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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

January 3, 2008
July 16, 2008
January 2008
January 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00603044 on ClinicalTrials.gov Archive Site
weight of the removed adenoids to be compared between the 2 groups. [ Time Frame: post adenoidectomy ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome
Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Childhood Obstructive Sleep Apnea Syndrome (OSAS)
Drug: fluticasone furoate
treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy
Other Name: Veramyst
  • Active Comparator: 1
    treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy
    Intervention: Drug: fluticasone furoate
  • No Intervention: 2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
June 2009
January 2009   (final data collection date for primary outcome measure)

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.
Both
2 Years to 12 Years
No
Contact: Fuad M Baroody, MD 773-702-5889 fbaroody@surgery.bsd.uchicago.edu
United States
 
NCT00603044
15868B, 15868B
No
Fuad M. Baroody, MD, University of Chicago
University of Chicago
GlaxoSmithKline
Principal Investigator: Fuad M Baroody, MD University of Chicago
University of Chicago
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP