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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00599534
Recruitment Status : Withdrawn (Principal Investigator has transferred to another Institution)
First Posted : January 23, 2008
Last Update Posted : April 10, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Drug: Montelukast Drug: Placebo Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double Blind Controlled Trial on the Effect of Treatment in Children With Obstructive Sleep Apnea Syndrome.
Study Start Date : December 2007
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Montelukast
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00599534

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.
Principal Investigator: Leila Kheirandish, M.D. University of Louisville
Principal Investigator: Lelia Kheirandish University of Louisville
More Information

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT00599534     History of Changes
Other Study ID Numbers: IRB# 07.0135
First Posted: January 23, 2008    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action