Chronic rejection (or Bronchiolitis Obliterans syndrome-BOS) is a major cause of mortality and morbidity after lung transplantation. Because montelukast has been shown to be of some efficacy in a similar disease (Obliterative Bronchiolitis after bone marrow transplantation), the investigators would like to test if montelukast can indeed slow down the progression of chronic rejection after lung transplantation.
* Prospective, interventional, randomized, double-blind, placebo-controlled trial. * Clinical setting (tertiary University Hospital). * Investigator-driven, no pharmaceutical sponsor. * Lung transplant recipients. * Add-on of study-drug (placebo or montelukast) to 'standard of care' * 1:1 inclusion ratio (placebo:montelukast). * Randomisation at diagnosis of chronic rejection after informed consent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
After diagnosis of fBOS every day an oral capsule with 10 mg montelukast of placebo
UZ Gasthuisberg
Leuven, Belgium
survival/retransplantation rate after diagnosis of BOS
Time frame: 1 year after diagnosis
survival/retransplantation rate at 2 years after diagnosis
Time frame: 2 years after diagnosis
Obstructive and restrictive pulmonary function evolution
Time frame: during 1 and 2 years of treatment
Bronchoalveolar lavage fluid (BAL)
BAL will be used to assess cellularity, protein and mRNA concentration and microbiology
Time frame: during 1 and 2 years of treatment
peripheral blood
peripheral blood will be used to assess C-reactive protein, protein and mRNA concentration and fibrocytes content
Time frame: during 1 and 2 years of treatment
Cytomegalovirus (CMV) and non-CMV infection rates
Time frame: during 1 and 2 years of follow up
Acute rejection and lymphocytic bronchiolitis rates
Time frame: after 1 and 2 years of treatment
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