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

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00599534
• Other study ID #: IRB# 07.0135
• Status: Withdrawn
• Phase: Phase 2
• First received: January 11, 2008
• Last updated: April 6, 2017
• Start date: December 2007
• Est. completion date: December 2009

Study information

• Verified date: April 2017
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Montelukast
4 mg oral tablets
• Placebo
5mg tablets

Locations

Country	Name	City	State
United States	University of Louisville Pediatric Sleep Medicine Center	Louisville	Kentucky
United States	University of Louisville Pediatrics Sleep Medicine Center	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	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 converting from needing T&A surgery before treatment with montelukast to not needing surgery after treatment will be examined.		Duration of Study