Montelukast for Patients With Obstructive Sleep Apnea Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-29

Study Completion Date

2020-03-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sleep Apnea, Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

It's a prospective, randomized, comparative vs placebo, double blind, multicenter, national study.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Montelukast will be crushed and coated in a capsule, Mannitol is into a capsule too.

Study Groups

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Montelukast

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

Group Type EXPERIMENTAL

Montelukast 10mg

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Montelukast 10mg

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Interventions

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Montelukast 10mg

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
* Cancer
* 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

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No