Nasal Budesonide in Children With Rhinitis and/or Mild Obstructive Sleep Apnea Syndrome - Full Text View

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

MedlinePlus related topics:

Sleep Apnea

ChemIDplus related topics:

Budesonide Salicylsalicylic acid Sodium salicylate

U.S. FDA Resources

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

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

Publications indexed to this study:

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
First Received:	November 15, 2007
Last Updated:	November 16, 2007
ClinicalTrials.gov Identifier:	NCT00560586
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Louisville:

sleep fragmentation

apnea

hypoxia

Study placed in the following topic categories:

Sleep Apnea Syndromes

Otorhinolaryngologic Diseases

Apnea

Salicylsalicylic acid

Sleep Apnea, Obstructive

Respiration Disorders

Budesonide

Sodium Salicylate

Sleep Disorders

Dyssomnias

Rhinitis

Sleep Disorders, Intrinsic

Signs and Symptoms

Respiratory Tract Diseases

Respiratory Tract Infections

Signs and Symptoms, Respiratory

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on September 22, 2008

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