228. 閉塞性細気管支炎 ［臨床試験数：57，薬物数：78（DrugBank：34），標的遺伝子数：33，標的パスウェイ数：145］
Searched query = "Bronchiolitis obliterans", "Obliterating bronchiolitis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04107675 | January 2020 | 7 October 2019 | A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell Transplant | A Phase IIa Multi-Center, Randomized, Single-Blind Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell Transplantation | Bronchiolitis Obliterans;GVHD, Chronic;Stem Cell Transplant Complications | Drug: Liposomal Cyclosporine A;Drug: Liposomal Placebo | Breath Therapeutics Inc. | Not recruiting | 18 Years | N/A | All | 24 | Phase 2 | ||
| 2 | NCT03283007 | October 2019 | 4 November 2019 | Nintedanib in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome Grade 1-2 | A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Transplant (LTx) Recipients With Bronchiolitis Obliterans Syndrome (BOS) Grade 1-2 | Lung-transplant Recipients | Drug: Nintedanib;Drug: Placebo | Assistance Publique - Hôpitaux de Paris | Recruiting | 18 Years | N/A | All | 80 | Phase 3 | France | |
| 3 | NCT03978637 | September 9, 2019 | 22 October 2019 | Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation | An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation | Bronchiolitis Obliterans Syndrome | Drug: Itacitinib | Incyte Corporation | Recruiting | 18 Years | N/A | All | 75 | Phase 1/Phase 2 | United States | |
| 4 | NCT04029636 | August 2019 | 29 July 2019 | Hyperpolarized 129Xe MRI for the Assessment of BOS With Late Onset LONIPC | Hyperpolarized 129Xe Magnetic Resonance Imaging for the Early Detection of Bronchiolitis Obliterans Syndrome (BOS) and Other Late Onset Non-infectious Pulmonary Complications (LONIPCs) Following Hematopoietic Stem Cell Transplantation | Bronchiolitis Obliterans | Other: Inhaled Hyperpolarized Xenon-129 | Hamilton Health Sciences Corporation | Not recruiting | 18 Years | 70 Years | All | 45 | N/A | Canada | |
| 5 | NCT03603899 | June 2019 | 11 February 2019 | Hp129 Xenon Imaging and BOS in Lung Transplantation | Imaging and Understanding Bronchiolitis Obliterans Syndrome (BOS) in Lung Transplantation With Hyperpolarized 129Xenon MR Lung Imaging | Bronchiolitis Obliterans | Drug: Hp 129Xenon | Children's Hospital Medical Center, Cincinnati | Not recruiting | 6 Years | N/A | All | 45 | Phase 1/Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT03674047 | April 19, 2019 | 13 May 2019 | Ruxolitinib for Bronchiolitis Obliterans Syndrome (BOS) After Allogeneic Hematopoietic Cell Transplantation (HCT) | A Phase II Study of Ruxolitinib for Bronchiolitis Obliterans Syndrome (BOS) After Allogeneic Hematopoietic Cell Transplantation (HCT) | Other Cancer | Drug: ruxolitinib | Massachusetts General Hospital | Incyte Corporation | Recruiting | 18 Years | 75 Years | All | 50 | Phase 2 | United States |
| 7 | EUCTR2018-001747-31-FR | 09/04/2019 | 30 April 2019 | A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Transplant (LTx) recipients with bronchiolitis obliterans syndrome (BOS) grade 1-2 | A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Tranplant (LTx) recipients with bronchiolitis obliterans sydrome (BOS) grade 1-2 - INFINITX BOS | Bronchiolitis Obliterating Syndrome (SBO) grade 1 or 2 in patients with pulmonary transplantation. MedDRA version: 20.0 Level: PT Classification code 10029888 Term: Obliterative bronchiolitis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: OFEV Pharmaceutical Form: Capsule INN or Proposed INN: Nintedanib Other descriptive name: Nintedanib Concentration unit: mg milligram(s) Concentration type: equal Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | Authorised | Female: yes Male: yes | 80 | Phase 3 | France | |||
| 8 | NCT03656926 | March 29, 2019 | 14 October 2019 | A Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A Inhalation Solution in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Double Lung Transplant | A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered Via the PARI Investigational eFlow® Device Plus Standard of Care Versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Double Lung Transplantation | Bronchiolitis Obliterans;Chronic Rejection of Lung Transplant;Lung Transplant Rejection;Lung Transplant; Complications;Lung Transplant Failure and Rejection | Drug: Liposomal Cyclosporine A | Breath Therapeutics Inc. | Recruiting | 18 Years | N/A | All | 110 | Phase 3 | United States;Austria;Belgium;France;Germany;Israel;Spain;United Kingdom | |
