NCT03545997

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-11-29
• Primary completion: 2020-03-20
• Completion: 2020-03-20
• First posted: 2018-06-06
• Last updated: 2021-02-17

Locations

8 sites across 1 country: France