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Nasal Budesonide in Children With Rhinitis and/or Mild Obstructive Sleep Apnea Syndrome

NCT00560586 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2017-07-11

No results posted yet for this study

Summary

-Intranasal budesonide therapy may lead to improved symptoms and sleep study findings in children with mild obstructive sleep apnea with and without allergic rhinitis that would not be treated with T\&A. The aim of the study is to conduct a randomized double blind cross-over trial comparing the effect of once a day intranasal budesonide therapy vs. placebo in children with mild sleep apnea that would not be candidates for T\&A.

Conditions

Interventions

DRUG

Budesonide

1 puff each nostril (32 micrograms) at bedtime

DRUG

placebo

1 puff each nostril at bedtime

Sponsors & Collaborators

  • University of Louisville

    lead OTHER

Principal Investigators

  • Leila Kheirandish, MD · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2006-05-31
Completion
2007-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00560586 on ClinicalTrials.gov