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

NCT00599534 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-04-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Montelukast

4 mg oral tablets

DRUG

Placebo

5mg tablets

Sponsors & Collaborators

Principal Investigators

  • Leila Kheirandish, M.D. · University of Louisville

  • Lelia Kheirandish · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00599534 on ClinicalTrials.gov