AZITHROMYCIN DIHYDRATE ( DrugBank: Azithromycin )

2 diseases
告示番号疾患名（ページ内リンク）臨床試験数
228閉塞性細気管支炎2
299嚢胞性線維症1

228. 閉塞性細気管支炎

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.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2010-018724-16-BE
(EUCTR)		15/04/201007/04/2010A prospective, open-label, pilot-study of azithromycin for lymphocytic bronchi(oli)tis after lung transplantation - Azithromycin in lymphocytic bronchi(oli)tisA 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)NULLNot RecruitingFemale: yes
Male: yes		20Phase 4Belgium
2EUCTR2005-003893-46-BE
(EUCTR)		03/11/200921/10/2009AZITHROMYCIN IN BRONCHIOLITIS OBLITERANS SYNDROME - AZI001AZITHROMYCIN 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)NULLNot RecruitingFemale: yes
Male: yes		80Phase 4Belgium

299. 嚢胞性線維症

臨床試験数 : 1,696 /  薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2014-003023-22-FR
(EUCTR)		22/06/2015Open 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 MARSEILLENULLNot RecruitingFemale: yes
Male: yes		100Phase 3France