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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionSleep Apnea
InterventionDrug: Montelukast
Drug: Placebo
PhasePhase 2
SponsorUniversity of Louisville
Responsible PartyUniversity of Louisville
ClinicalTrials.gov IdentifierNCT00599534
First ReceivedJanuary 11, 2008
Last UpdatedAugust 6, 2009
Last verifiedAugust 2009

Tracking Information[ + expand ][ + ]

First Received DateJanuary 11, 2008
Last Updated DateAugust 6, 2009
Start DateDecember 2007
Estimated Primary Completion DateDecember 2009
Current Primary Outcome MeasuresThe percentage of children converting from needing T&A surgery before treatment with montelukast to not needing surgery after treatment will be examined. [Time Frame: Duration of Study] [Designated as safety issue: Yes]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleControlled Trial on Effect of Montelukast Treatment in Children With Obstructive Sleep Apnea Syndrome
Official TitleA Randomized Double Blind Controlled Trial on the Effect of Treatment in Children With Obstructive Sleep Apnea Syndrome.
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 TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionSleep Apnea
InterventionDrug: Montelukast
4 mg oral tablets
Drug: Placebo
5mg tablets
Study Arm (s)
  • Active Comparator: 1
    4 mg tablet for 16 weeks
  • Placebo Comparator: 2
    5 mg for 16 weeks

Recruitment Information[ + expand ][ + ]

Recruitment StatusTerminated
Estimated Enrollment80
Estimated Completion DateDecember 2009
Estimated Primary Completion DateDecember 2009
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.
GenderBoth
Ages2 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00599534
Other Study ID NumbersIRB# 07.0135
Has Data Monitoring CommitteeNo
Information Provided ByUniversity of Louisville
Study SponsorUniversity of Louisville
CollaboratorsMerck Sharp & Dohme Corp.
Investigators Principal Investigator: Leila Kheirandish, M.D. University of LouisvillePrincipal Investigator: Lelia Kheirandish University of Louisville
Verification DateAugust 2009

Locations[ + expand ][ + ]

University of Louisville Pediatrics Sleep Medicine Center
Louisville, Kentucky, United States, 40202
University of Louisville Pediatric Sleep Medicine Center
Louisville, Kentucky, United States, 40202