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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00603044
First received: January 3, 2008
Last updated: April 29, 2015
Last verified: April 2015
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Number of CD25 Pos/FoxP3 Positive Cells [ Time Frame: following adenoidectomy (2 weeks) ] [ Designated as safety issue: No ]
    The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25

  • Number of CD4 Pos/FOXP3 Positive Cells [ Time Frame: following adenoidectomy (2 weeks) ] [ Designated as safety issue: No ]
    The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25

  • IL-10 Staining Intensity [ Time Frame: following adenoidectomy (2 weeks) ] [ Designated as safety issue: No ]
    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 [ Time Frame: following adenoidectomy (2 weeks) ] [ Designated as safety issue: No ]
    Amount of IL-10 secreted by adenoid cells after PHA stimulation

  • Amount of TGF Secreted by Adenoid Cells After PHA Stimulation [ Time Frame: following adenoidectomy (2 weeks) ] [ Designated as safety issue: No ]
    Amount of TGF secreted by adenoid cells after PHA stimulation


Secondary Outcome Measures:
  • Adjusted Volume of the Removed Adenoids [ Time Frame: following adenoidectomy (2 weeks) ] [ Designated as safety issue: No ]
    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.


Enrollment: 24
Study Start Date: January 2008
Study Completion Date: August 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Other Name: Veramyst
No Intervention: No treatment

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.

  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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00603044

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
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
ClinicalTrials.gov Identifier: NCT00603044     History of Changes
Other Study ID Numbers: 15868B, 15868B
Study First Received: January 3, 2008
Results First Received: April 13, 2015
Last Updated: April 29, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Syndrome
Disease
Dyssomnias
Nervous System Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic
Fluticasone
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 02, 2015