| 9 | NCT03657342 | March 26, 2019 | 14 October 2019 | A Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A Inhalation Solution in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Single Lung Transplant | A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered Via the PARI Investigational eFlow® Device Plus Standard of Care Versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Single Lung Transplantation | Bronchiolitis Obliterans;Chronic Rejection of Lung Transplant;Lung Transplant Rejection;Lung Transplant; Complications;Lung Transplant Failure and Rejection | Drug: Liposomal Cyclosporine A | Breath Therapeutics Inc. | Recruiting | 18 Years | N/A | All | 110 | Phase 3 | United States;France;Germany;Israel;Spain;United Kingdom | |
| 10 | NCT03805477 | March 20, 2019 | 8 April 2019 | Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation | Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation (HSCT)- a Multicentre Phase II Trial | Bronchiolitis Obliterans Syndrome (BOS);Bronchiolitis Obliterans (BO) | Drug: Nintedanib | University Hospital, Basel, Switzerland | Recruiting | 18 Years | N/A | All | 40 | Phase 2 | Austria;Germany;Switzerland | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2018-003205-25-ES | 01/03/2019 | 30 April 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 Pharmaceutical Form: Powder and solvent for nebuliser solution INN or Proposed INN: Ciclosporin (Ciclosporinium) CAS Number: 59865-13-3 Current Sponsor code: L-CsA Other descriptive name: CICLOSPORIN A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- | BREATH Therapeutics Inc. | Authorised | Female: yes Male: yes | 110 | Phase 3 | France;United States;Belgium;Spain;Austria;Israel;Germany;United Kingdom | |||
| 12 | EUCTR2018-003204-39-FR | 09/01/2019 | 28 February 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 Pharmaceutical Form: Powder and solvent for nebuliser solution INN or Proposed INN: Ciclosporin (Ciclosporinium) CAS Number: 59865-13-3 Current Sponsor code: L-CsA Other descriptive name: CICLOSPORIN A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- | BREATH Therapeutics Inc. | Authorised | Female: yes Male: yes | 130 | Phase 3 | United States;France;Spain;Israel;Germany;United Kingdom | |||
| 13 | NCT03315741 | March 1, 2018 | 24 June 2019 | The Safety and Tolerability of Pirfenidone for BOS After HCT | The Safety and Tolerability of Pirfenidone for Bronchiolitis Obliterans Syndrome After Hematopoietic Cell Transplantation | Bronchiolitis Obliterans;Graft Vs Host Disease | Drug: Pirfenidone 267 MG [Esbriet] | Stanford University | Genentech, Inc. | Recruiting | 18 Years | N/A | All | 30 | Phase 1 | United States |
| 14 | NCT02669251 | April 28, 2016 | 11 November 2019 | Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation | A Phase 1b/2 Study of Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation | Chronic Graft vs Host Disease;Chronic Graft-Versus-Host-Disease;Bronchiolitis Obliterans Syndrome | Drug: MPH966 | National Cancer Institute (NCI) | Recruiting | 18 Years | 99 Years | All | 34 | Phase 1/Phase 2 | United States | |
| 15 | NCT02863835 | April 2016 | 11 June 2018 | Evaluation of Electrical Impedance Tomography for the Diagnosis of Chronic Rejection in Lung Transplants Recipients | Evaluation of Electrical Impedance Tomography for the Diagnosis of Chronic Rejection in Lung Transplants Recipients | Transplantation, Heart-Lung;Chronic Lung Allograft Dysfunction;Bronchiolitis Obliterans Syndrome | Other: EIT;Other: Salbutamol nebulisation and with CPAP | Guy's and St Thomas' NHS Foundation Trust | ADIR Association | Not recruiting | 18 Years | 70 Years | All | 50 | N/A | United Kingdom |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT02262299 | May 2015 | 9 September 2019 | European Trial of Pirfenidone in BOS, A European Multi-center Study | A European Multi-center, Randomised, Double-blind Trial of Pirfenidone in Bronchiolitis-obliterans-syndrome Grade 1-3 in Lung Transplant Recipients | Disorder Related to Lung Transplantation;CLAD, Bronchiolitis Obliterans | Drug: Pirfenidone;Drug: Placebo | Rigshospitalet, Denmark | Not recruiting | 18 Years | N/A | All | 90 | Phase 2/Phase 3 | Belgium;Denmark;Germany;Netherlands;Norway;Sweden;United Kingdom | |
| 17 | NCT03072849 | April 2015 | 16 December 2017 | Early Detection and Management of Bronchiolitis Obliterans Syndrome Following Pediatric Hematopoietic Stem Cell Transplantation | Early Detection and Management of Bronchiolitis Obliterans Syndrome Following Pediatric Hematopoietic Stem Cell Transplantation | Bronchiolitis Obliterans Syndrome | Procedure: Pulmonary function testing;Drug: FAM Therapy | Ann & Robert H Lurie Children's Hospital of Chicago | Recruiting | 6 Years | 18 Years | All | 40 | N/A | United States | |
