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Montelukast in Bronchiolitis Obliterans Syndrome (MLK002)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Katholieke Universiteit Leuven
Information provided by:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01211509
First received: September 28, 2010
Last updated: August 6, 2014
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Bronchiolitis Obliterans
Lung Transplantation
Graft Rejection
Drug: Montelukast
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled Trial With Montelukast to Treat Bronchiolitis Obliterans Syndrome After Lung Transplantation

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • survival/retransplantation rate after diagnosis of BOS [ Time Frame: 1 year after diagnosis ] [ Designated as safety issue: No ]
  • survival/retransplantation rate at 2 years after diagnosis [ Time Frame: 2 years after diagnosis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Obstructive and restrictive pulmonary function evolution [ Time Frame: during 1 and 2 years of treatment ] [ Designated as safety issue: No ]
  • Bronchoalveolar lavage fluid (BAL) [ Time Frame: during 1 and 2 years of treatment ] [ Designated as safety issue: No ]
    BAL will be used to assess cellularity, protein and mRNA concentration and microbiology

  • peripheral blood [ Time Frame: during 1 and 2 years of treatment ] [ Designated as safety issue: No ]
    peripheral blood will be used to assess C-reactive protein, protein and mRNA concentration and fibrocytes content

  • Cytomegalovirus (CMV) and non-CMV infection rates [ Time Frame: during 1 and 2 years of follow up ] [ Designated as safety issue: No ]
  • Acute rejection and lymphocytic bronchiolitis rates [ Time Frame: after 1 and 2 years of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Montelukast TEVA

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01211509

Locations
Belgium
UZ Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Katholieke Universiteit Leuven
Investigators
Principal Investigator: Geert M Verleden, MD, PhD UZ gasthuisberg
  More Information

Publications:
Responsible Party: Geert M Verleden, University Hospital Leuven and Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01211509     History of Changes
Other Study ID Numbers: MLK002
Study First Received: September 28, 2010
Last Updated: August 6, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products (FAGG)
Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
montelukast
cysteinyl leukotriene
lung transplantation
bronchiolitis obliterans syndrome

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis Obliterans
Syndrome
Bronchial Diseases
Bronchitis
Disease
Lung Diseases
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Montelukast
Anti-Asthmatic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014