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

Primary Purpose

Sleep Apnea

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Montelukast
Placebo
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea

Eligibility Criteria

2 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Louisville Pediatric Sleep Medicine Center
  • University of Louisville Pediatrics Sleep Medicine Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

4 mg tablet for 16 weeks

5 mg for 16 weeks

Outcomes

Primary Outcome Measures

The percentage of children converting from needing T&A surgery before treatment with montelukast to not needing surgery after treatment will be examined.

Secondary Outcome Measures

Full Information

First Posted
January 11, 2008
Last Updated
April 6, 2017
Sponsor
University of Louisville
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00599534
Brief Title
Controlled Trial on Effect of Montelukast Treatment in Children With Obstructive Sleep Apnea Syndrome
Official Title
A Randomized Double Blind Controlled Trial on the Effect of Treatment in Children With Obstructive Sleep Apnea Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Principal Investigator has transferred to another Institution
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Louisville
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
4 mg tablet for 16 weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
5 mg for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Montelukast
Intervention Description
4 mg oral tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
5mg tablets
Primary Outcome Measure Information:
Title
The percentage of children converting from needing T&A surgery before treatment with montelukast to not needing surgery after treatment will be examined.
Time Frame
Duration of Study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leila Kheirandish, M.D.
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lelia Kheirandish
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville Pediatric Sleep Medicine Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville Pediatrics Sleep Medicine Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27439031
Citation
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.
Results Reference
derived

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

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