant | Drug: Liposomal aerosol cyclosporine;Other: standard immune suppression, oral | University of Maryland, College Park | NULL | Completed | 18 Years | N/A | All | 21 | Phase 1;Phase 2 | United States |
| 48 | EUCTR2011-004304-38-GB (EUCTR) | 14/06/2012 | 09/12/2011 | An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA | 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 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom | ||
| 49 | EUCTR2011-004304-38-AT (EUCTR) | 13/03/2012 | 20/12/2011 | An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA | 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 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom | |||
| 50 | NCT01273207 (ClinicalTrials.gov) | March 2, 2012 | 7/1/2011 | Extension Study (Extended Access) of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans | Extension Study (Extended Access) of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans | Bronchiolitis Obliterans;Constructive Bronchiolitis;Graft Versus Host Disease;Bronchiolitis, Exudative;Bronchiolitis, Proliferative;Graft-Versus-Host Disease | Drug: Cyclosporine Inhalation Solution (CIS) | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 10 Years | 80 Years | All | 7 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | EUCTR2011-004304-38-BE (EUCTR) | 14/02/2012 | 15/12/2011 | An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA | 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 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | France;Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom | ||
| 52 | NCT01439958 (ClinicalTrials.gov) | February 2012 | 22/9/2011 | Long-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 Therapy | Bronchiolitis Obliterans | Drug: Inhalation | Pari Pharma GmbH | NULL | Terminated | 18 Years | 80 Years | Both | 14 | Phase 3 | Germany |
| 53 | EUCTR2011-004304-38-DK (EUCTR) | 20/01/2012 | 19/12/2011 | An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA | 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 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | France;Canada;Belgium;Spain;Austria;Denmark;Germany;United Kingdom | ||
| 54 | EUCTR2011-004304-38-DE (EUCTR) | 06/01/2012 | 28/11/2011 | An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsA | 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 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom | |||
| 55 | NCT01432080 (ClinicalTrials.gov) | September 2011 | 8/9/2011 | Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant | Does Increasing Immunosuppression Prevent Transplant-associated Lung-disease Triggered by Viral Respiratory Tract Infection Following Allogeneic Stem Cell Transplant? A Pilot Study | Respiratory Tract Infections;Bronchiolitis Obliterans;Cryptogenic Organizing Pneumonia;Lung Diseases, Interstitial | Drug: Prednisone;Drug: Azithromycin;Drug: Montelukast;Drug: Symbicort | Maisonneuve-Rosemont Hospital | The Canadian Blood and Marrow Transplant Group | Terminated | 18 Years | N/A | All | 12 | Phase 2 | Canada |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | NCT01307462 (ClinicalTrials.gov) | June 2011 | 1/3/2011 | Targeted Therapy of Bronchiolitis Obliterans Syndrome | Fluticasone Propionate, Azithromycin, and Montelukast Sodium in Treating Patients With Bronchiolitis Obliterans Who Previously Underwent Stem Cell Transplant | Bronchiolitis Obliterans | Drug: fluticasone propionate;Drug: montelukast sodium;Drug: azithromycin | Stephanie Lee | National Cancer Institute (NCI) | Completed | 6 Years | 99 Years | All | 36 | Phase 2 | United States |
| 57 | NCT01327625 (ClinicalTrials.gov) | March 2011 | 31/3/2011 | Efficacy Study of Azithromycin-based Therapy for Bronchiolitis Obliterans | A Pilot Study Evaluating the Efficacy of Azithromycin, N-acetylcystein and Inhaled Corticosteroid Combination Therapy for Bronchiolitis Obliterans After Allogeneic Hematopoietic Cell Transpantation | Graft vs Host Disease;Bronchiolitis Obliterans | Drug: azithromycin + N-acetylcystein + inhaled corticosteroid | Asan Medical Center | NULL | Terminated | 15 Years | 75 Years | Both | 6 | N/A | Korea, Republic of |
| 58 | NCT01287078 (ClinicalTrials.gov) | January 29, 2011 | 29/1/2011 | Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans Syndrome | Phase II Trial of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for Treatment of Bronchiolitis Obliterans Syndrome | Constrictive Bronchiolitis;Bronchiolitis Obliterans;Graft vs Host Disease;Bronchiolitis, Exudative;Bronchiolitis, Proliferative | Drug: Cyclosporine Inhalation Solution | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 10 Years | 80 Years | All | 25 | Phase 2 | United States |
