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

Primary Purpose

Childhood Obstructive Sleep Apnea Syndrome (OSAS)

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
fluticasone furoate
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Childhood Obstructive Sleep Apnea Syndrome (OSAS)

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Fluticasone furoate

No treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Number of CD25 Pos/FoxP3 Positive Cells
The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25
Number of CD4 Pos/FOXP3 Positive Cells
The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25
IL-10 Staining Intensity
IL-10 staining intensity on immunohistochemical staining of adenoid tissues. Units are Integrated optical density (IOD)/100 micrometer squared.
Amount of IL-10 Secreted by Adenoid Cells After PHA Stimulation
Amount of IL-10 secreted by adenoid cells after PHA stimulation
Amount of TGF Secreted by Adenoid Cells After PHA Stimulation
Amount of TGF secreted by adenoid cells after PHA stimulation

Secondary Outcome Measures

Adjusted Volume of the Removed Adenoids
To adjust for different weights of the children, the volume of the adenoids, estimated by water displacement in the operating room in mL, was divided by the respective weights (kg) of the patients and multiplied by 100.

Full Information

First Posted
January 3, 2008
Last Updated
April 29, 2015
Sponsor
University of Chicago
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00603044
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obstructive Sleep Apnea Syndrome (OSAS)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluticasone furoate
Arm Type
Active Comparator
Arm Description
55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy
Arm Title
No treatment
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
fluticasone furoate
Other Intervention Name(s)
Veramyst
Intervention Description
treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy
Primary Outcome Measure Information:
Title
Number of CD25 Pos/FoxP3 Positive Cells
Description
The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25
Time Frame
following adenoidectomy (2 weeks)
Title
Number of CD4 Pos/FOXP3 Positive Cells
Description
The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25
Time Frame
following adenoidectomy (2 weeks)
Title
IL-10 Staining Intensity
Description
IL-10 staining intensity on immunohistochemical staining of adenoid tissues. Units are Integrated optical density (IOD)/100 micrometer squared.
Time Frame
following adenoidectomy (2 weeks)
Title
Amount of IL-10 Secreted by Adenoid Cells After PHA Stimulation
Description
Amount of IL-10 secreted by adenoid cells after PHA stimulation
Time Frame
following adenoidectomy (2 weeks)
Title
Amount of TGF Secreted by Adenoid Cells After PHA Stimulation
Description
Amount of TGF secreted by adenoid cells after PHA stimulation
Time Frame
following adenoidectomy (2 weeks)
Secondary Outcome Measure Information:
Title
Adjusted Volume of the Removed Adenoids
Description
To adjust for different weights of the children, the volume of the adenoids, estimated by water displacement in the operating room in mL, was divided by the respective weights (kg) of the patients and multiplied by 100.
Time Frame
following adenoidectomy (2 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fuad M Baroody, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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