| 18 | EUCTR2014-002022-12-BE | 10/03/2015 | 2 October 2017 | European Trial of Pirfenidone in BOS (EPOS). | A European multi-centre, randomised, double-blind trial of pirfenidone in bronchiolitis-obliterans-syndrome grade 1-3 in lung transplant recipients. - EPOS Trial | Bronchiolitis Obliterans Syndrome (BOS) in patients following lung transplantation. This syndrome occurs due to rejection of the transplanted organ (s). MedDRA version: 20.0 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans System Organ Class: 100000015490 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Pirfenidone Pharmaceutical Form: Capsule, hard INN or Proposed INN: PIRFENIDONE CAS Number: 53179-13-8 Current Sponsor code: PIR Other descriptive name: 5-Methyl-1-Phenyl-2-1-(H)-Pyridone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 267- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Clinical Trials Unit, Rigshospitalet | Authorised | Female: yes Male: yes | 80 | Phase 2 | Belgium;Denmark;Netherlands;Germany;United Kingdom;Sweden | |||
| 19 | EUCTR2014-002022-12-GB | 06/01/2015 | 28 February 2019 | European Trial of Pirfenidone in BOS (EPOS). | A European multi-centre, randomised, double-blind trial of pirfenidone in bronchiolitis-obliterans-syndrome grade 1-3 in lung transplant recipients. - EPOS Trial | Bronchiolitis Obliterans Syndrome (BOS) in patients following lung transplantation. This syndrome occurs due to rejection of the transplanted organ (s). MedDRA version: 20.0 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet Product Name: Pirfenidone Pharmaceutical Form: Capsule, hard INN or Proposed INN: PIRFENIDONE CAS Number: 53179-13-8 Current Sponsor code: PIR Other descriptive name: 5-Methyl-1-Phenyl-2-1-(H)-Pyridone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 267- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Clinical Trials Unit, Rigshospitalet | Authorised | Female: yes Male: yes | 90 | Phase 2 | Belgium;Denmark;Netherlands;Germany;United Kingdom;Sweden | |||
| 20 | NCT02316392 | December 2014 | 16 December 2017 | Imaging and Understanding BOS in Lung Transplantation | Imaging and Understanding BOS in Lung Transplantation | Bronchiolitis Obliterans Syndrome | Drug: Hyperpolarized Helium-3 MRI | Children's Hospital Medical Center, Cincinnati | Not recruiting | 1 Year | 25 Years | All | 6 | N/A | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT02543073 | September 2014 | 16 December 2017 | MSC for Treatment of Interstitial Lung Disease After Allo-HSCT | Mesenchymal Stem Cell for Treatment of Interstitial Lung Disease After Allogenetic Hematopoietic Stem Cell Transplantation | Lung Diseases, Interstitial;Hematopoietic Stem Cell Transplantation;Bronchiolitis Obliterans | Biological: MSCs;Drug: AZM;Drug: Glucocorticoid | Nanfang Hospital of Southern Medical University | Sun Yat-sen University | Recruiting | 18 Years | 65 Years | All | 60 | Phase 1/Phase 2 | China |
| 22 | NCT02181712 | July 2014 | 7 October 2019 | Mesenchymal Stem Cell Therapy for Lung Rejection | A Pilot Study to Evaluate the Safety and Feasibility of Mesenchymal Stem Cells to Induce Remission in Lung Transplant Patients Experiencing Treatment-refractory Moderate to Severe Lung Rejection | Lung Transplant Reject;Bronchiolitis Obliterans | Biological: Mesenchymal stem cell 0.5;Biological: Mesenchymal stem cell 1.0 | Mayo Clinic | Recruiting | 18 Years | 75 Years | All | 19 | Phase 1 | United States | |
| 23 | NCT01959100 | February 2014 | 20 August 2018 | Efficacy of Azithromycin to Prevent Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation | Evaluation of the Efficacy of Azithromycin to Prevent Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation | Malignant Hematological Diseases | Drug: Azithromycin;Drug: Placebo | Assistance Publique - Hôpitaux de Paris | Not recruiting | 16 Years | N/A | All | 480 | Phase 3 | France | |
| 24 | EUCTR2013-000499-14-FR | 30/08/2013 | 8 May 2017 | N/A | N/A - ALLOZITHRO | MedDRA version: 18.0 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans System Organ Class: 100000004855 | Trade Name: AZITHROMYCINE 250 mg Product Name: AZITHROMYCINE 250 mg Pharmaceutical Form: Tablet INN or Proposed INN: AZITHROMYCINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | Not Recruiting | Female: yes Male: yes | Phase 3 | France | ||||
| 25 | EUCTR2012-003331-32-BE | 18/06/2013 | 11 June 2018 | A PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PRE-TRANSPLANT AND PROMPT POST-TRANSPLANT TREATMENT WITH AZITHROMYCIN TO IMPROVE EARLY ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATION | A PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PRE-TRANSPLANT AND PROMPT POST-TRANSPLANT TREATMENT WITH AZITHROMYCIN TO IMPROVE EARLY ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATION | EARLY LUNG ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATION MedDRA version: 14.1 Level: LLT Classification code 10050437 Term: Prophylaxis against heart and lung transplant rejection System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: LLT Classification code 10016547 Term: FEV System Organ Class: 10022891 - Investigations MedDRA