Skip to main content
OpenTrials
Completed

NCT Number: NCT00603044

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Childhood Obstructive Sleep Apnea Syndrome (OSAS)

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluticasone Furoate

Drug

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

Other names: Veramyst

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • GlaxoSmithKline

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 28, 2008
Registry last updated
May 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.