Childhood Obstructive Sleep Apnea Syndrome (OSAS)Phase 4NCT00603044
Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome
A Phase 4 study testing fluticasone furoate in people with Childhood Obstructive Sleep Apnea Syndrome (OSAS), run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Childhood Obstructive Sleep Apnea Syndrome (OSAS)
- What is being tested?
- fluticasone furoate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Aug 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- fluticasone furoate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluticasone furoateDrug
Also called Veramyst
treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone furoate | Active comparator | 55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy Receives: Drug: fluticasone furoate |
| No treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of CD25 Pos/FoxP3 Positive Cells
The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25
Measured: following adenoidectomy (2 weeks)
Number of CD4 Pos/FOXP3 Positive Cells
The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25
Measured: following adenoidectomy (2 weeks)
IL-10 Staining Intensity
IL-10 staining intensity on immunohistochemical staining of adenoid tissues. Units are Integrated optical density (IOD)/100 micrometer squared.
Measured: following adenoidectomy (2 weeks)
Amount of IL-10 Secreted by Adenoid Cells After PHA Stimulation
Amount of IL-10 secreted by adenoid cells after PHA stimulation
Measured: following adenoidectomy (2 weeks)
Amount of TGF Secreted by Adenoid Cells After PHA Stimulation
Amount of TGF secreted by adenoid cells after PHA stimulation
Measured: following adenoidectomy (2 weeks)
Secondary outcomes (1)
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.
Measured: following adenoidectomy (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Childhood Obstructive Sleep Apnea Syndrome (OSAS)Studies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Fuad M Baroody, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603044
- Sponsor's protocol ID
- 15868B
- Other IDs
- 15868B
- Status last verified
- Apr 2015
- First submitted
- 3 Jan 2008
- Last updated
- 4 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT00603044
- Acronym / sponsor ID
- 15868B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Posted 4 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluticasone furoate | Active comparator | Drug: fluticasone furoate55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy |
| No treatment | No intervention | – |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluticasone furoateAlso: Veramysttreatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy | Drug | Fluticasone furoate |
Primary outcome
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
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
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.
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
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
1 secondary outcome
Adjusted Volume of the Removed Adenoids
Time frame: following adenoidectomy (2 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fuad M Baroody, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fluticasone furoate in people with Childhood Obstructive Sleep Apnea Syndrome (OSAS), run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of CD25 Pos/FoxP3 Positive Cells (time frame: following adenoidectomy (2 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2015.