228. Bronchiolitis obliterans Clinical trials / Disease details


Clinical trials : 96 Drugs : 125 - (DrugBank : 34) / Drug target genes : 33 - Drug target pathways : 155

  
11 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01959100
(ClinicalTrials.gov)
February 20147/10/2013Efficacy of Azithromycin to Prevent Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell TransplantationEvaluation of the Efficacy of Azithromycin to Prevent Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell TransplantationMalignant Hematological DiseasesDrug: Azithromycin;Drug: PlaceboAssistance Publique - Hôpitaux de ParisNULLActive, not recruiting16 YearsN/AAll480Phase 3France
2EUCTR2013-000499-14-FR
(EUCTR)
30/08/201325/09/2015N/AN/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)NULLNot RecruitingFemale: yes
Male: yes
Phase 3France
3EUCTR2012-003331-32-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
4NCT01432080
(ClinicalTrials.gov)
September 20118/9/2011Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post AllotransplantDoes Increasing Immunosuppression Prevent Transplant-associated Lung-disease Triggered by Viral Respiratory Tract Infection Following Allogeneic Stem Cell Transplant? A Pilot StudyRespiratory Tract Infections;Bronchiolitis Obliterans;Cryptogenic Organizing Pneumonia;Lung Diseases, InterstitialDrug: Prednisone;Drug: Azithromycin;Drug: Montelukast;Drug: SymbicortMaisonneuve-Rosemont HospitalThe Canadian Blood and Marrow Transplant GroupTerminated18 YearsN/AAll12Phase 2Canada
5NCT01307462
(ClinicalTrials.gov)
June 20111/3/2011Targeted Therapy of Bronchiolitis Obliterans SyndromeFluticasone Propionate, Azithromycin, and Montelukast Sodium in Treating Patients With Bronchiolitis Obliterans Who Previously Underwent Stem Cell TransplantBronchiolitis ObliteransDrug: fluticasone propionate;Drug: montelukast sodium;Drug: azithromycinStephanie LeeNational Cancer Institute (NCI)Completed6 Years99 YearsAll36Phase 2United States
6NCT01327625
(ClinicalTrials.gov)
March 201131/3/2011Efficacy Study of Azithromycin-based Therapy for Bronchiolitis ObliteransA Pilot Study Evaluating the Efficacy of Azithromycin, N-acetylcystein and Inhaled Corticosteroid Combination Therapy for Bronchiolitis Obliterans After Allogeneic Hematopoietic Cell TranspantationGraft vs Host Disease;Bronchiolitis ObliteransDrug: azithromycin + N-acetylcystein + inhaled corticosteroidAsan Medical CenterNULLTerminated15 Years75 YearsBoth6N/AKorea, Republic of
7EUCTR2010-018724-16-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
8EUCTR2005-003893-46-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
9EUCTR2006-000485-36-GB
(EUCTR)
23/08/200618/09/2006A randomised, double blind, placebo controlled study to Assess The Effect of Antibiotic Therapy on Chronic Rejection in Human Lung Transplantation - Azithromycin StudyA 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: AzithromycinNewcastle upon Tyne Hospitals NHS TrustNULLNot RecruitingFemale: yes
Male: yes
64United Kingdom
10NCT01009619
(ClinicalTrials.gov)
September 20056/11/2009Azithromycin in Bronchiolitis Obliterans SyndromeRandomized Double-blind Placebo-controlled Prevention Trial of Azithromycin in Lung Transplantation.Bronchiolitis Obliterans Syndrome;Graft Rejection;Lymphocytic Bronchiolitis;Respiratory InfectionDrug: Azithromycin;Drug: PlaceboKatholieke Universiteit LeuvenUniversity Hospital, Gasthuisberg;Fund for Scientific Research, Flanders, BelgiumCompleted18 YearsN/AAll83Phase 4Belgium
11NCT00563251
(ClinicalTrials.gov)
April 200521/11/2007Effectiveness of Azithromycin Therapy in Improvement of Symptoms and Lung Function in Patients With Bronchiolitis Obliterans After Bone Marrow TransplantationAzithromycin Therapy for Bronchiolitis Obliterans Syndrome After Allogenic Bone Marrow TransplantationBronchiolitis Obliterans;Bone Marrow TransplantationDrug: Azithromycin;Drug: Placebo tabletHospital Authority, Hong KongThe University of Hong Kong;PfizerCompleted18 YearsN/ABoth30N/AChina