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

This study is currently recruiting participants.

Verified by University of Chicago, July 2008

First Received: January 3, 2008 Last Updated: July 16, 2008 History of Changes

Sponsor:	University of Chicago
Collaborator:	GlaxoSmithKline
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00603044

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea Tonsils and Adenoids

Drug Information available for: Fluticasone propionate Fluticasone

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
1: Active Comparator 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
2: No Intervention

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

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Sleep Apnea, Obstructive
Physiological Effects of Drugs
Sleep Disorders
Sleep Disorders, Intrinsic
Signs and Symptoms
Pathologic Processes
Respiratory Tract Diseases
Syndrome
Therapeutic Uses
Signs and Symptoms, Respiratory
Fluticasone

Dermatologic Agents
Sleep Apnea Syndromes
Disease
Apnea
Nervous System Diseases
Respiration Disorders
Dyssomnias
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on February 08, 2010