Montelukast in Bronchiolitis Obliterans Syndrome

Lung Transplantation Clinical Trial

— MLK002  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211509
• Other study ID #: MLK002
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2010
• Last updated: March 4, 2015
• Start date: October 2010
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products (FAGG)Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis Obliterans
• Graft Rejection
• Lung Transplantation

Intervention

Drug:
• Montelukast
After diagnosis of fBOS every day an oral capsule with 10 mg montelukast of placebo

Locations

Country	Name	City	State
Belgium	UZ Gasthuisberg	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival/retransplantation rate after diagnosis of BOS		1 year after diagnosis	No
Primary	survival/retransplantation rate at 2 years after diagnosis		2 years after diagnosis	No
Secondary	Obstructive and restrictive pulmonary function evolution		during 1 and 2 years of treatment	No
Secondary	Bronchoalveolar lavage fluid (BAL)	BAL will be used to assess cellularity, protein and mRNA concentration and microbiology	during 1 and 2 years of treatment	No
Secondary	peripheral blood	peripheral blood will be used to assess C-reactive protein, protein and mRNA concentration and fibrocytes content	during 1 and 2 years of treatment	No
Secondary	Cytomegalovirus (CMV) and non-CMV infection rates		during 1 and 2 years of follow up	No
Secondary	Acute rejection and lymphocytic bronchiolitis rates		after 1 and 2 years of treatment	No