Controlled Trial on Effect of Montelukast Treatment in Children With Obstructive Sleep Apnea Syndrome

Phase 2

Withdrawn

• Conditions: Sleep Apnea
• Interventions: Drug: Placebo; Drug: Montelukast

• Registration Number: NCT00599534
• Lead Sponsor: University of Louisville

Brief Summary

Oral therapy with montelukast may lead to improved polysomnographic findings in children with mild to moderate OSAS with and without allergic rhinitis who a priori require T\&A for OSAS.

- A significant proportion of the children with OSAS treated with montelukast will show reduced severity of OSAS, and this will obviate the need for surgical T\&A.

Detailed Description

Primary Specific Aim. To conduct a randomized double blind 16-week trial comparing the effect on polysomnographic measures of the administration of once a day oral montelukast therapy vs. placebo in children with OSAS.

Secondary Specific Aim. For all children with the original AHI at diagnosis of \>2 hrTST, we expect improvements in the severity of sleep apnea to occur following treatment with montelukast. Therefore, we will examine the overall reduction in AHI and also how many of these children have AHI\< 2 after the 16-week treatment. In other words, the percentage of children converting from needing T\&A surgery before treatment with montelukast to not needing surgery after treatment will be examined.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-11
• Study First Submitted QC: 2008-01-22
• Study First Posted: 2008-01-23
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-06
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Symptomatic snoring children > 2 years of age and < 10 years of age, who snore and have an apnea hypopnea index (AHI) >2/hrTST (hour total sleep time), and in whom T&A is therefore contemplated. Also among these, we will include children referred for evaluation for snoring who have a history of allergic rhinitis.

Exclusion Criteria

• Hypersensitivity to montelukast
• Immunodeficiency or immunosuppressant therapy
• Craniofacial, neuromuscular, syndromic or defined genetic abnormalities
• Acute upper respiratory tract infection
• Systemic corticosteroid therapy or antibiotic therapy in the 2 weeks previous to the study
• Children who already had adenotonsillectomy.

In addition, children chronically receiving oral antihistamine preparations or nasal decongestants will be required to continue using these medications throughout the duration of the study. Patients receiving immunotherapy will continue on the same regimen without escalation of dose and frequency throughout the duration of the study. In addition, patients with severe OSA who in the opinion of their treating physicians require early surgical intervention for their OSA will be excluded from eligibility to the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	5 mg for 16 weeks
1	Montelukast	4 mg tablet for 16 weeks

Primary Outcome Measures

Name	Time	Method
The percentage of children converting from needing T&A surgery before treatment with montelukast to not needing surgery after treatment will be examined.	Duration of Study

Trial Locations

Locations (2)

University of Louisville Pediatric Sleep Medicine Center; 🇺🇸 Louisville, Kentucky, United States

University of Louisville Pediatrics Sleep Medicine Center; 🇺🇸 Louisville, Kentucky, United States