Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Principal Investigator has transferred to another Institution)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University of Louisville
ClinicalTrials.gov Identifier:
NCT00599534
First received: January 11, 2008
Last updated: August 6, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Sleep Apnea
Drug: Montelukast
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double Blind Controlled Trial on the Effect of Treatment in Children With Obstructive Sleep Apnea Syndrome.

Resource links provided by NLM:


Further study details as provided by University of Louisville:

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. [ Time Frame: Duration of Study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: December 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
4 mg tablet for 16 weeks
Drug: Montelukast
4 mg oral tablets
Placebo Comparator: 2
5 mg for 16 weeks
Drug: Placebo
5mg tablets

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.

  Eligibility

Ages Eligible for Study:   2 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599534

Locations
United States, Kentucky
University of Louisville Pediatric Sleep Medicine Center
Louisville, Kentucky, United States, 40202
University of Louisville Pediatrics Sleep Medicine Center
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Leila Kheirandish, M.D. University of Louisville
Principal Investigator: Lelia Kheirandish University of Louisville
  More Information

No publications provided

Responsible Party: Dr. Leila Kheirandish, University of Louisville Sleep Medicine
ClinicalTrials.gov Identifier: NCT00599534     History of Changes
Other Study ID Numbers: IRB# 07.0135
Study First Received: January 11, 2008
Last Updated: August 6, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic
Montelukast
Anti-Asthmatic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014