Montelukast in Bronchiolitis Obliterans Syndrome | RxWiki

Montelukast in Bronchiolitis Obliterans Syndrome

Overview[ - collapse ][ - ]

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	Bronchiolitis Obliterans Lung Transplantation Graft Rejection
Intervention	Drug: Montelukast
Phase	Phase 4
Sponsor	Universitaire Ziekenhuizen Leuven
Responsible Party	Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier	NCT01211509
First Received	September 28, 2010
Last Updated	October 15, 2010
Last verified	October 2010

Tracking Information[ + expand ][ + ]

First Received Date	September 28, 2010
Last Updated Date	October 15, 2010
Start Date	October 2010
Estimated Primary Completion Date	October 2015
Current 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]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief Title	Montelukast in Bronchiolitis Obliterans Syndrome
Official Title	A Randomized, Double Blind, Placebo Controlled Trial With Montelukast to Treat Bronchiolitis Obliterans Syndrome After Lung Transplantation
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.
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
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Bronchiolitis Obliterans Lung Transplantation Graft Rejection
Intervention	Drug: Montelukast After diagnosis of fBOS every day an oral capsule with 10 mg montelukast of placebo Other Names: Montelukast TEVA
Study Arm (s)	Experimental: montelukast sodium Daily treatment with 10 mg montelukast after diagnosis of fibroproliferative BOS (fBOS) which is the low neutrophilic phenotype within BOS Placebo Comparator: placebo Lactose monohydricum Ph.Eur.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	30
Estimated Completion Date	October 2015
Estimated Primary Completion Date	October 2014
Eligibility 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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Geert M Verleden, MD, PhD 1646800 geert.verleden@uzleuven.be
Location Countries	Belgium

Administrative Information[ + expand ][ + ]

NCT Number	NCT01211509
Other Study ID Numbers	MLK002
Has Data Monitoring Committee	Yes
Information Provided By	Universitaire Ziekenhuizen Leuven
Study Sponsor	Universitaire Ziekenhuizen Leuven
Collaborators	Katholieke Universiteit Leuven
Investigators	Principal Investigator: Geert M Verleden, MD, PhD UZ gasthuisberg
Verification Date	October 2010

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