| 59 | NCT01163786 (ClinicalTrials.gov) | October 7, 2010 | 7/7/2010 | A Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD | A Phase 2 Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD | Bronchiolitis Obliterans | Drug: Bortezomib | Northwestern University | Robert H. Lurie Cancer Center | Terminated | N/A | N/A | All | 17 | Phase 2 | United States |
| 60 | NCT01211509 (ClinicalTrials.gov) | October 2010 | 28/9/2010 | Montelukast in Bronchiolitis Obliterans Syndrome | A Randomized, Double Blind, Placebo Controlled Trial With Montelukast to Treat Bronchiolitis Obliterans Syndrome After Lung Transplantation | Bronchiolitis Obliterans;Lung Transplantation;Graft Rejection | Drug: Montelukast | Universitaire Ziekenhuizen Leuven | Katholieke Universiteit Leuven | Completed | 18 Years | 75 Years | Both | 30 | Phase 4 | Belgium |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | NCT01212406 (ClinicalTrials.gov) | October 2010 | 28/9/2010 | Vitamin D in Bronchiolitis Obliterans Syndrome | A Randomized Double Blind Placebo Controlled Trial With Vitamin D to Prevent Bronchiolitis Obliterans Syndrome After Lung Transplantation | Allograft Rejection;Lung Transplantation;Bronchiolitis Obliterans | Drug: Vitamin D | Universitaire Ziekenhuizen Leuven | Katholieke Universiteit Leuven | Completed | 18 Years | N/A | Both | 100 | Phase 4 | Belgium |
| 62 | EUCTR2010-021983-14-BE (EUCTR) | 23/09/2010 | 02/09/2010 | A 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 Gasthuisberg | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Belgium | |||
| 63 | EUCTR2010-022027-30-BE (EUCTR) | 23/09/2010 | 02/09/2010 | A randomized placebo-controlled double blind study to prevent BOS - VIT001 | A 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 Gasthuisberg | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Belgium | ||||
| 64 | EUCTR2008-003800-73-BE (EUCTR) | 14/09/2010 | 08/01/2009 | A 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 patients | A 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom | ||
| 65 | EUCTR2008-003800-73-ES (EUCTR) | 22/07/2010 | 26/05/2010 | A 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 | A 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 134 | Phase 2 | Belgium;Spain;Denmark;Austria;Germany;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | EUCTR2010-018724-16-BE (EUCTR) | 15/04/2010 | 07/04/2010 | A prospective, open-label, pilot-study of azithromycin for lymphocytic bronchi(oli)tis after lung transplantation - Azithromycin in lymphocytic bronchi(oli)tis | A 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) | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | Belgium | ||
| 67 | EUCTR2008-003800-73-DK (EUCTR) | 13/04/2010 | 18/08/2009 | A 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 | A 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 134 | Phase 2 | Spain;Belgium;Austria;Denmark;Germany;United Kingdom | ||
| 68 | NCT01334892 (ClinicalTrials.gov) | December 2009 | 11/4/2011 | L-CsA in the Prevention of Bronchiolitis Obliterans Syndrome (BOS) in Lung Transplant (LT) Patients | A 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 Patients | Bronchiolitis Obliterans | Drug: Cyclosporine Inhalation Solution | Pari Pharma GmbH | NULL | Terminated | 18 Years | N/A | Both | 130 | Phase 2;Phase 3 | Germany |
| 69 | EUCTR2005-003893-46-BE (EUCTR) | 03/11/2009 | 21/10/2009 | AZITHROMYCIN IN BRONCHIOLITIS OBLITERANS SYNDROME - AZI001 | AZITHROMYCIN 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) | NULL | Not Recruiting | Female: yes Male: yes | 80 | Belgium | |||
| 70 | EUCTR2008-003800-73-GB (EUCTR) | 27/08/2009 | 07/01/2009 | A 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 | A 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Spain;Belgium;Denmark;Austria;Germany;United Kingdom | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 71 | EUCTR2008-003800-73-DE (EUCTR) | 14/07/2009 | 29/12/2008 | A 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 patients | A 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom | ||
| 72 | EUCTR2008-003800-73-AT (EUCTR) | 08/07/2009 | 11/05/2009 | A 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 patients | A 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom | ||
