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

Completed · Phase 4 · Has a placebo group

Conditions studied: Obstructive Sleep Apnea

In brief

-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.

Key facts

Study ID

NCT00560586

Run by

University of Louisville

People needed

62

Starts

2004-04-01

Expected to finish

2007-08-01

Last updated by the study team

2017-07-11

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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