version: 14.1 Level: LLT Classification code 10050433 Term: Prophylaxis against lung transplant rejection System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: LLT Classification code 10006414 Term: Bronchial biopsy abnormal System Organ Class: 10022891 - Investigations MedDRA version: 14.1 Level: LLT Classification code 10025041 Term: Lung biopsy abnormal System Organ Class: 10022891 - Investigations MedDRA version: 14.1 Level: LLT Classification code 10016549 Term: FEV 1 abnormal System Organ Class: 10022891 - Investigations MedDRA version: 14.1 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: PT Classification code 10025127 Term: Lung transplant System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: LLT Classification code 10049237 Term: Acute cellular rejection System Organ Class: 10021428 - Immune system disorders MedDRA version: 14.1 Level: LLT Classification code 10066543 Term: Acute allograft rejection System Organ Class: 10021428 - Immune system disorders MedDRA version: 14.1 Level: LLT Classification code 10039008 Term: Reversible airways obstruction NOS System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: PT Classification code 10019319 Term: Heart-lung transplant rejection System Organ Class: 10021428 - Immune system disorders MedDRA version: 14.1 Level: LLT Classi;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Azithromycin (Zitromax°) Product Name: Zitromax Product Code: not applicable Pharmaceutical Form: Syrup INN or Proposed INN: AZITHROMYCIN CAS Number: 83905-01-5 Current Sponsor code: AZI Other descriptive name: AZITHROMYCIN Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use | KULeuven and University Hospitals Leuven | Not Recruiting | Female: yes Male: yes | 60 | Phase 4 | Belgium | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | NCT01469364 | March 2013 | 19 October 2017 | 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 | Not recruiting | 18 Years | N/A | All | 30 | Phase 4 | United States |
| 27 | NCT01650545 | July 2012 | 11 June 2018 | 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 | Not recruiting | 18 Years | N/A | All | 21 | Phase 1/Phase 2 | United States | |
| 28 | NCT01273207 | March 2, 2012 | 7 October 2019 | 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) | Not recruiting | 10 Years | 80 Years | All | 6 | Phase 2 | United States | |
| 29 | NCT01439958 | February 2012 | 28 April 2015 | 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 | Not recruiting | 18 Years | 80 Years | Both | 14 | Phase 3 | Germany | |
| 30 | NCT01432080 | September 2011 | 16 December 2017 | Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant | Does Increasing Immunosuppression Prevent Transplant-associated Lung-disease Triggered by Viral Respiratory Tract Infection Following Allogeneic Stem Cell Transplant? A Pilot Study | Respiratory Tract Infections;Bronchiolitis Obliterans;Cryptogenic Organizing Pneumonia;Lung Diseases, Interstitial | Drug: Prednisone;Drug: Azithromycin;Drug: Montelukast;Drug: Symbicort | Maisonneuve-Rosemont Hospital | The Canadian Blood and Marrow Transplant Group | Not recruiting | 18 Years | N/A | All | 12 | Phase 2 | Canada |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | NCT01307462 | June 2011 | 16 December 2017 | Targeted Therapy of Bronchiolitis Obliterans Syndrome | Fluticasone Propionate, Azithromycin, and Montelukast Sodium in Treating Patients With Bronchiolitis Obliterans Who Previously Underwent Stem Cell Transplant | Bronchiolitis Obliterans | Drug: fluticasone propionate;Drug: montelukast sodium;Drug: azithromycin | Stephanie Lee | National Cancer Institute (NCI) | Not recruiting | 6 Years | 99 Years | All | 36 | Phase 2 | United States |
| 32 | NCT01327625 | March 2011 | 19 February 2015 | Efficacy Study of Azithromycin-based Therapy for Bronchiolitis Obliterans | A Pilot Study Evaluating the Efficacy of Azithromycin, N-acetylcystein and Inhaled Corticosteroid Combination Therapy for Bronchiolitis Obliterans After Allogeneic Hematopoietic Cell Transpantation | Graft vs Host Disease;Bronchiolitis Obliterans | Drug: azithromycin + N-acetylcystein + inhaled corticosteroid | Asan Medical Center | Not recruiting | 15 Years | 75 Years | Both | 6 | N/A | Korea, Republic of | |
| 33 | NCT01287078 | January 29, 2011 | 28 January 2019 | Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans | Phase II Trial of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for Treatment of Bronchiolitis Obliterans | Constrictive Bronchiolitis;Bronchiolitis Obliterans;Graft vs Host Disease;Bronchiolitis, Exudative;Bronchiolitis, Proliferative | Drug: Cyclosporine Inhalation Solution | National Heart, Lung, and Blood Institute (NHLBI) | Not recruiting | 10 Years | 80 Years | All | 25 | Phase 2 | United States | |
