Clinical trial NCT01211509: Montelukast in Bronchiolitis Obliterans Syndrome
Official title: A Randomized, Double Blind, Placebo Controlled Trial With Montelukast to Treat Bronchiolitis Obliterans Syndrome After Lung Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bronchiolitis Obliterans
Lung Transplantation
Graft Rejection
Keywords: montelukast
cysteinyl leukotriene
lung transplantation
bronchiolitis obliterans syndrome
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2010-09-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: survival/retransplantation rate after diagnosis of BOS
timeFrame: 1 year after diagnosis
measure: survival/retransplantation rate at 2 years after diagnosis
timeFrame: 2 years after diagnosis
Secondary outcomes:
measure: Obstructive and restrictive pulmonary function evolution
timeFrame: during 1 and 2 years of treatment
measure: Bronchoalveolar lavage fluid (BAL)
timeFrame: during 1 and 2 years of treatment
measure: peripheral blood
timeFrame: during 1 and 2 years of treatment
measure: Cytomegalovirus (CMV) and non-CMV infection rates
timeFrame: during 1 and 2 years of follow up
measure: Acute rejection and lymphocytic bronchiolitis rates
timeFrame: after 1 and 2 years of treatment
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
Study officials:
affiliation: UZ gasthuisberg
name: Geert M Verleden, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.