Azithromycin dihydrate (DrugBank: Azithromycin)
2 diseases| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 228 | Bronchiolitis obliterans | 2 |
| 299 | Cystic fibrosis | 1 |
| 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 | Belgium |
| 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 | EUCTR2014-003023-22-FR (EUCTR) | 22/06/2015 | Open trial with randomized withdrawal of treatment, to evaluate the efficacy of azithromycin in the treatment of bronchiectasis excluding cystic fibrosis in children (AZI-STOP study) | Open trial with randomized withdrawal of treatment, to evaluate the efficacy of azithromycin in the treatment of bronchiectasis excluding cystic fibrosis in children (AZI-STOP study) - AZI-STOP study | bronchiectasis excluding cystic fibrosis in children;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: ZITHOMAX 40 mg/ml ENFANTS Product Name: zithromax INN or Proposed INN: AZITHROMYCIN DIHYDRATE Trade Name: ZITHROMAX 250 mg Product Name: ZITHROMAX INN or Proposed INN: AZITHROMYCIN DIHYDRATE | ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | France |