Montelukast in Bronchiolitis Obliterans Syndrome (MLK002)

Universitaire Ziekenhuizen KU Leuven

Status and phase: Completed; Phase 4

Conditions: Bronchiolitis Obliterans; Graft Rejection; Lung Transplantation

Treatments: Drug: Montelukast

Study type: Interventional

Funder types: Other

Identifiers

NCT01211509

MLK002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

montelukast sodium

Experimental group

Description:

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

Treatment:

Drug: Montelukast

placebo

Placebo Comparator group

Description:

Lactose monohydricum Ph.Eur.

Treatment:

Drug: Montelukast