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Montelukast in Bronchiolitis Obliterans Syndrome (MLK002)

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ClinicalTrials.gov Identifier: NCT01211509
Recruitment Status : Completed
First Posted : September 29, 2010
Last Update Posted : March 5, 2015
Sponsor:
Collaborator:
Katholieke Universiteit Leuven
Information provided by (Responsible Party):
Geert Verleden, Universitaire Ziekenhuizen 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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Obliterans Lung Transplantation Graft Rejection Drug: Montelukast Phase 4

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2010
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast
U.S. FDA Resources

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 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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Geert Verleden, Prof, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01211509     History of Changes
Other Study ID Numbers: MLK002
First Posted: September 29, 2010    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: March 2015

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

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis Obliterans
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action