Effect of Montelukast Therapy in Obstructive Sleep Apnea(OSA) Children (32543)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Chicago
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01027806
First received: December 7, 2009
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

The investigators leading hypotheses are:

  • Oral therapy with montelukast may lead to improved sleep study findings in children with mild to moderate Obstructive Sleep Apnea Syndrome (OSAS) who require surgical removal of adenoids and tonsils for OSAS.
  • A significant proportion of the children with OSAS treated with montelukast will show reduced severity of OSAS, and this will remove the need for surgical intervention.

Condition Intervention Phase
Obstructive Sleep Apnea
Drug: Montelukast
Phase 4

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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • The percentage of children converting from needing their tonsils and adenoids removed before treatment with montelukast to not needing surgery after treatment. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 83
Study Start Date: July 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Montelukast Drug: Montelukast
1 pill per day for 4 months
Placebo Comparator: Placebo Drug: Montelukast
1 pill per day for 4 months

  Eligibility

Ages Eligible for Study:   2 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible for inclusion in the study will be 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:

  • Exclusion criteria will include: 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, and 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: NCT01027806

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Leila K Gozal, MD    773-834-3815    lgozal@peds.bsd.uchicago.edu   
Contact: Richa S Kulkarni, BS, CRM    773-834-4018    rkulkarni@peds.bsd.uchicago.edu   
Principal Investigator: Leila K Gozal, MD         
Sponsors and Collaborators
University of Chicago
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Leila Gozal, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01027806     History of Changes
Other Study ID Numbers: 09-008A
Study First Received: December 7, 2009
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Chicago:
Children
Sleep
Obstructive Sleep Apnea

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 October 20, 2014