| 34 | NCT01211509 | October 2010 | 16 March 2015 | Montelukast in Bronchiolitis Obliterans Syndrome | A Randomized, Double Blind, Placebo Controlled Trial With Montelukast to Treat Bronchiolitis Obliterans Syndrome After Lung Transplantation | Bronchiolitis Obliterans;Lung Transplantation;Graft Rejection | Drug: Montelukast | Universitaire Ziekenhuizen Leuven | Katholieke Universiteit Leuven | Not recruiting | 18 Years | 75 Years | Both | 30 | Phase 4 | Belgium |
| 35 | NCT01212406 | October 2010 | 23 November 2015 | Vitamin D in Bronchiolitis Obliterans Syndrome | A Randomized Double Blind Placebo Controlled Trial With Vitamin D to Prevent Bronchiolitis Obliterans Syndrome After Lung Transplantation | Allograft Rejection;Lung Transplantation;Bronchiolitis Obliterans | Drug: Vitamin D | Universitaire Ziekenhuizen Leuven | Katholieke Universiteit Leuven | Not recruiting | 18 Years | N/A | Both | 100 | Phase 4 | Belgium |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | EUCTR2010-021983-14-BE | 23/09/2010 | 19 March 2012 | A randomized placebo-controlled double blind study to treat BOS. | A randomized placebo-controlled double blind study to treat BOS. | -Mortality at 1 and 2 year post diagnosis of BOS -Infection rate during BOS -Evolution of pulmonary function after diagnosis of BOS MedDRA version: 12.1 Level: LLT Classification code 10029888 Term: Obliterative bronchiolitis MedDRA version: 12.1 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans MedDRA version: 12.1 Level: LLT Classification code 10068805 Term: Follicular bronchiolitis MedDRA version: 12.1 Level: LLT Classification code 10019319 Term: Heart-lung transplant rejection MedDRA version: 12.1 Level: LLT Classification code 10025127 Term: Lung transplant MedDRA version: 12.1 Level: LLT Classification code 10051604 Term: Lung transplant rejection MedDRA version: 12.1 Level: LLT Classification code 10056409 Term: Heart and lung transplant MedDRA version: 12.1 Level: LLT Classification code 10016547 Term: FEV MedDRA version: 12.1 Level: LLT Classification code 10016549 Term: FEV 1 abnormal MedDRA version: 12.1 Level: LLT Classification code 10016550 Term: FEV 1 decreased MedDRA version: 12.1 Level: LLT Classification code 10016553 Term: FEV 1 low | Trade Name: Montelukast Teva Product Name: montelukast teva Product Code: NA Pharmaceutical Form: Capsule, hard INN or Proposed INN: MONTELUKAST SODIUM CAS Number: 151767-02-1 Current Sponsor code: RVG100911 Other descriptive name: Singulair Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | UZ Gasthuisberg | Authorised | Female: yes Male: yes | 30 | Belgium | ||||
| 37 | EUCTR2010-022027-30-BE | 23/09/2010 | 19 March 2012 | A randomized placebo-controlled double blind study to prevent BOS - VIT001 | A randomized placebo-controlled double blind study to prevent BOS - VIT001 | A study to prevent the occurence of chronic rejection after lung transplantation. Other points of investigation include lung function evolution, rate of survival, BAL cellularity, infection rate, rate of acute rejection and reflux MedDRA version: 12.1 Level: LLT Classification code 10029888 Term: Obliterative bronchiolitis MedDRA version: 12.1 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans MedDRA version: 12.1 Level: LLT Classification code 10068805 Term: Follicular bronchiolitis MedDRA version: 12.1 Level: LLT Classification code 10019319 Term: Heart-lung transplant rejection MedDRA version: 12.1 Level: LLT Classification code 10025127 Term: Lung transplant MedDRA version: 12.1 Level: LLT Classification code 10050433 Term: Prophylaxis against lung transplant rejection MedDRA version: 12.1 Level: LLT Classification code 10050437 Term: Prophylaxis against heart and lung transplant rejection MedDRA version: 12.1 Level: LLT Classification code 10051604 Term: Lung transplant rejection MedDRA version: 12.1 Level: LLT Classification code 10056409 Term: Heart and lung transplant MedDRA version: 12.1 Level: LLT Classification code 10016547 Term: FEV MedDRA version: 12.1 Level: LLT Classification code 10016549 Term: FEV 1 abnormal MedDRA version: 12.1 Level: LLT Classification code 10016550 Term: FEV 1 decreased MedDRA version: 12.1 Level: LLT Classification code 10016553 Term: FEV 1 low | Trade Name: D-Cure Product Name: D-cure Pharmaceutical Form: Oral solution INN or Proposed INN: COLECALCIFEROL CAS Number: 67-97-0 Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 25000- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | UZ Gasthuisberg | Authorised | Female: yes Male: yes | Belgium | |||||
| 38 | NCT01163786 | July 2010 | 23 April 2019 | A Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD | A Phase 2 Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD | Bronchiolitis Obliterans | Drug: Bortezomib | Northwestern University | Robert H. Lurie Cancer Center | Not recruiting | N/A | N/A | All | 20 | Phase 2 | United States |
