Clinical trial NCT00599534: Controlled Trial on Effect of Montelukast Treatment in Children With Obstructive Sleep Apnea Syndrome
Official title: A Randomized Double Blind Controlled Trial on the Effect of Treatment in Children With Obstructive Sleep Apnea Syndrome.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Sleep Apnea
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-01-23
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The percentage of children converting from needing T&A surgery before treatment with montelukast to not needing surgery after treatment will be examined.
timeFrame: Duration of Study
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Pediatric Sleep Medicine Center
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Pediatrics Sleep Medicine Center
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Leila Kheirandish, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Louisville
name: Lelia Kheirandish
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kheirandish-Gozal L, Bandla HP, Gozal D. Montelukast for Children with Obstructive Sleep Apnea: Results of a Double-Blind, Randomized, Placebo-Controlled Trial. Ann Am Thorac Soc. 2016 Oct;13(10):1736-1741. doi: 10.1513/AnnalsATS.201606-432OC.