228. 閉塞性細気管支炎 Bronchiolitis obliterans Clinical trials / Disease details
臨床試験数 : 97 / 薬物数 : 118 - (DrugBank : 32) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 156
| No. | 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 | EUCTR2018-003205-25-DK (EUCTR) | 15/02/2022 | 28/09/2021 | Clinical research study to investigate efficacy and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after double lung transplantation. | A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation - BOSTON-2 | Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Cyclosporine A Product Code: L-CsA INN or Proposed INN: Ciclosporin (Ciclosporinium) Other descriptive name: CICLOSPORIN A | Zambon SpA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 3 | France;United States;Spain;Belgium;Austria;Denmark;Israel;Germany;United Kingdom | ||
| 2 | NCT04655508 (ClinicalTrials.gov) | May 21, 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: Placebo;Drug: Seretide | Assistance Publique - Hôpitaux de Paris | GlaxoSmithKline | Recruiting | 6 Years | 17 Years | All | 243 | Phase 3 | France |
| 3 | 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 | Zambon SpA | NULL | Enrolling by invitation | 18 Years | N/A | All | 220 | Phase 3 | United States;Austria;Belgium;France;Germany;Israel;Spain;United Kingdom |
| 4 | 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] | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Belgium;Spain;Austria;Israel;Germany;United Kingdom | ||
| 5 | EUCTR2019-002987-29-FR (EUCTR) | 23/01/2020 | 23/01/2020 | 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 - BOSTON-3 | Bronchiolitis Obliterans Syndrome in Patients post Single or post Double Lung Transplantation MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Cyclosporine A Product Code: L-CsA INN or Proposed INN: Ciclosporin (Ciclosporinium) Other descriptive name: CICLOSPORIN A Product Name: Liposomal Cyclosporine A Product Code: L-CsA INN or Proposed INN: Ciclosporin (Ciclosporinium) Other descriptive name: CICLOSPORIN A | BREATH Therapeutics, Inc. | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | EUCTR2018-003205-25-AT (EUCTR) | 02/04/2019 | 04/12/2018 | Clinical research study to investigate efficacy and safety of LiposomalCyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndromeafter double lung transplantation. | A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trialto Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (LCsA)Inhalation Solution Delivered via the PARI Investigational eFlow®Device plus Standard of Care versus Standard of Care Alone in theTreatment of Chronic Lung Allograft Dysfunction / Bronchiolitis ObliteransSyndrome in Patients post Double Lung Transplantation - BOSTON-2 | Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndromein Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Cyclosporine A Product Code: L-CsA INN or Proposed INN: Ciclosporin (Ciclosporinium) Other descriptive name: CICLOSPORIN A | Zambon SpA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 152 | Phase 3 | United States;France;Spain;Belgium;Austria;Israel;Germany;United Kingdom | ||
| 9 | NCT03656926 (ClinicalTrials.gov) | March 29, 2019 | 30/8/2018 | A Clinical Trial to Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A Inhalation Solution in the Treatment of CLAD/Bronchiolitis Obliterans Syndrome in Patients Post Double Lung Transplant | A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered Via the PARI Investigational eFlow® Device Plus Standard of Care Versus Standard of Care Alone in the Treatment of Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndrome in Patients Post Double Lung Transplantation | Bronchiolitis Obliterans;Chronic Rejection of Lung Transplant;Lung Transplant Rejection;Lung Transplant; Complications;Lung Transplant Failure and Rejection;Chronic Lung Allograft Dysfunction | Drug: Liposomal Cyclosporine A | Zambon SpA | NULL | Recruiting | 18 Years | N/A | All | 110 | Phase 3 | United States;Austria;Belgium;France;Germany;Israel;Spain;United Kingdom |
| 10 | NCT03657342 (ClinicalTrials.gov) | March 26, 2019 | 30/8/2018 | A Clinical Trial to Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A Inhalation Solution in the Treatment of CLAD/Bronchiolitis Obliterans Syndrome in Patients Post Single Lung Transplant | A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered Via the PARI Investigational eFlow® Device Plus Standard of Care Versus Standard of Care Alone in the Treatment of Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndrome in Patients Post Single Lung Transplantation | Bronchiolitis Obliterans;Chronic Rejection of Lung Transplant;Lung Transplant Rejection;Lung Transplant; Complications;Lung Transplant Failure and Rejection;Chronic Lung Allograft Dysfunction | Drug: Liposomal Cyclosporine A | Zambon SpA | NULL | Recruiting | 18 Years | N/A | All | 110 | Phase 3 | United States;France;Germany;Israel;Spain;United Kingdom |
| 11 | EUCTR2018-003205-25-DE (EUCTR) | 04/03/2019 | 15/11/2018 | Clinical research study to investigate efficacy and safety of LiposomalCyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndromeafter double lung transplantation. | A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trialto Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (LCsA)Inhalation Solution Delivered via the PARI Investigational eFlow®Device plus Standard of Care versus Standard of Care Alone in theTreatment of Chronic Lung Allograft Dysfunction / Bronchiolitis ObliteransSyndrome in Patients post Double Lung Transplantation - BOSTON-2 | Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndromein Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Cyclosporine A Product Code: L-CsA INN or Proposed INN: Ciclosporin (Ciclosporinium) Other descriptive name: CICLOSPORIN A | Zambon SpA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 3 | France;United States;Spain;Belgium;Austria;Israel;Germany;United Kingdom | ||
| 12 | 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] | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Belgium;Spain;Austria;Israel;Germany;United Kingdom | ||
| 13 | EUCTR2018-003204-39-DE (EUCTR) | 20/02/2019 | 15/11/2018 | Clinical research study to investigate efficacy and safety of LiposomalCyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndromeafter single lung transplantation. | A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trialto Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (LCsA)Inhalation Solution Delivered via the PARI Investigational eFlow®Device plus Standard of Care versus Standard of Care Alone in theTreatment of Chronic Lung Allograft Dysfunction / Bronchiolitis ObliteransSyndrome in Patients post Single Lung Transplantation - BOSTON-1 | Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndromein Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Cyclosporine A Product Code: L-CsA INN or Proposed INN: Ciclosporin (Ciclosporinium) Other descriptive name: CICLOSPORIN A | ZAMBON SpA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | France;United States;Spain;Israel;Germany;United Kingdom | ||
| 14 | 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] | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Spain;Israel;Germany;United Kingdom | ||
| 15 | 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] | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Spain;Israel;Germany;United Kingdom | ||
| 16 | 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 |
| 17 | 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 | |||
| 18 | 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 | ||
| 19 | 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 | |||
| 20 | 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 |
| 21 | 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 | ||
| 22 | 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 |
| 23 | 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 | ||
| 24 | 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 | |||
| 25 | 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 |
| 26 | 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 |
| 27 | 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 |
| 28 | 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 |