Montelukast for Patients With Obstructive Sleep Apnea Syndrome
Impact of Blocked Cysteinyl Leukotriene Pathway on Endothelial Function in Patients With Obstructive Sleep Apnea Syndrome: Multicenter Randomized Placebo Controlled Crossover Trial
  • Phase

    Phase 3
  • Study Type

  • Status

  • Study Participants

This study compares the effect of Montelukast vs Placebo on Flow Mediated Dilatation of the Brachial Artery (FMD) in patients with obstructive sleep apnea syndrome.
Obstructive Sleep Apnea Syndrome (OSAS) induces low-grade systemic and vascular inflammation, including activation of the leukotriene pathway.

In apneic patients, the urinary excretion of LTE4, a systemic marker of CysLT pathway activation, is increased in relation to the severity of OSAS and it's an independent predictor of cardiovascular risk event occurring at 10 years.

Montelukast is a CysLT1 receptor antagonist. By blocking CysLT1 receptors, montelukast prevents vasoconstriction, proliferation and migration of smooth muscle cells, adhesion molecule expression, and leukocyte recruitment induced by CysLTs.Montelukast may improve endothelial function and reduce vascular remodeling in apneic patients.

A pharmacological blockade of CysLT pathway would be an interesting therapeutic strategy to limit the cardiovascular consequences of OSAS.
Study Started
Nov 29
Primary Completion
Mar 20
Study Completion
Mar 20
Last Update
Feb 17

Drug Montelukast 10mg

The capsules will be presented in box of 95 capsules packaged in unit blister

Drug Placebo

Mannitol 350mg The capsules will be presented in box of 95 capsules packaged in unit blister

Montelukast Experimental

Drug :Montelukast, capsule, 10mg, one per day in the evening, one hour before or 2 hours post meal, length of treatment 3 months

Placebo Placebo Comparator

Drug: Mannitol, capsule, 350mg, one per day in the evening, one hour before or 2 hours post meal, length of treatment 3 months


Inclusion Criteria:

With mild to moderate obstructive sleep apnea syndrome (apnea / hypopnea index> 15 and <30 events per hour)
Little symptomatic (Epworth sleepiness score <10)
Polysomnography within 3 months prior to inclusion
With a history of myocardial infarction or stroke
Affiliation to Social Security or beneficiary of such a scheme
Signed consent

Exclusion Criteria:

OSAS support by PPC
Chronic inflammatory disease
Asthma previously treated with Montelukast
Chronic infectious disease
Epworth sleepiness scale ≥10
Contraindication to Montelukast: Hypersensitivity to the active substance or to the excipients
Contraindications to trinitrin: hypersensitivity to nitrates, state of shock, severe hypotension, association with sildenafil, obstructive cardiomyopathy, inferior right sided myocardial infarction with right ventricular extension, acute, except in case of signs left ventricular failure, intracranial hypertension, breastfeeding
Treatment with phenobarbital, phenytoin, rifampicin: risk of montelukast metabolism increase and thus decrease of its effectiveness
Persons referred in Articles L1121-5 to L1121-8 of the CSP (pregnant woman, parturient, nursing mothers, person deprived of liberty by judicial or administrative decision, person subject to a measure of legal protection, can not be included in clinical trials)
Subject in exclusion period of another study
Subject can not be contacted in case of emergency
No Results Posted