| 39 | EUCTR2010-018724-16-BE | 15/04/2010 | 21 August 2017 | A prospective, open-label, pilot-study of azithromycin for lymphocytic bronchi(oli)tis after lung transplantation - Azithromycin in lymphocytic bronchi(oli)tis | A prospective, open-label, pilot-study of azithromycin for lymphocytic bronchi(oli)tis after lung transplantation - Azithromycin in lymphocytic bronchi(oli)tis | Lymphocytic airway inflammation (so-called Lymphocytic Bronchitis or Bronchiolitis) post-lung transplantation: evolution of airway inflammation (BAL, TBB), pulmonary function, radiology after 3 months, 6 months, 12 months and outcome 2 years (mortality, bronchiolitis obliterans syndrome) after treatment for histologic confirmed lymphocytic bronchi(oli)tis without concurrent acute allograft rejection. MedDRA version: 12.1 Level: LLT Classification code 10006414 Term: Bronchial biopsy abnormal MedDRA version: 12.1 Level: LLT Classification code 10025041 Term: Lung biopsy abnormal MedDRA version: 12.1 Level: LLT Classification code 10063078 Term: Bronchoalveolar lavage abnormal MedDRA version: 12.1 Level: LLT Classification code 10049083 Term: Respiratory tract infection NOS MedDRA version: 12.1 Level: LLT Classification code 10016547 Term: FEV MedDRA version: 12.1 Level: LLT Classification code 10016549 Term: FEV 1 abnormal MedDRA version: 12.1 Level: LLT Classification code 10016550 Term: FEV 1 decreased MedDRA version: 12.1 Level: LLT Classification code 10016553 Term: FEV 1 low MedDRA version: 12.1 Level: LLT Classification code 10057799 Term: Computerised tomogram thorax abnormal MedDRA version: 12.1 Level: LLT Classification code 10025127 Term: Lung transplant MedDRA version: 12.1 Level: LLT Classification code 10056409 Term: Heart and lung transplant MedDRA version: 12.1 Level: LLT Classification code 10051604 Term: Lung transplant rejection MedDRA version: 12.1 Level: LLT Classification code 10019319 Term: Heart-lung transplant rejection MedDRA version: 12.1 Level: LLT Classification code 10029888 Term: Obliterative bronchiolitis MedDRA version: 12.1 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans MedDRA version: 12.1 Level: LLT Classification code 10050433 Term: Prophylaxis against lung transplant rejection MedDRA version: 12.1 Level: LLT Classification c | Trade Name: Zitromax Product Name: Zitromax Product Code: Na Pharmaceutical Form: Capsule, hard INN or Proposed INN: OTHER SOURCES CAS Number: 117772700 Current Sponsor code: ZTM250 Other descriptive name: AZITHROMYCIN DIHYDRATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250-250 | KULeuven and University Hospitals Leuven (Leuven Lung Transplant Group) | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | Belgium | |||
| 40 | EUCTR2010-022467-36-DE | 7 April 2015 | A phase II study about interferon gamma 1b to therapy the steroid-refractory bronchiolitis obliterans after allogenic stem cell therapy | A phase II study about interferon gamma 1b to therapy the steroid-refractory bronchiolitis obliterans after allogenic stem cell therapy | steroid-refractory bronchiolitis obliterans MedDRA version: 13.1 Level: PT Classification code 10029888 Term: Obliterative bronchiolitis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Imukin Product Name: Imukin Pharmaceutical Form: Solution for injection INN or Proposed INN: Interferon gamma-1b CAS Number: 98059-61-1 Current Sponsor code: Imukin Other descriptive name: INTERFERON GAMMA-1B Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0,1- | Freistaat Bayern | Not Recruiting | Female: yes Male: yes | Phase 2 | Germany | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | EUCTR2005-003893-46-BE | 03/11/2009 | 7 October 2014 | AZITHROMYCIN IN BRONCHIOLITIS OBLITERANS SYNDROME - AZI001 | AZITHROMYCIN IN BRONCHIOLITIS OBLITERANS SYNDROME - AZI001 | - Chronic rejection at 1 and 2 year post-lung transplantation - Mortality at 1 and 2 year post-lung transplantation - Acute rejection rate at 1 and 2 post-lung transplantation - Infection rate at 1 and 2 year post-lung transplantation - Evolution of airway inflammation and pulmonary function during the first and second year post-lung transplantation MedDRA version: 12.0 Level: LLT Classification code 10029888 Term: Obliterative bronchiolitis MedDRA version: 12.0 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans MedDRA version: 12.0 Level: LLT Classification code 10068805 Term: Follicular bronchiolitis MedDRA version: 12.0 Level: LLT Classification code 10019319 Term: Heart-lung transplant rejection MedDRA version: 12.0 Level: LLT Classification code 10025127 Term: Lung transplant MedDRA version: 12.0 Level: LLT Classification code 10050433 Term: Prophylaxis against lung transplant rejection MedDRA version: 12.0 Level: LLT