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

NCT ID: NCT00603044

Last Updated: 2015-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-08-31

Brief Summary

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.

Detailed Description

The objective was to determine the effect of intranasal corticosteroid therapy on T-regulatory cells and other inflammatory cytokines in adenoid tissues in children with obstructive sleep apnea syndrome.Children were randomized to either no treatment or treatment with fluticasone furoate nasal spray, 55 μg/nostril daily, for 2 weeks before adenotonsillectomy. Adenoid tissue was obtained at the time of the procedure.

Conditions

Childhood Obstructive Sleep Apnea Syndrome (OSAS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Fluticasone furoate

55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy

Group Type: ACTIVE_COMPARATOR

fluticasone furoate

Intervention Type: DRUG

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

No treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

fluticasone furoate

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

Intervention Type: DRUG

Other Intervention Names

Veramyst

Eligibility 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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fuad M Baroody, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

15868B

Identifier Type: -

Identifier Source: secondary_id

15868B

Identifier Type: -

Identifier Source: org_study_id