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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by University of Chicago.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00603044
First received: January 3, 2008
Last updated: July 16, 2008
Last verified: July 2008
History of Changes
  Purpose

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: Treatment
Official Title: Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Estimated Enrollment: 20
Study Start Date: January 2008
Estimated Study Completion Date: June 2009
Estimated 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

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603044

Contacts
Contact: Fuad M Baroody, MD 773-702-5889 fbaroody@surgery.bsd.uchicago.edu

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

No publications provided

Responsible Party: Fuad M. Baroody, MD, University of Chicago
ClinicalTrials.gov Identifier: NCT00603044     History of Changes
Other Study ID Numbers: 15868B, 15868B
Study First Received: January 3, 2008
Last Updated: July 16, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Fluticasone
 Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013