A randomized placebo-controlled double blind study to treat BOS.

Conditions: -Mortality at 1 and 2 year post diagnosis of BOS-Infection rate during BOS-Evolution of pulmonary function after diagnosis of BOS
MedDRA version: 12.1Level: LLTClassification code 10029888Term: Obliterative bronchiolitis
MedDRA version: 12.1Level: LLTClassification code 10049202Term: Bronchiolitis obliterans
MedDRA version: 12.1Level: LLTClassification code 10068805Term: Follicular bronchiolitis
MedDRA version: 12.1Level: LLTClassification code 10019319Term: Heart-lung transplant rejection
MedDRA version: 12.1Level: LLTClassification code 10025127Term: Lung transplant
MedDRA version: 12.1Level: LLTClassification code 10051604Term: Lung transplant rejection
MedDRA version: 12.1Level: LLTClassification code 10056409Term: Heart and lung transplant
MedDRA version: 12.1Level: LLTClassification code 10016547Term: FEV
MedDRA version: 12.1Level: LLTClassification code 10016549Term: FEV 1 abnormal

Registration Number: EUCTR2010-021983-14-BE

Lead Sponsor: Z Gasthuisberg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 30

Inclusion Criteria

•Diagnosis of fBOS
•Signed informed consent
•Age at least 18 years old at moment of transplantation
•Able to take oral medication

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Retransplantation
•Previous transplantation (solid organ)
•Multi-organ transplantation (lung+ other solid organ)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The survival/retransplantation rate at 1 and 2 y post-diagnosis fBOS;Secondary Objective: •Obstructive and restrictive pulmonary function evolution <br>•BAL: cells (neutrophils, lymfocytes, fibrocytes)<br> proteins (RAGE, HGF, IL8, MMP8/9, LTD4), <br> microbiology<br>•Peripheral blood: CRP and fibrocytes<br>•Acute rejection and lymphocytic bronchiolitis rates<br>•CMV and non-CMV infection rates<br>•Gastroesophageal reflux (clinical and biochemical approach);Primary end point(s): •The survival/retransplantation rate at 1 and 2 y post-diagnosis fBOS<br>•Obstructive and restrictive pulmonary function evolution <br>•BAL: cells (neutrophils, lymfocytes, fibrocytes)<br> proteins (RAGE, HGF, IL8, MMP8/9, LTD4), <br> microbiology<br>•Peripheral blood: CRP and fibrocytes<br>•Acute rejection and lymphocytic bronchiolitis rates<br>•CMV and non-CMV infection rates<br>•Gastroesophageal reflux (clinical and biochemical approach)

Secondary Outcome Measures