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

Obstructive Sleep Apnea Clinical Trial

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Official title:

A Randomized Double Blind Controlled Trial on the Effect of Montelukast Treatment in Children With Obstructive Sleep Apnea Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01027806
• Other study ID #: 09-008A
• Status: Terminated
• Phase: Phase 4
• Start date: July 2010
• Est. completion date: August 2014

Study information

• Verified date: April 2019
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Montelukast
1 pill per day for 4 months

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Children Experiencing a Reduction in Apnea-Hypopnea Index (API) From Baseline (Before Treatment) to After Treatment.		16 weeks