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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01211509
Study type Interventional
Source Universitaire Ziekenhuizen Leuven
Contact
Status Completed
Phase Phase 4
Start date October 2010
Completion date March 2015

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