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”

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.

Intervention(s) in this Clinical Trial

• Drug: Montelukast
  • 1 pill per day for 4 months

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Montelukast
• Placebo Comparator: Placebo

Primary 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
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 10 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Chicago Other

Overall Clinical Trial Officials and Contacts

Leila Gozal, MD Principal Investigator University of Chicago  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01027806

Study ID Number: 09-008A

ClinicalTrials.gov Identifier: NCT01027806

Health Authority: United States: Food and Drug Administration