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

NCT01027806 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2019-05-03

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Montelukast

1 pill per day for 4 months

Sponsors & Collaborators

Principal Investigators

  • Leila Gozal, MD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01027806 on ClinicalTrials.gov