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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Sleep Apnea

In brief

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.

Key facts

Study ID

NCT00599534

Run by

University of Louisville

People needed

0

Starts

2007-12-01

Expected to finish

2009-12-01

Last updated by the study team

2017-04-10

Who can join

Age: 2 and older, up to 9. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Louisville Pediatric Sleep Medicine Center — Louisville, Kentucky, United States
• University of Louisville Pediatrics Sleep Medicine Center — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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