| 73 | EUCTR2008-003801-15-GB (EUCTR) | 26/02/2009 | 24/11/2010 | A 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 | A 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | United Kingdom | ||
| 74 | NCT00755781 (ClinicalTrials.gov) | September 2008 | 17/9/2008 | Study of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung Transplantation | A 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 Transplantation | Lung Transplant | Drug: Cyclosporine Inhalation Solution (CIS) | APT Pharmaceuticals, Inc. | NULL | Completed | 18 Years | N/A | Both | 284 | Phase 3 | United States;Canada |
| 75 | NCT00656058 (ClinicalTrials.gov) | June 17, 2008 | 9/4/2008 | Montelukast to Treat Bronchiolitis Obliterans | Multi-Institutional Prospective Phase II Study of Montelukast for the Treatment of Bronchiolitis Obliterans Following Allogeneic or Autologous Stem Cell Transplantation in Children and Adults | Bronchiolitis Obliterans;Chronic Graft Versus Host Disease;Leukotriene;Montelukast;Stem Cell Transplant | Drug: Singulair (Montelukast Sodium) | National Cancer Institute (NCI) | NULL | Completed | 6 Years | 80 Years | All | 25 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 76 | NCT01560689 (ClinicalTrials.gov) | June 2008 | 20/3/2012 | Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans Following Stem Cell Transplantation | Open-labeled Trial to Evaluate the Therapeutic Effects of Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans After Allogeneic Stem Cell Transplantation | Bronchiolitis Obliterans;Allogeneic Stem Cell Transplantation | Drug: Budesonide/formoterol;Drug: Placebo | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 16 Years | N/A | Both | 32 | Phase 2 | France |
| 77 | NCT00624754 (ClinicalTrials.gov) | March 2008 | 15/2/2008 | Prospective Evaluation of the Efficacy of Budesonide/Formoterol in Bronchiolitis Obliterans in AHSCT | recipientsProspective Evaluation of the Efficacy of Budesonide/Formoterol (Symbicort®) in Bronchiolitis Obliterans in Allogeneic Haematopoietic Stem Cell Transplantation (AHSCT) Recipients | Obstructive Airway Disease | Drug: Formoterol/Budesonide;Drug: lactose | Assistance Publique - Hôpitaux de Paris | AstraZeneca | Completed | 16 Years | N/A | Both | 32 | Phase 2 | France |
| 78 | NCT00378677 (ClinicalTrials.gov) | February 2007 | 20/9/2006 | Dry Powder Inhalation of Cyclosporine A in Lung Transplant Patients With Bronchiolitis Obliterans Syndrome | Pilot Study of Cyclosporine A Dry Powder Inhalation in Lung Transplant Patients With Bronchiolitis Obliterans Syndrome | Lung Transplantation;Bronchiolitis Obliterans | Drug: Cyclosporine A dry powder inhalation (Drug) | University Medical Centre Groningen | NULL | Recruiting | 18 Years | N/A | Both | 7 | Phase 0 | Netherlands |
| 79 | NCT00367419 (ClinicalTrials.gov) | November 2006 | 21/8/2006 | Use of Erythromycin in Mustard-Induced Bronchiolitis | Low-Dose Long-Term Prescription of Erythromycin in Mustard-Induced Bronchiolitis Obliterans | Bronchiolitis Obliterans;Acute Obliterating Bronchiolitis | Drug: Erythromycin | Baqiyatallah Medical Sciences University | NULL | Completed | N/A | N/A | Male | Phase 4 | Iran, Islamic Republic of | |
| 80 | EUCTR2006-000485-36-GB (EUCTR) | 23/08/2006 | 18/09/2006 | A randomised, double blind, placebo controlled study to Assess The Effect of Antibiotic Therapy on Chronic Rejection in Human Lung Transplantation - Azithromycin Study | A 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: Azithromycin | Newcastle upon Tyne Hospitals NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 64 | United Kingdom | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 81 | EUCTR2004-001290-25-DE (EUCTR) | 17/08/2006 | 17/05/2006 | 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. - CeMyLungs | 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. - CeMyLungs | Heart-lung, bilateral lung and single lung transplant recipientsMain ICD Classification Codes:J84.1, J43-44, E84.0, Z94.2 | INN 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, Australia | NULL | Not Recruiting | Female: yes Male: yes | 320 | United Kingdom;Germany;Spain | |||
| 82 | EUCTR2004-001290-25-GB (EUCTR) | 14/09/2005 | 16/08/2005 | 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. - CeMyLung | 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. - CeMyLung | Heart-Lung, bilateral lung and single lung transplant recipientsICD Classification: K01-K01.9, E53.9+Z94.1, E53.9+Z94.2, E53.9+Z94.3 | Trade Name: Certican Trade Name: Myfortic | St Vincent's Hospital | NULL | Not Recruiting | Female: yes Male: yes | 320 | Spain;Austria;Germany;United Kingdom | |||