Classification code 10050437 Term: Prophylaxis against heart and lung transplant rejection MedDRA version: 12.0 Level: LLT Classification code 10051604 Term: Lung transplant rejection MedDRA version: 12.0 Level: LLT Classification code 10056409 Term: Heart and lung transplant MedDRA version: 12.0 Level: LLT Classification code 10016547 Term: FEV MedDRA version: 12.0 Level: LLT Classification code 10016549 Term: FEV 1 abnormal MedDRA version: 12.0 Level: LLT Classification code 10016550 Term: FEV 1 decreased MedDRA version: 12.0 Level: LLT Classification code 10016553 Term: FEV 1 low | Trade Name: Zithromax Product Name: Zithromax Product Code: NA Pharmaceutical Form: Capsule, hard INN or Proposed INN: AZITHROMYCIN DIHYDRATE CAS Number: 117772700 Current Sponsor code: ZTM 250 Other descriptive name: AZITHROMYCIN DIHYDRATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | KULeuven and University Hospitals Leuven (Leuven Lung Transplant Group) | Not Recruiting | Female: yes Male: yes | 80 | Belgium | ||||
| 42 | EUCTR2008-003801-15-GB | 26/02/2009 | 14 August 2012 | A phase II, 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 placebo in the treatment of bronchiolitis obliterans syndrome (BOS) in allogeneic haematopoietic 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 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in the treatment of bronchiolitis obliterans syndrome (BOS) in allogeneic haematopoietic 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 Pharmaceutical Form: Powder for nebuliser solution INN or Proposed INN: Ciclosporin CAS Number: 59865-13-3 Current Sponsor code: 081400 Other descriptive name: Ciclosporine, ciclosporina Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 4- Pharmaceutical form of the placebo: Powder for nebuliser solution Route of administration of the placebo: Inhalation use Product Name: Sodium Chloride Solution Product Code: Sodium Chloride solvent Pharmaceutical Form: Nebuliser solution Current Sponsor code: Sodium Chloride Other descriptive name: Sodium Chloride Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 0.25- | PARIPharma GmbH | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | United Kingdom | |||
| 43 | NCT00755781 | September 2008 | 19 February 2015 | 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. | Not recruiting | 18 Years | N/A | Both | 284 | Phase 3 | United States;Canada | |
| 44 | NCT00656058 | June 17, 2008 | 11 June 2018 | Montelukast to Treat Bronchiolitis Obliterans | Multi-Institutional Prospective Phase II Study of Montelukast for the Treatment of Bronchiolitis Obliterans Following Allogeneic or Autologous Stem Cell Transplantation in Children and Adults | Bronchiolitis Obliterans;Chronic Graft Versus Host Disease;Leukotriene;Montelukast;Stem Cell Transplant | Drug: Singulair (Montelukast Sodium) | National Cancer Institute (NCI) | Not recruiting | 6 Years | 80 Years | All | 25 | Phase 2 | United States | |
| 45 | NCT01560689 | June 2008 | 19 February 2015 | Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans Following Stem Cell Transplantation | Open-labeled Trial to Evaluate the Therapeutic Effects of Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans After Allogeneic Stem Cell Transplantation | Bronchiolitis Obliterans;Allogeneic Stem Cell Transplantation | Drug: Budesonide/formoterol;Drug: Placebo | Assistance Publique - Hôpitaux de Paris | Not recruiting | 16 Years | N/A | Both | 32 | Phase 2 | France | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | NCT00624754 | March 2008 | 19 February 2015 | Prospective Evaluation of the Efficacy of Budesonide/Formoterol in Bronchiolitis Obliterans in AHSCT | recipientsProspective Evaluation of the Efficacy of Budesonide/Formoterol (Symbicort®) in Bronchiolitis Obliterans in Allogeneic Haematopoietic Stem Cell Transplantation (AHSCT) Recipients | Obstructive Airway Disease | Drug: Formoterol/Budesonide;Drug: lactose | Assistance Publique - Hôpitaux de Paris | AstraZeneca | Not recruiting | 16 Years | N/A | Both | 32 | Phase 2 | France |
| 47 | EUCTR2008-003801-15-BE | 2 October 2017 | A phase II, 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 placebo in the treatment of bronchiolitis obliterans syndrome (BOS) in allogeneic haematopoietic 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 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in the treatment of bronchiolitis obliterans syndrome (BOS) in allogeneic haematopoietic 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 Pharmaceutical Form: Powder for nebuliser solution INN or Proposed INN: Ciclosporin CAS Number: 59865-13-3 Current Sponsor code: 081400 Other descriptive name: Ciclosporine, ciclosporina Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 4- Pharmaceutical form of the placebo: Powder for nebuliser solution Route of administration of the placebo: Inhalation use Product Name: Sodium Chloride Solution Product Code: Sodium Chloride solvent Pharmaceutical Form: Nebuliser solution Current Sponsor code: Sodium Chloride Other descriptive name: Sodium Chloride Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 0.25- | PARIPharma GmbH | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Belgium;United Kingdom | ||||
