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

University of Louisville (UOFL)

Status and phase

Withdrawn

Phase 2

Conditions

Sleep Apnea

Treatments

Drug: Placebo

Drug: Montelukast

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00599534

IRB# 07.0135

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

2 to 9 years old

Volunteers

No Healthy Volunteers

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.