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

  
2 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2012-003331-32-BE
(EUCTR)
18/06/201312/11/2012A PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PRE-TRANSPLANT AND PROMPT POST-TRANSPLANT TREATMENT WITH AZITHROMYCIN TO IMPROVE EARLY ALLOGRAFT FUNCTION AND OUTCOME AFTER LUNG TRANSPLANTATIONA 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 LeuvenNULLNot RecruitingFemale: yes
Male: yes
60Phase 4Belgium
2EUCTR2010-018724-16-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