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Sponsored by: |
University of Louisville |
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Information provided by: | University of Louisville |
ClinicalTrials.gov Identifier: | NCT00560586 |
-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.
Condition | Intervention | Phase |
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Obstructive Sleep Apnea |
Drug: Budesonide |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment |
Official Title: | Nasal Budesonide in Children With Rhinitis and/or Mild Obstructive Sleep Apnea Syndrome |
Enrollment: | 62 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | August 2008 |
Arms | Assigned Interventions |
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P,B: Experimental
Placebo or Budesonide for 6 weeks followed by crossover to the other treatment
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Drug: Budesonide
1 ouff each nostril (32 micrograms) at bedtime
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Ages Eligible for Study: | 6 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Kentucky | |
Kosair Children's Hospital Sleep Center | |
Louisville, Kentucky, United States, 40202 |
Principal Investigator: | Leila Kheirandish, MD | University of Louisville |
Study ID Numbers: | 388.03, UofL Project ID 04-0280X02 |
Study First Received: | November 15, 2007 |
Last Updated: | November 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00560586 |
Health Authority: | United States: Institutional Review Board |
sleep fragmentation apnea hypoxia |
Sleep Apnea Syndromes Otorhinolaryngologic Diseases Apnea Sleep Apnea, Obstructive Respiration Disorders Budesonide Sleep Disorders |
Dyssomnias Rhinitis Sleep Disorders, Intrinsic Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms, Respiratory |
Anti-Inflammatory Agents Respiratory System Agents Nervous System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Glucocorticoids |
Hormones Nose Diseases Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |