MLK002: Montelukast in Bronchiolitis Obliterans Syndrome
Study Details
Study Description
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 |
|---|---|---|
| Phase 4 |
Detailed Description
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Prospective, interventional, randomized, double-blind, placebo-controlled trial.
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Clinical setting (tertiary University Hospital).
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Investigator-driven, no pharmaceutical sponsor.
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Lung transplant recipients.
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Add-on of study-drug (placebo or montelukast) to 'standard of care'
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1:1 inclusion ratio (placebo:montelukast).
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Randomisation at diagnosis of chronic rejection after informed consent.
Study Design
Arms and Interventions
| 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:
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| 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:
|
Outcome Measures
Primary Outcome Measures
- survival/retransplantation rate after diagnosis of BOS [1 year after diagnosis]
- survival/retransplantation rate at 2 years after diagnosis [2 years after diagnosis]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of fBOS
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Signed informed consent
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Age at least 18 years old at moment of transplantation
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Able to take oral medication
Exclusion Criteria:
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Retransplantation
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Previous organ transplantation
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Multi organ transplantation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UZ Gasthuisberg | Leuven | Belgium | 3000 |
Sponsors and Collaborators
- Universitaire Ziekenhuizen Leuven
- KU Leuven
Investigators
- Principal Investigator: Geert M Verleden, MD, PhD, UZ gasthuisberg
Study Documents (Full-Text)
None provided.More Information
Publications
- Or R, Gesundheit B, Resnick I, Bitan M, Avraham A, Avgil M, Sacks Z, Shapira MY. Sparing effect by montelukast treatment for chronic graft versus host disease: a pilot study. Transplantation. 2007 Mar 15;83(5):577-81.
- Vanaudenaerde BM, Meyts I, Vos R, Geudens N, De Wever W, Verbeken EK, Van Raemdonck DE, Dupont LJ, Verleden GM. A dichotomy in bronchiolitis obliterans syndrome after lung transplantation revealed by azithromycin therapy. Eur Respir J. 2008 Oct;32(4):832-43. doi: 10.1183/09031936.00134307. Review.
- MLK002