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NCT Number: NCT01211509

Montelukast in Bronchiolitis Obliterans Syndrome

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.

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Key information

Conditions

Bronchiolitis Obliterans Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Syndrome Bronchitis Graft Rejection Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Lung Transplantation Organizing Pneumonia Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UZ Gasthuisberg

Leuven, 3000, Belgium

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Montelukast

Drug

After diagnosis of fBOS every day an oral capsule with 10 mg montelukast of placebo

Other names: Montelukast TEVA

Primary outcomes

  1. survival/retransplantation rate after diagnosis of BOS

    Time frame: 1 year after diagnosis

  2. survival/retransplantation rate at 2 years after diagnosis

    Time frame: 2 years after diagnosis

Secondary outcomes

  1. Obstructive and restrictive pulmonary function evolution

    Time frame: during 1 and 2 years of treatment

  2. 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

  3. 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

  4. Cytomegalovirus (CMV) and non-CMV infection rates

    Time frame: during 1 and 2 years of follow up

  5. Acute rejection and lymphocytic bronchiolitis rates

    Time frame: after 1 and 2 years of treatment

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven

Registry information

Official study title

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

Acronym: MLK002

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Sep 29, 2010
Registry last updated
Mar 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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