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 | 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 | ||
| 2 | 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 |