| 83 | NCT01009619 (ClinicalTrials.gov) | September 2005 | 6/11/2009 | Azithromycin in Bronchiolitis Obliterans Syndrome | Randomized Double-blind Placebo-controlled Prevention Trial of Azithromycin in Lung Transplantation. | Bronchiolitis Obliterans Syndrome;Graft Rejection;Lymphocytic Bronchiolitis;Respiratory Infection | Drug: Azithromycin;Drug: Placebo | Katholieke Universiteit Leuven | University Hospital, Gasthuisberg;Fund for Scientific Research, Flanders, Belgium | Completed | 18 Years | N/A | All | 83 | Phase 4 | Belgium |
| 84 | EUCTR2004-001290-25-AT (EUCTR) | 14/07/2005 | 06/09/2005 | 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) | 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 Hospital | NULL | Not Recruiting | Female: yes Male: yes | 320 | Spain;Austria;Germany;United Kingdom | |||
| 85 | NCT00563251 (ClinicalTrials.gov) | April 2005 | 21/11/2007 | Effectiveness of Azithromycin Therapy in Improvement of Symptoms and Lung Function in Patients With Bronchiolitis Obliterans After Bone Marrow Transplantation | Azithromycin Therapy for Bronchiolitis Obliterans Syndrome After Allogenic Bone Marrow Transplantation | Bronchiolitis Obliterans;Bone Marrow Transplantation | Drug: Azithromycin;Drug: Placebo tablet | Hospital Authority, Hong Kong | The University of Hong Kong;Pfizer | Completed | 18 Years | N/A | Both | 30 | N/A | China |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 86 | NCT00188825 (ClinicalTrials.gov) | May 2004 | 12/9/2005 | Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans in Lung Transplant | A 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 Patients | COPD;Emphysema;Alpha-1 Antitrypsan Deficiency | Other: placebo;Drug: basiliximab | University Health Network, Toronto | Novartis | Completed | 18 Years | 65 Years | All | 22 | Phase 3 | Canada |
| 87 | NCT00141726 (ClinicalTrials.gov) | October 2003 | 30/8/2005 | Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant | Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Sub-Acute Pulmonary Dysfunction Following Allogeneic Stem Cell Transplantation. A Phase II Study | Lung Injury, Acute;Respiratory Distress Syndrome, Adult;Bronchiolitis Obliterans | Drug: Etanercept | University of Michigan Cancer Center | NULL | Completed | 6 Years | N/A | All | 34 | Phase 2 | United States |
| 88 | NCT00381147 (ClinicalTrials.gov) | July 2003 | 26/9/2006 | Use of Clarithromycin in Mustard-Induced Bronchiolitis | Phase III, Randomized, Double Blind Study of Low Dose Long Term Clarithromycin Versus Placebo in Treatment of Chronic Pulmonary Lesions Due to Sulfur Mustard | Bronchiolitis Obliterans;Acute Obliterating Bronchiolitis | Drug: Clarithromycin | Baqiyatallah Medical Sciences University | NULL | Completed | N/A | N/A | Male | Phase 3 | Iran, Islamic Republic of | |
| 89 | NCT00029328 (ClinicalTrials.gov) | September 2001 | 10/1/2002 | Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation | Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation | Respiratory Distress Syndrome, Adult;Bronchiolitis Obliterans;Pneumonia | Drug: etanercept | FDA Office of Orphan Products Development | NULL | Completed | 12 Months | N/A | Both | 15 | Phase 1;Phase 2 | United States |
| 90 | NCT01429844 (ClinicalTrials.gov) | January 2001 | 5/9/2011 | Tacrolimus Versus Cyclosporine for Immunosuppression After Lung Transplantation | Randomized, 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 Patients | Bronchiolitis Obliterans;Immunosuppression | Drug: Tacrolimus;Drug: Cyclosporine | Universitätsklinikum Hamburg-Eppendorf | NULL | Completed | 18 Years | 66 Years | Both | 274 | Phase 3 | Australia;Austria;Belgium;Germany;Spain;Switzerland |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 91 | EUCTR2008-003801-15-BE (EUCTR) | 08/01/2009 | A 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 | A 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Belgium;United Kingdom | |||
| 92 | EUCTR2010-022467-36-DE (EUCTR) | 22/06/2011 | A phase II study about interferon gamma 1b to therapy the steroid-refractory bronchiolitis obliterans after allogenic stem cell therapy | A 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 Bayern | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Germany |