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

This study is ongoing, but not recruiting participants.

First Received: November 15, 2007 Last Updated: November 16, 2007 History of Changes

Sponsor:	University of Louisville
Information provided by:	University of Louisville
ClinicalTrials.gov Identifier:	NCT00560586

Purpose

-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
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

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by University of Louisville:

Primary Outcome Measures:

overnight sleep study respiratory measures [ Time Frame: 6 weeks ]

Secondary Outcome Measures:

adenoid size by X ray [ Time Frame: 6 weeks ]

Enrollment:	62
Study Start Date:	August 2005
Estimated Study Completion Date:	August 2008

Arms	Assigned Interventions
P,B: Experimental Placebo or Budesonide for 6 weeks followed by crossover to the other treatment	Drug: Budesonide 1 ouff each nostril (32 micrograms) at bedtime

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Eligibility

Ages Eligible for Study:	6 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Children >6 years of age and < 12 years of age, who snore and have an apnea hypopnea index (AHI) < or equal 7 or Respiratory arousal index > or equal 2

Exclusion Criteria:

Hypersensitivity to budesonide
Recent nasal trauma
Nasal surgery or nasal septum perforation
Current therapy with drugs interacting with budesonide (erythromycin clarythromycin, ketoconazole and cimetidine)
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 the past 12 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560586

Locations

United States, Kentucky
Kosair Children's Hospital Sleep Center
Louisville, Kentucky, United States, 40202

Sponsors and Collaborators

University of Louisville

Investigators

Principal Investigator:

Leila Kheirandish, MD

University of Louisville

More Information

No publications provided by University of Louisville

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Kheirandish-Gozal L, Gozal D. Intranasal budesonide treatment for children with mild obstructive sleep apnea syndrome. Pediatrics. 2008 Jul;122(1):e149-55.

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 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Louisville:

sleep fragmentation
apnea
hypoxia

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Sleep Apnea, Obstructive
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Sleep Disorders
Rhinitis
Hormones
Sleep Disorders, Intrinsic
Signs and Symptoms
Pathologic Processes
Respiratory Tract Infections
Respiratory Tract Diseases
Therapeutic Uses
Syndrome

Signs and Symptoms, Respiratory
Sleep Apnea Syndromes
Otorhinolaryngologic Diseases
Disease
Apnea
Respiration Disorders
Nervous System Diseases
Budesonide
Dyssomnias
Anti-Asthmatic Agents
Glucocorticoids
Nose Diseases
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010