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

NCT00599534 | Withdrawn Phase 2

• 1 other identifier: IRB# 07.0135
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

4 mg tablet for 16 weeks

Drug: Montelukast

2

PLACEBO COMPARATOR

5 mg for 16 weeks

Drug: Placebo

Interventions

Montelukast DRUG

4 mg oral tablets

1

Placebo DRUG

5mg tablets

2

Eligibility Criteria

• Age: 2 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

University of Louisville Pediatric Sleep Medicine Center

Louisville, Kentucky, 40202, United States

Location

University of Louisville Pediatrics Sleep Medicine Center

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

• Kheirandish-Gozal L, Bandla HP, Gozal D. Montelukast for Children with Obstructive Sleep Apnea: Results of a Double-Blind, Randomized, Placebo-Controlled Trial. Ann Am Thorac Soc. 2016 Oct;13(10):1736-1741. doi: 10.1513/AnnalsATS.201606-432OC.

  PMID: 27439031 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

montelukast

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Leila Kheirandish, M.D.

  University of Louisville

  PRINCIPAL INVESTIGATOR

• Lelia Kheirandish

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 23, 2008
• Study Start: December 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

US (2)