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 | 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 | |||
| 2 | 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 | ||
| 3 | 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 | |||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | |||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | 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 | Pari Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Belgium;Denmark;Austria;Germany;United Kingdom | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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 |