Lung Transplantation Clinical Trial
Official title:
A Randomized, Double Blind, Placebo Controlled Trial With Montelukast to Treat Bronchiolitis Obliterans Syndrome After Lung Transplantation
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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