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

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ClinicalTrials.gov Identifier: NCT00603044
Recruitment Status : Completed
First Posted : January 28, 2008
Results First Posted : May 4, 2015
Last Update Posted : May 4, 2015
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Childhood Obstructive Sleep Apnea Syndrome (OSAS) Drug: fluticasone furoate Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome
Study Start Date : January 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number of CD25 Pos/FoxP3 Positive Cells [ Time Frame: following adenoidectomy (2 weeks) ]
    The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25

  2. Number of CD4 Pos/FOXP3 Positive Cells [ Time Frame: following adenoidectomy (2 weeks) ]
    The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25

  3. IL-10 Staining Intensity [ Time Frame: following adenoidectomy (2 weeks) ]
    IL-10 staining intensity on immunohistochemical staining of adenoid tissues. Units are Integrated optical density (IOD)/100 micrometer squared.

  4. Amount of IL-10 Secreted by Adenoid Cells After PHA Stimulation [ Time Frame: following adenoidectomy (2 weeks) ]
    Amount of IL-10 secreted by adenoid cells after PHA stimulation

  5. Amount of TGF Secreted by Adenoid Cells After PHA Stimulation [ Time Frame: following adenoidectomy (2 weeks) ]
    Amount of TGF secreted by adenoid cells after PHA stimulation


Secondary Outcome Measures :
  1. Adjusted Volume of the Removed Adenoids [ Time Frame: following adenoidectomy (2 weeks) ]
    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.



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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00603044     History of Changes
Other Study ID Numbers: 15868B
15868B
First Posted: January 28, 2008    Key Record Dates
Results First Posted: May 4, 2015
Last Update Posted: May 4, 2015
Last Verified: April 2015

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