NCT01211509

Montelukast in Bronchiolitis Obliterans Syndrome

A Randomized, Double Blind, Placebo Controlled Trial With Montelukast to Treat Bronchiolitis Obliterans Syndrome After Lung Transplantation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bronchiolitis Obliterans
• Lung Transplantation
• Graft Rejection

Interventions

Type	Name	Description
DRUG	Montelukast	After diagnosis of fBOS every day an oral capsule with 10 mg montelukast of placebo

Timeline

• Start date: 2010-10-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2010-09-29
• Last updated: 2015-03-05

Locations

1 site across 1 country: Belgium