| 48 | NCT00378677 | February 2007 | 19 February 2015 | 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 | Recruiting | 18 Years | N/A | Both | 7 | Phase 0 | Netherlands | |
| 49 | NCT00367419 | November 2006 | 19 February 2015 | Use of Erythromycin in Mustard-Induced Bronchiolitis | Low-Dose Long-Term Prescription of Erythromycin in Mustard-Induced Bronchiolitis Obliterans | Bronchiolitis Obliterans;Acute Obliterating Bronchiolitis | Drug: Erythromycin | Baqiyatallah Medical Sciences University | Not recruiting | N/A | N/A | Male | Phase 4 | Iran, Islamic Republic of | ||
| 50 | EUCTR2006-000485-36-GB | 23/08/2006 | 14 August 2012 | A randomised, double blind, placebo controlled study to Assess The Effect of Antibiotic Therapy on Chronic Rejection in Human Lung Transplantation - Azithromycin Study | A randomised, double blind, placebo controlled study to Assess The Effect of Antibiotic Therapy on Chronic Rejection in Human Lung Transplantation - Azithromycin Study | Post Lung Transplantation Chronic Rejection identified as bronchiolitis obliterans syndrome (BOS) | Product Name: Azithromycin Pharmaceutical Form: Capsule* Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Newcastle upon Tyne Hospitals NHS Trust | Not Recruiting | Female: yes Male: yes | 64 | United Kingdom | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | EUCTR2004-001290-25-GB | 14/09/2005 | 15 July 2013 | 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 recipients ICD Classification: K01-K01.9, E53.9+Z94.1, E53.9+Z94.2, E53.9+Z94.3 | Trade Name: Certican Pharmaceutical Form: Tablet Trade Name: Myfortic Pharmaceutical Form: Tablet | St Vincent's Hospital | Not Recruiting | Female: yes Male: yes | 320 | Spain;Austria;Germany;United Kingdom | ||||
| 52 | NCT00563251 | April 2005 | 19 February 2015 | Effectiveness of Azithromycin Therapy in Improvement of Symptoms and Lung Function in Patients With Bronchiolitis Obliterans After Bone Marrow Transplantation | Azithromycin Therapy for Bronchiolitis Obliterans Syndrome After Allogenic Bone Marrow Transplantation | Bronchiolitis Obliterans;Bone Marrow Transplantation | Drug: Azithromycin;Drug: Placebo tablet | Hospital Authority, Hong Kong | The University of Hong Kong;Pfizer | Not recruiting | 18 Years | N/A | Both | 30 | N/A | China |
| 53 | NCT00188825 | May 2004 | 16 December 2017 | Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans in Lung Transplant | A Randomized, Double Blind, Placebo Controlled Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans Syndrome in Bilateral Lung and Single Lung Transplant Patients | COPD;Emphysema;Alpha-1 Antitrypsan Deficiency | Other: placebo;Drug: basiliximab | University Health Network, Toronto | Novartis | Not recruiting | 18 Years | 65 Years | All | 22 | Phase 3 | Canada |
| 54 | NCT00141726 | October 2003 | 19 October 2017 | Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant | Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Sub-Acute Pulmonary Dysfunction Following Allogeneic Stem Cell Transplantation. A Phase II Study | Lung Injury, Acute;Respiratory Distress Syndrome, Adult;Bronchiolitis Obliterans | Drug: Etanercept | University of Michigan Cancer Center | Not recruiting | 6 Years | N/A | All | 34 | Phase 2 | United States | |
| 55 | NCT00381147 | July 2003 | 19 February 2015 | Use of Clarithromycin in Mustard-Induced Bronchiolitis | Phase III, Randomized, Double Blind Study of Low Dose Long Term Clarithromycin Versus Placebo in Treatment of Chronic Pulmonary Lesions Due to Sulfur Mustard | Bronchiolitis Obliterans;Acute Obliterating Bronchiolitis | Drug: Clarithromycin | Baqiyatallah Medical Sciences University | Not recruiting | N/A | N/A | Male | Phase 3 | Iran, Islamic Republic of | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | NCT00029328 | September 2001 | 7 April 2015 | Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation | Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation | Respiratory Distress Syndrome, Adult;Bronchiolitis Obliterans;Pneumonia | Drug: etanercept | FDA Office of Orphan Products Development | Not recruiting | 12 Months | N/A | Both | 15 | Phase 1/Phase 2 | United States | |
| 57 | NCT01429844 | January 2001 | 19 February 2015 | 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 | Not recruiting | 18 Years | 66 Years | Both | 274 | Phase 3 | Australia;Austria;Belgium;Germany;Spain;Switzerland |