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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2007 by University of Louisville.
Recruitment status was:  Active, not recruiting
Information provided by:
University of Louisville Identifier:
First received: November 15, 2007
Last updated: November 16, 2007
Last verified: July 2007
-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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nasal Budesonide in Children With Rhinitis and/or Mild Obstructive Sleep Apnea Syndrome

Resource links provided by NLM:

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

  Show Detailed Description


Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00560586

United States, Kentucky
Kosair Children's Hospital Sleep Center
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Principal Investigator: Leila Kheirandish, MD University of Louisville
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00560586     History of Changes
Other Study ID Numbers: 388.03
UofL Project ID 04-0280X02
Study First Received: November 15, 2007
Last Updated: November 16, 2007

Keywords provided by University of Louisville:
sleep fragmentation

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on June 23, 2017