Montelukast in Bronchiolitis Obliterans Syndrome

NCT ID: NCT01211509

Last Updated: 2015-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2015-03-31

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.

Conditions

Bronchiolitis Obliterans; Lung Transplantation; Graft Rejection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

montelukast sodium

Daily treatment with 10 mg montelukast after diagnosis of fibroproliferative BOS (fBOS) which is the low neutrophilic phenotype within BOS

Group Type: EXPERIMENTAL

Montelukast

Intervention Type: DRUG

After diagnosis of fBOS every day an oral capsule with 10 mg montelukast of placebo

placebo

Lactose monohydricum Ph.Eur.

Group Type: PLACEBO_COMPARATOR

Montelukast

Intervention Type: DRUG

After diagnosis of fBOS every day an oral capsule with 10 mg montelukast of placebo

Interventions

Montelukast

After diagnosis of fBOS every day an oral capsule with 10 mg montelukast of placebo

Intervention Type: DRUG

Other Intervention Names

Montelukast TEVA

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Geert Verleden

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geert M Verleden, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ gasthuisberg

Locations

UZ Gasthuisberg

Leuven, , Belgium

Countries

Belgium

References

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. doi: 10.1097/01.tp.0000255575.03795.df.

Reference Type: BACKGROUND

PMID: 17353777 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18827151 (View on PubMed)

Other Identifiers

MLK002

Identifier Type: -

Identifier Source: org_study_id