Effect of Montelukast Therapy in Obstructive Sleep Apnea(OSA) Children | RxWiki

Effect of Montelukast Therapy in Obstructive Sleep Apnea(OSA) Children

Overview[ - collapse ][ - ]

Purpose	The investigators leading hypotheses are: - Oral therapy with montelukast may lead to improved sleep study findings in children with mild to moderate Obstructive Sleep Apnea Syndrome (OSAS) who require surgical removal of adenoids and tonsils for OSAS. - A significant proportion of the children with OSAS treated with montelukast will show reduced severity of OSAS, and this will remove the need for surgical intervention.
Condition	Obstructive Sleep Apnea
Intervention	Drug: Montelukast
Phase	Phase 4
Sponsor	University of Chicago
Responsible Party	University of Chicago
ClinicalTrials.gov Identifier	NCT01027806
First Received	December 7, 2009
Last Updated	September 17, 2011
Last verified	September 2011

Tracking Information[ + expand ][ + ]

First Received Date	December 7, 2009
Last Updated Date	September 17, 2011
Start Date	July 2010
Estimated Primary Completion Date	March 2013
Current Primary Outcome Measures	The percentage of children converting from needing their tonsils and adenoids removed before treatment with montelukast to not needing surgery after treatment. [Time Frame: 4 months] [Designated as safety issue: No]
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Effect of Montelukast Therapy in Obstructive Sleep Apnea(OSA) Children
Official Title	A Randomized Double Blind Controlled Trial on the Effect of Montelukast Treatment in Children With Obstructive Sleep Apnea Syndrome
Brief Summary	The investigators leading hypotheses are: - Oral therapy with montelukast may lead to improved sleep study findings in children with mild to moderate Obstructive Sleep Apnea Syndrome (OSAS) who require surgical removal of adenoids and tonsils for OSAS. - A significant proportion of the children with OSAS treated with montelukast will show reduced severity of OSAS, and this will remove the need for surgical intervention.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Condition	Obstructive Sleep Apnea
Intervention	Drug: Montelukast 1 pill per day for 4 months
Study Arm (s)	Active Comparator: Montelukast Placebo Comparator: Placebo

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	83
Estimated Completion Date	March 2013
Estimated Primary Completion Date	March 2013
Eligibility Criteria	Inclusion Criteria: - Eligible for inclusion in the study will be 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: - Exclusion criteria will include: 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, and 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	NCT01027806
Other Study ID Numbers	09-008A
Has Data Monitoring Committee	No
Information Provided By	University of Chicago
Study Sponsor	University of Chicago
Collaborators	Merck Sharp & Dohme Corp.
Investigators	Principal Investigator: Leila Gozal, MD University of Chicago
Verification Date	September 2011

Locations[ + expand ][ + ]