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lack of recruitment
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| Name | Class |
|---|---|
| Act For Chronic Diseases | OTHER |
| Direction Générale de l'Offre de Soins | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast 10mg | Drug | The capsules will be presented in box of 95 capsules packaged in unit blister |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in FMD of the brachial artery between the beginning and end of each treatment period (Montelukast and placebo), expressed as absolute value (FMD unit is %) and measured in a standardized manner. | before and after 3 months treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of urinary LTE4 at the beginning and end of each treatment period | before and after 3 months the two periods of treatment | |
| 24h ambulatory blood pressure (systolic and diastolic) measurement | before and after 3 months of the two periods of treatment, and 15 days after the last period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Bron | 69677 | France | |||
| Métropole Savoie Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22244598 | Background | Ingelsson E, Yin L, Back M. Nationwide cohort study of the leukotriene receptor antagonist montelukast and incident or recurrent cardiovascular disease. J Allergy Clin Immunol. 2012 Mar;129(3):702-707.e2. doi: 10.1016/j.jaci.2011.11.052. Epub 2012 Jan 12. | |
| 22869829 | Background | Goldbart AD, Greenberg-Dotan S, Tal A. Montelukast for children with obstructive sleep apnea: a double-blind, placebo-controlled study. Pediatrics. 2012 Sep;130(3):e575-80. doi: 10.1542/peds.2012-0310. Epub 2012 Aug 6. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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It's a prospective, randomized, comparative vs placebo, double blind, multicenter, national study.
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Montelukast will be crushed and coated in a capsule, Mannitol is into a capsule too.
| Placebo | Drug | Mannitol 350mg The capsules will be presented in box of 95 capsules packaged in unit blister |
|
| Polysomnography at inclusion and at the end of each treatment period | inclusion and at the end of the two periods of treatment |
| Plasma concentration of Montelukast measured by HPLC-MS at the end of the Montelukast treatment period | at the end of Montelukast treatment period |
| Collection of adverse events | from inclusion to 15 days after the last period of treatment |
| Comparison of Cardiovascular Events occurence (myocardial infarction, Stroke, Cardiovascular Death) between the two periods | from inclusion to 15 days after the last period of treatment |
| Concentrations of plasma CRPus at baseline and at the beginning and end of each treatment period | before and after 3 months the two periods of treatment |
| Chambéry |
| 73000 |
| France |
| University Hospital | Clermont-Ferrand | 63003 | France |
| University Hospital Grenoble | Grenoble | 38000 | France |
| University Hospital | Grenoble | 38043 | France |
| Annecy Genevois Hospital | Metz-Tessy | 74370 | France |
| University Hospital | Pierre-Bénite | 69495 | France |
| University Hospital | Saint-Etienne | 42055 | France |
| 23204025 | Background | Cereza G, Garcia Dolade N, Laporte JR. Nightmares induced by montelukast in children and adults. Eur Respir J. 2012 Dec;40(6):1574-5. doi: 10.1183/09031936.00092812. No abstract available. |
| 23375423 | Background | Marchand MS, Jonville-Bera AP, Autret-Leca E; Association francaise des centres regionaux de pharmacovigilance. [Psychiatric disorders associated with montelukast: data from the National Pharmacovigilance Database]. Arch Pediatr. 2013 Mar;20(3):269-73. doi: 10.1016/j.arcped.2012.12.006. Epub 2013 Feb 1. French. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |