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

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Louisville
• Treatments: Budesonide

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.