228. 閉塞性細気管支炎 Bronchiolitis obliterans Clinical trials / Disease details
臨床試験数 : 96 / 薬物数 : 125 - (DrugBank : 34) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 155
| 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 | NCT01959100 (ClinicalTrials.gov) | February 2014 | 7/10/2013 | Efficacy of Azithromycin to Prevent Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation | Evaluation of the Efficacy of Azithromycin to Prevent Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation | Malignant Hematological Diseases | Drug: Azithromycin;Drug: Placebo | Assistance Publique - Hôpitaux de Paris | NULL | Active, not recruiting | 16 Years | N/A | All | 480 | Phase 3 | France |
| 2 | EUCTR2013-000499-14-FR (EUCTR) | 30/08/2013 | 25/09/2015 | N/A | N/A - ALLOZITHRO | MedDRA version: 18.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855 | Trade Name: AZITHROMYCINE 250 mg Product Name: AZITHROMYCINE 250 mg INN or Proposed INN: AZITHROMYCINE | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | France | |||
| 3 | EUCTR2012-003331-32-BE (EUCTR) | 18/06/2013 | 12/11/2012 | A PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PRE-TRANSPLANT AND PROMPT POST-TRANSPLANT TREATMENT WITH AZITHROMYCIN TO IMPROVE EARLY ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATION | A PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PRE-TRANSPLANT AND PROMPT POST-TRANSPLANT TREATMENT WITH AZITHROMYCIN TO IMPROVE EARLY ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATION | EARLY LUNG ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATION MedDRA version: 14.1;Level: LLT;Classification code 10050437;Term: Prophylaxis against heart and lung transplant rejection;System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1;Classification code 10016547;Term: FEV;System Organ Class: 10022891 - Investigations MedDRA version: 14.1;Classification code 10050433;Term: Prophylaxis against lung transplant rejection;Classification code 10006414;Term: Bronchial biopsy abnormal;Classification code 10025041;Term: Lung biopsy abnormal;Classification code 10016549;Term: FEV 1 abnormal;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Level: PT;Classification code 10025127;Term: Lung transplant;Classification code 10049237;Term: Acute cellular rejection;System Organ Class: 10021428 - Immune system disorders MedDRA version: 14.1;Classification code 10066543;Term: Acute allograft rejection;Classification code 10039008;Term: Reversible airways obstruction NOS;Classification code 10019319;Term: Heart-lung transplant rejection;Level: LLTClassi;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Azithromycin (Zitromax°) Product Name: Zitromax Product Code: not applicable INN or Proposed INN: AZITHROMYCIN Other descriptive name: AZITHROMYCIN | KULeuven and University Hospitals Leuven | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 4 | Belgium | ||
| 4 | NCT01432080 (ClinicalTrials.gov) | September 2011 | 8/9/2011 | Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant | Does Increasing Immunosuppression Prevent Transplant-associated Lung-disease Triggered by Viral Respiratory Tract Infection Following Allogeneic Stem Cell Transplant? A Pilot Study | Respiratory Tract Infections;Bronchiolitis Obliterans;Cryptogenic Organizing Pneumonia;Lung Diseases, Interstitial | Drug: Prednisone;Drug: Azithromycin;Drug: Montelukast;Drug: Symbicort | Maisonneuve-Rosemont Hospital | The Canadian Blood and Marrow Transplant Group | Terminated | 18 Years | N/A | All | 12 | Phase 2 | Canada |
| 5 | NCT01307462 (ClinicalTrials.gov) | June 2011 | 1/3/2011 | Targeted Therapy of Bronchiolitis Obliterans Syndrome | Fluticasone Propionate, Azithromycin, and Montelukast Sodium in Treating Patients With Bronchiolitis Obliterans Who Previously Underwent Stem Cell Transplant | Bronchiolitis Obliterans | Drug: fluticasone propionate;Drug: montelukast sodium;Drug: azithromycin | Stephanie Lee | National Cancer Institute (NCI) | Completed | 6 Years | 99 Years | All | 36 | Phase 2 | United States |
| 6 | NCT01327625 (ClinicalTrials.gov) | March 2011 | 31/3/2011 | Efficacy Study of Azithromycin-based Therapy for Bronchiolitis Obliterans | A Pilot Study Evaluating the Efficacy of Azithromycin, N-acetylcystein and Inhaled Corticosteroid Combination Therapy for Bronchiolitis Obliterans After Allogeneic Hematopoietic Cell Transpantation | Graft vs Host Disease;Bronchiolitis Obliterans | Drug: azithromycin + N-acetylcystein + inhaled corticosteroid | Asan Medical Center | NULL | Terminated | 15 Years | 75 Years | Both | 6 | N/A | Korea, Republic of |
