Montelukast in Bronchiolitis Obliterans Syndrome

Phase 4

Completed

• Conditions: Graft Rejection; Lung Transplantation; Bronchiolitis Obliterans
• Interventions: Drug: Montelukast

• Registration Number: NCT01211509
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study First Submitted: 2010-09-28
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-29
• Study Start: 2010-10
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Montelukast	Lactose monohydricum Ph.Eur.
montelukast sodium	Montelukast	Daily treatment with 10 mg montelukast after diagnosis of fibroproliferative BOS (fBOS) which is the low neutrophilic phenotype within BOS

Primary Outcome Measures

Name	Time	Method
survival/retransplantation rate at 2 years after diagnosis	2 years after diagnosis
survival/retransplantation rate after diagnosis of BOS	1 year after diagnosis

Secondary Outcome Measures

Name	Time	Method
Obstructive and restrictive pulmonary function evolution	during 1 and 2 years of treatment
Bronchoalveolar lavage fluid (BAL)	during 1 and 2 years of treatment	BAL will be used to assess cellularity, protein and mRNA concentration and microbiology
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
Cytomegalovirus (CMV) and non-CMV infection rates	during 1 and 2 years of follow up
Acute rejection and lymphocytic bronchiolitis rates	after 1 and 2 years of treatment

Trial Locations

Locations (1)

UZ Gasthuisberg; 🇧🇪 Leuven, Belgium