Effect of Montelukast Therapy in Obstructive Sleep Apnea(OSA) Children (32543)
This study is currently recruiting participants.
Verified September 2011 by University of Chicago
Sponsor:
University of Chicago
Collaborator:
Merck
Information provided by (Responsible Party):
Leila Gozal, University of Chicago
ClinicalTrials.gov Identifier:
NCT01027806
First received: December 7, 2009
Last updated: September 17, 2011
Last verified: September 2011
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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: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (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
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
Investigators
| Principal Investigator: | Leila Gozal, MD | University of Chicago |
More Information
No publications provided
| Responsible Party: | Leila Gozal, Associate Professor, Director of Clinical Research, Section of Pediatric Sleep Medicine, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT01027806 History of Changes |
| Other Study ID Numbers: | 09-008A |
| Study First Received: | December 7, 2009 |
| Last Updated: | September 17, 2011 |
| 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 Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders |
Nervous System Diseases Montelukast Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013