Montelukast in Bronchiolitis Obliterans Syndrome (MLK002)

March 4, 2015 updated by: Geert Verleden, Universitaire Ziekenhuizen KU Leuven

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Uz Gasthuisberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: montelukast sodium
Daily treatment with 10 mg montelukast after diagnosis of fibroproliferative BOS (fBOS) which is the low neutrophilic phenotype within BOS
Drug: Montelukast
After diagnosis of fBOS every day an oral capsule with 10 mg montelukast of placebo
Other Names:
  • Montelukast TEVA
Placebo Comparator: placebo
Lactose monohydricum Ph.Eur.
Drug: Montelukast
After diagnosis of fBOS every day an oral capsule with 10 mg montelukast of placebo
Other Names:
  • Montelukast TEVA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
survival/retransplantation rate after diagnosis of BOS
Time Frame: 1 year after diagnosis
1 year after diagnosis
survival/retransplantation rate at 2 years after diagnosis
Time Frame: 2 years after diagnosis
2 years after diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obstructive and restrictive pulmonary function evolution
Time Frame: during 1 and 2 years of treatment
during 1 and 2 years of treatment
Bronchoalveolar lavage fluid (BAL)
Time Frame: during 1 and 2 years of treatment
BAL will be used to assess cellularity, protein and mRNA concentration and microbiology
during 1 and 2 years of treatment
peripheral blood
Time Frame: during 1 and 2 years of treatment
peripheral blood will be used to assess C-reactive protein, protein and mRNA concentration and fibrocytes content
during 1 and 2 years of treatment
Cytomegalovirus (CMV) and non-CMV infection rates
Time Frame: during 1 and 2 years of follow up
during 1 and 2 years of follow up
Acute rejection and lymphocytic bronchiolitis rates
Time Frame: after 1 and 2 years of treatment
after 1 and 2 years of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

KU Leuven

Investigators

  • Principal Investigator: Geert M Verleden, MD, PhD, Uz Gasthuisberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

September 28, 2010

First Submitted That Met QC Criteria

September 28, 2010

First Posted (Estimate)

September 29, 2010

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MLK002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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