| 7 | EUCTR2010-018724-16-BE (EUCTR) | 15/04/2010 | 07/04/2010 | A prospective, open-label, pilot-study of azithromycin for lymphocytic bronchi(oli)tis after lung transplantation - Azithromycin in lymphocytic bronchi(oli)tis | A prospective, open-label, pilot-study of azithromycin for lymphocytic bronchi(oli)tis after lung transplantation - Azithromycin in lymphocytic bronchi(oli)tis | Lymphocytic airway inflammation (so-called Lymphocytic Bronchitis or Bronchiolitis) post-lung transplantation: evolution of airway inflammation (BAL, TBB), pulmonary function, radiology after 3 months, 6 months, 12 months and outcome 2 years (mortality, bronchiolitis obliterans syndrome) after treatment for histologic confirmed lymphocytic bronchi(oli)tis without concurrent acute allograft rejection. MedDRA version: 12.1;Level: LLT;Classification code 10006414;Term: Bronchial biopsy abnormal MedDRA version: 12.1;Classification code 10025041;Term: Lung biopsy abnormal MedDRA version: 12.1;Classification code 10063078;Term: Bronchoalveolar lavage abnormal MedDRA version: 12.1;Classification code 10049083;Term: Respiratory tract infection NOS MedDRA version: 12.1;Classification code 10016547;Term: FEV MedDRA version: 12.1;Classification code 10016549;Term: FEV 1 abnormal MedDRA version: 12.1;Classification code 10016550;Term: FEV 1 decreased MedDRA version: 12.1;Classification code 10016553;Term: FEV 1 low MedDRA version: 12.1;Classification code 10057799;Term: Computerised tomogram thorax abnormal MedDRA version: 12.1;Classification code 10025127;Term: Lung transplant MedDRA version: 12.1;Classification code 10056409;Term: Heart and lung transplant MedDRA version: 12.1;Classification code 10051604;Term: Lung transplant rejection MedDRA version: 12.1;Classification code 10019319;Term: Heart-lung transplant rejection MedDRA version: 12.1;Classification code 10029888;Term: Obliterative bronchiolitis MedDRA version: 12.1;Classification code 10049202;Term: Bronchiolitis obliterans MedDRA version: 12.1;Classification code 10050433;Term: Prophylaxis against lung transplant rejection MedDRA version: 12.1;Level: LLTClassification c | Trade Name: Zitromax Product Name: Zitromax Product Code: Na INN or Proposed INN: OTHER SOURCES Other descriptive name: AZITHROMYCIN DIHYDRATE | KULeuven and University Hospitals Leuven (Leuven Lung Transplant Group) | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | Belgium | ||
| 8 | EUCTR2005-003893-46-BE (EUCTR) | 03/11/2009 | 21/10/2009 | AZITHROMYCIN IN BRONCHIOLITIS OBLITERANS SYNDROME - AZI001 | AZITHROMYCIN IN BRONCHIOLITIS OBLITERANS SYNDROME - AZI001 | - Chronic rejection at 1 and 2 year post-lung transplantation- Mortality at 1 and 2 year post-lung transplantation- Acute rejection rate at 1 and 2 post-lung transplantation- Infection rate at 1 and 2 year post-lung transplantation- Evolution of airway inflammation and pulmonary function during the first and second year post-lung transplantation MedDRA version: 12.0;Level: LLT;Classification code 10029888;Term: Obliterative bronchiolitis MedDRA version: 12.0;Classification code 10049202;Term: Bronchiolitis obliterans MedDRA version: 12.0;Classification code 10068805;Term: Follicular bronchiolitis MedDRA version: 12.0;Classification code 10019319;Term: Heart-lung transplant rejection MedDRA version: 12.0;Classification code 10025127;Term: Lung transplant MedDRA version: 12.0;Classification code 10050433;Term: Prophylaxis against lung transplant rejection MedDRA version: 12.0;Classification code 10050437;Term: Prophylaxis against heart and lung transplant rejection MedDRA version: 12.0;Classification code 10051604;Term: Lung transplant rejection MedDRA version: 12.0;Classification code 10056409;Term: Heart and lung transplant MedDRA version: 12.0;Classification code 10016547;Term: FEV MedDRA version: 12.0;Classification code 10016549;Term: FEV 1 abnormal MedDRA version: 12.0;Classification code 10016550;Term: FEV 1 decreased MedDRA version: 12.0;Classification code 10016553;Term: FEV 1 low | Trade Name: Zithromax Product Name: Zithromax Product Code: NA INN or Proposed INN: AZITHROMYCIN DIHYDRATE Other descriptive name: AZITHROMYCIN DIHYDRATE | KULeuven and University Hospitals Leuven (Leuven Lung Transplant Group) | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 4 | Belgium | ||
| 9 | EUCTR2006-000485-36-GB (EUCTR) | 23/08/2006 | 18/09/2006 | A randomised, double blind, placebo controlled study to Assess The Effect of Antibiotic Therapy on Chronic Rejection in Human Lung Transplantation - Azithromycin Study | A randomised, double blind, placebo controlled study to Assess The Effect of Antibiotic Therapy on Chronic Rejection in Human Lung Transplantation - Azithromycin Study | Post Lung Transplantation Chronic Rejection identified as bronchiolitis obliterans syndrome (BOS) | Product Name: Azithromycin | Newcastle upon Tyne Hospitals NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 64 | United Kingdom | |||
| 10 | NCT01009619 (ClinicalTrials.gov) | September 2005 | 6/11/2009 | Azithromycin in Bronchiolitis Obliterans Syndrome | Randomized Double-blind Placebo-controlled Prevention Trial of Azithromycin in Lung Transplantation. | Bronchiolitis Obliterans Syndrome;Graft Rejection;Lymphocytic Bronchiolitis;Respiratory Infection | Drug: Azithromycin;Drug: Placebo | Katholieke Universiteit Leuven | University Hospital, Gasthuisberg;Fund for Scientific Research, Flanders, Belgium | Completed | 18 Years | N/A | All | 83 | Phase 4 | Belgium |
| 11 | NCT00563251 (ClinicalTrials.gov) | April 2005 | 21/11/2007 | Effectiveness of Azithromycin Therapy in Improvement of Symptoms and Lung Function in Patients With Bronchiolitis Obliterans After Bone Marrow Transplantation | Azithromycin Therapy for Bronchiolitis Obliterans Syndrome After Allogenic Bone Marrow Transplantation | Bronchiolitis Obliterans;Bone Marrow Transplantation | Drug: Azithromycin;Drug: Placebo tablet | Hospital Authority, Hong Kong | The University of Hong Kong;Pfizer | Completed | 18 Years | N/A | Both | 30 | N/A | China |