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

Official Title: “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.

Intervention(s) in this Clinical Trial

• Drug: fluticasone furoate
  • treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy
• No Intervention: 2

Primary Measures

• the number of cells positive for IL-10 and FOXP3 on immunohistochemical staining of adenoid tissues
  • Time Frame: following adeniodectomy
    Safety Issue?: No
• the amount of IL-10 and TGF-alpha secreted by adenoid cells after stimulation
  • Time Frame: post adenoidectomy
    Safety Issue?: No

Secondary Measures

• weight of the removed adenoids to be compared between the 2 groups.
  • Time Frame: post adenoidectomy
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 12 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Chicago Other

Overall Clinical Trial Officials and Contacts

Fuad M Baroody, MD Principal Investigator University of Chicago  

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

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00603044

Study ID Number: 15868B

ClinicalTrials.gov Identifier: NCT00603044

Health Authority: United States: Institutional Review Board