Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of Chicago GlaxoSmithKline |
---|---|
Information provided by: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00603044 |
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 |
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 |
Ages Eligible for Study: | 2 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Fuad M Baroody, MD | 773-702-5889 | fbaroody@surgery.bsd.uchicago.edu |
United States, Illinois | |
University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Principal Investigator: Fuad M Baroody, MD |
Principal Investigator: | Fuad M Baroody, MD | University of Chicago |
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 |
Health Authority: | United States: Institutional Review Board |
Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Respiration Disorders Sleep Apnea, Obstructive |
Fluticasone Dyssomnias Sleep Disorders Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |
Anti-Inflammatory Agents Respiratory System Agents Disease Nervous System Diseases Physiological Effects of Drugs Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions |
Pathologic Processes Autonomic Agents Syndrome Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents Dermatologic Agents |