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 | EUCTR2019-002987-29-AT (EUCTR) | 23/04/2020 | 21/01/2020 | Clinical research study to investigate efficacy and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis Obliterans Syndrome after Single or Double Lung Transplantation. | An Open Label Follow-Up Study to Evaluate the Long Term Safety and Efficacy of L-CSA in Patients with a Diagnosis of CLAD-BOS after they have completed the participation to BOSTON 1 and BOSTON 2 studies. | Bronchiolitis Obliterans Syndrome in Patients post Single or post Double Lung Transplantation MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Cyclosporine A Product Code: L-CsA INN or Proposed INN: Ciclosporin (Ciclosporinium) Other descriptive name: CICLOSPORIN A Product Name: Liposomal Cyclosporine A Product Code: L-CsA INN or Proposed INN: Ciclosporin (Ciclosporinium) Other descriptive name: CICLOSPORIN A | Zambon SpA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | France;United States;Spain;Belgium;Austria;Israel;Germany;United Kingdom | ||
| 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-DE (EUCTR) | 12/02/2020 | 26/11/2019 | Clinical research study to investigate efficacy and safety of LiposomalCyclosporine A (L-CsA) in patients with Bronchiolitis Obliterans Syndromeafter Single or Double Lung Transplantation. | An Open Label Follow-Up Study to Evaluate the Long Term Safety andEfficacy of L-CSA in Patients with a Diagnosis of CLAD-BOS after they havecompleted the participation to BOSTON 1 and BOSTON 2 studies. | Bronchiolitis Obliterans Syndrome in Patients post Single or post Double Lung Transplantation MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Cyclosporine A Product Code: L-CsA INN or Proposed INN: Ciclosporin (Ciclosporinium) Other descriptive name: CICLOSPORIN A Product Name: Liposomal Cyclosporine A Product Code: L-CsA INN or Proposed INN: Ciclosporin (Ciclosporinium) Other descriptive name: CICLOSPORIN A | Zambon SpA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 3 | France;United States;Spain;Belgium;Austria;Israel;Germany;United Kingdom | ||
| 6 | NCT04107675 (ClinicalTrials.gov) | February 11, 2020 | 25/9/2019 | A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis After Hematopoietic Transplant (BOSTON-4) | A Phase IIa Multi-Center, Randomized, Single-Blind Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell Transplantation | Bronchiolitis Obliterans;GVHD, Chronic;Stem Cell Transplant Complications | Drug: Liposomal Cyclosporine A;Drug: Liposomal Placebo | Zambon SpA | NULL | Active, not recruiting | 18 Years | N/A | All | 6 | Phase 2 | France;Germany;Spain |
| 7 | 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 | ||
| 8 | EUCTR2019-000718-13-DE (EUCTR) | 17/12/2019 | 06/06/2019 | A Clinical Research Study to Investigate the Safety and Tolerability ofinhaled Liposomal Cyclosporine A (L-CsA) in Patients with BronchiolitisObliterans Syndrome after Allogeneic Hematopoietic Stem CellTransplantation. | BOSTON-4: A Phase IIa Multi-Center, Randomized, Single-Blind Safety andTolerability Study of inhaled Liposomal Cyclosporine A in BronchiolitisObliterans Syndrome Following Allogeneic Hematopoietic Stem CellTransplantation - BOSTON-4 | Bronchiolitis Obliterans Syndrome in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Cyclosporine A Product Code: L-CsA INN or Proposed INN: Ciclosporin (Ciclosporinium) Other descriptive name: CICLOSPORIN A Product Name: Liposomal Cyclosporine A Product Code: L-CsA INN or Proposed INN: Ciclosporin (Ciclosporinium) Other descriptive name: CICLOSPORIN A | Zambon SpA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | France;Spain;Germany | ||
| 9 | EUCTR2019-000718-13-FR (EUCTR) | 03/12/2019 | 25/11/2019 | 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] | 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 | France;Spain;Germany | ||
| 10 | 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] | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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 |
| 15 | 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 |
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 | ||
| 21 | 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 | |||
| 22 | 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 |
| 23 | 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 | ||
| 24 | 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 | |||
| 25 | 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 |
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | 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 | |||
| 29 | 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 |
| 30 | 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 | ||
| 31 | 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 | ||
| 32 | 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 | ||
| 33 | 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 |
| 34 | 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 | ||
| 35 | 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 | ||
| 36 | 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 | ||
| 37 | 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 | ||
| 38 | 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 |
| 39 | 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 |
| 40 | 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 | |||
| 41 | 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 | |||
| 42 | 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 | |||
| 43 | 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 |
| 44 | 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 |