Bronchiolitis Obliterans, Graft Rejection, Lung Transplantation
Conditions
Keywords
montelukast, cysteinyl leukotriene, lung transplantation, bronchiolitis obliterans syndrome
Brief summary
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.
Detailed description
* 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.
Interventions
DRUGMontelukast
After diagnosis of fBOS every day an oral capsule with 10 mg montelukast of placebo
Sponsors
KU Leuven
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of fBOS * Signed informed consent * Age at least 18 years old at moment of transplantation * Able to take oral medication
Exclusion criteria
* Retransplantation * Previous organ transplantation * Multi organ transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| survival/retransplantation rate after diagnosis of BOS | 1 year after diagnosis |
| survival/retransplantation rate at 2 years after diagnosis | 2 years after diagnosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| peripheral blood | during 1 and 2 years of treatment | peripheral blood will be used to assess C-reactive protein, protein and mRNA concentration and fibrocytes content |
| Obstructive and restrictive pulmonary function evolution | during 1 and 2 years of treatment | — |
| Acute rejection and lymphocytic bronchiolitis rates | after 1 and 2 years of treatment | — |
| Cytomegalovirus (CMV) and non-CMV infection rates | during 1 and 2 years of follow up | — |
| Bronchoalveolar lavage fluid (BAL) | during 1 and 2 years of treatment | BAL will be used to assess cellularity, protein and mRNA concentration and microbiology |
Countries
Belgium
Outcome results
None listed