Back to resultsFLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects
Primary Purpose
Asthma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FLOVENT (fluticasone propionate) HFA
Placebo HFA
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma infants FLOVENT spacer
Eligibility Criteria
Inclusion Criteria: Subjects who have experienced 2 or more wheezing episodes in the previous 6 months. Subjects may not have taken any corticosteroids in the 4 weeks prior to dosing Parents/guardians should be able to read and comprehend diary information collected throughout the study Parents must be able to demonstrate the ability to use the facemask and spacer used to administer study drug Exclusion criteria: Subjects who weigh less than 7 kg Subjects who are taking any drugs that inhibit or induce the cytochrome P450 isoform Any parents who have a history of psychiatric disease, intellectual deficiency, substance abuse that would compromise the validity of the consent
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects receiving HFA
Arm Description
Subjects in Session 1 will receive two inhalations of placebo HFA by meter-dose inhaler (MDI) twice daily and in Session 2 subjects will receive two inhalations of fluticasone propionate (FP) HFA MDI 44 mcg twice daily
Outcomes
Primary Outcome Measures
Serum cortisol weighted mean(0-12h)
Secondary Outcome Measures
Serum cortisol Cmin FP Cmaxss, AUClast and tmaxss Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00370097
Brief Title
FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects
Official Title
PD of Hydrofluoroalkane Propellant of Inhaled Fluticasone Propionate Following Administration in Pediatric Subjects 6-12 Months of Age With Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 30, 2006 (Actual)
Primary Completion Date
April 12, 2007 (Actual)
Study Completion Date
April 12, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to address an Food Drug and Administration (FDA) request to provide safety data in pre-asthmatic patients, ages 6 months to <12 months, following administration of fluticasone propionate HFA.
Detailed Description
A repeat-dose, open-label, 2-session study to assess the systemic exposure to, and pharmacodynamics of, fluticasone propionate HFA inhalation aerosol 88mcg administered twice-daily for 28 days delivered via an MDI and valved holding chamber with infant facemask to subjects ages 6 months to <12 months who have experienced 2 or more wheezing episodes in the preceding 6 months
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma infants FLOVENT spacer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects receiving HFA
Arm Type
Experimental
Arm Description
Subjects in Session 1 will receive two inhalations of placebo HFA by meter-dose inhaler (MDI) twice daily and in Session 2 subjects will receive two inhalations of fluticasone propionate (FP) HFA MDI 44 mcg twice daily
Intervention Type
Drug
Intervention Name(s)
FLOVENT (fluticasone propionate) HFA
Intervention Description
FLOVENT HFA consists of a white to off-white suspension of FP (micronized) in a liquefied hydrofluoroalkane propellant, 1,1,1,2-tetrafluoroethane. Subject will receive FP HFA using an Aerochamber Plus with Infant Mask.
Intervention Type
Drug
Intervention Name(s)
Placebo HFA
Intervention Description
Subjects will receive FP-matched placebo using an Aerochamber Plus with Infant Mask.
Primary Outcome Measure Information:
Title
Serum cortisol weighted mean(0-12h)
Time Frame
throughout the study
Secondary Outcome Measure Information:
Title
Serum cortisol Cmin FP Cmaxss, AUClast and tmaxss Adverse events
Time Frame
throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who have experienced 2 or more wheezing episodes in the previous 6 months.
Subjects may not have taken any corticosteroids in the 4 weeks prior to dosing
Parents/guardians should be able to read and comprehend diary information collected throughout the study
Parents must be able to demonstrate the ability to use the facemask and spacer used to administer study drug
Exclusion criteria:
Subjects who weigh less than 7 kg
Subjects who are taking any drugs that inhibit or induce the cytochrome P450 isoform
Any parents who have a history of psychiatric disease, intellectual deficiency, substance abuse that would compromise the validity of the consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
GSK Investigational Site
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
GSK Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309-7520
Country
United States
Facility Name
GSK Investigational Site
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
GSK Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FAS106533
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FAS106533
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FAS106533
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FAS106533
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FAS106533
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FAS106533
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FAS106533
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects
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