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. |
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Condition | Sleep Apnea |
Intervention | Drug: Montelukast Drug: Placebo |
Phase | Phase 2 |
Sponsor | University of Louisville |
Responsible Party | University of Louisville |
ClinicalTrials.gov Identifier | NCT00599534 |
First Received | January 11, 2008 |
Last Updated | August 6, 2009 |
Last verified | August 2009 |
Tracking Information[ + expand ][ + ]
First Received Date | January 11, 2008 |
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Last Updated Date | August 6, 2009 |
Start Date | December 2007 |
Estimated Primary Completion Date | December 2009 |
Current Primary Outcome Measures | The 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 Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Controlled Trial on Effect of Montelukast Treatment in Children With Obstructive Sleep Apnea Syndrome |
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Official Title | A 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 Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Sleep Apnea |
Intervention | Drug: Montelukast 4 mg oral tablets Drug: Placebo 5mg tablets |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Terminated |
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Estimated Enrollment | 80 |
Estimated Completion Date | December 2009 |
Estimated Primary Completion Date | December 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. |
Gender | Both |
Ages | 2 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00599534 |
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Other Study ID Numbers | IRB# 07.0135 |
Has Data Monitoring Committee | No |
Information Provided By | University of Louisville |
Study Sponsor | University of Louisville |
Collaborators | Merck Sharp & Dohme Corp. |
Investigators | Principal Investigator: Leila Kheirandish, M.D. University of LouisvillePrincipal Investigator: Lelia Kheirandish University of Louisville |
Verification Date | August 2009 |
Locations[ + expand ][ + ]
University of Louisville Pediatrics Sleep Medicine Center | Louisville, Kentucky, United States, 40202 |
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University of Louisville Pediatric Sleep Medicine Center | Louisville, Kentucky, United States, 40202 |