Effect of Montelukast Therapy in Obstructive Sleep Apnea(OSA) Children

Phase 4

Terminated

• Conditions: Obstructive Sleep Apnea
• Interventions: Drug: Montelukast

• Registration Number: NCT01027806
• Lead Sponsor: University of Chicago

Brief Summary

The investigators leading hypotheses are:

* Oral therapy with montelukast may lead to improved sleep study findings in children with mild to moderate Obstructive Sleep Apnea Syndrome (OSAS) who require surgical removal of adenoids and tonsils for OSAS.

* A significant proportion of the children with OSAS treated with montelukast will show reduced severity of OSAS, and this will remove the need for surgical intervention.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-07
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Study Start: 2010-07
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2019-04
• Results First Submitted: 2019-04-11
• Results First Submitted QC: 2019-04-11
• Last Update Submitted: 2019-04-11
• Results First Posted: 2019-05-03
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Eligible for inclusion in the study will be 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

• Exclusion criteria will include: 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, and 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
Placebo	Montelukast	-
Montelukast	Montelukast	-

Primary Outcome Measures

Name	Time	Method
The Percentage of Children Experiencing a Reduction in Apnea-Hypopnea Index (API) From Baseline (Before Treatment) to After Treatment.	16 weeks

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States