A randomized placebo-controlled double blind study to prevent BOS - VIT001

Active, not recruiting

Conditions: A study to prevent the occurence of chronic rejection after lung transplantation. Other points of investigation include lung function evolution, rate of survival, BAL cellularity, infection rate, rate of acute rejection and reflux
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 10025127Term: Lung transplant
MedDRA version: 12.1Level: LLTClassification code 10016549Term: FEV 1 abnormal
MedDRA version: 12.1Level: LLTClassification code 10016550Term: FEV 1 decreased
MedDRA version: 12.1Level: LLTClassification code 10019319Term: Heart-lung transplant rejection
MedDRA version: 12.1Level: LLTClassification code 10050433Term: Prophylaxis against lung transplant rejection
MedDRA version: 12.1Level: LLTClassification code 10056409Term: Heart and lung transplant

Registration Number: EUCTR2010-022027-30-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: Not specified

Inclusion Criteria

•Stable LTx recipients at discharge after transplantation.
•Signed informed consent
•Adult (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

•Prolonged and/or complicated ICU-course after transplantation.
•Early (<30 days post-transplant) post-operative death
•Major suture problems (airway stenosis or stent)
•Retransplantation (lung)
•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: •Prevalence of BOS (grade 1) at 2 and 3 year post-transplant;Secondary Objective: •BAL: cells (differential cell count, fibrocytes)<br> proteins (IL-17, IL-8, IL-6, LTD4), <br> microbiology<br>•Peripheral blood: CRP and fibrocytes<br>•CMV and non-CMV infection rates<br>•Acute rejection and lymphocytic bronchiolitis rates<br>•Reflux (clinical and biochemical approach)<br>;Primary end point(s): Development of chronic rejection

Secondary Outcome Measures