Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome

This study has been completed.
Information provided by (Responsible Party):
University of Chicago Identifier:
First received: January 3, 2008
Last updated: November 4, 2014
Last verified: November 2014

The purpose of this research is to find out how a nasal spray (fluticasone furoate), sometimes given to children with obstructive sleep apnea syndrome (OSAS), works on certain cells within a child's adenoids. We hypothesize that intranasal steroids lead to an upregulation of T regulatory cells in the adenoid tissues of children with OSAS. This will result in a local reduction in inflammation and edema explaining the improvement in OSAS.

Condition Intervention Phase
Childhood Obstructive Sleep Apnea Syndrome (OSAS)
Drug: fluticasone furoate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome

Resource links provided by NLM:

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • the number of cells positive for IL-10 and FOXP3 on immunohistochemical staining of adenoid tissues [ Time Frame: following adeniodectomy ] [ Designated as safety issue: No ]
  • the amount of IL-10 and TGF-alpha secreted by adenoid cells after stimulation [ Time Frame: post adenoidectomy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • weight of the removed adenoids to be compared between the 2 groups. [ Time Frame: post adenoidectomy ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2008
Study Completion Date: August 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy
Drug: fluticasone furoate
treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy
Other Name: Veramyst
No Intervention: 2


Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age: between 2 and 12 years
  • Polysomnogram results showing AHI >5/hr irrespective of saturations
  • No other significant medical problems except well controlled asthma
  • No chronic medication intake except bronchodilators and leukotriene receptor antagonists
  • No systemic steroids within the past month
  • No intranasal steroids within the past 2 weeks

Exclusion Criteria:

  • Patients with OSAS who are overweight (BMI>95th percentile for age) or who have neurological or craniofacial abnormalities as these tend to have OSAS related to these factors per se.
  • Females of the specified age group who have already had their first period.
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Please refer to this study by its identifier: NCT00603044

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Principal Investigator: Fuad M Baroody, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago Identifier: NCT00603044     History of Changes
Other Study ID Numbers: 15868B, 15868B
Study First Received: January 3, 2008
Last Updated: November 4, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Nervous System Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses processed this record on April 16, 2015