FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects
PD of Hydrofluoroalkane Propellant of Inhaled Fluticasone Propionate Following Administration in Pediatric Subjects 6-12 Months of Age With Asthma
1 other identifier
interventional
16
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 asthma
Started Aug 2006
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2006
CompletedFirst Posted
Study publicly available on registry
August 30, 2006
CompletedStudy Start
First participant enrolled
August 30, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2007
CompletedSeptember 11, 2017
September 1, 2017
8 months
August 28, 2006
September 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum cortisol weighted mean(0-12h)
throughout the study
Secondary Outcomes (1)
Serum cortisol Cmin FP Cmaxss, AUClast and tmaxss Adverse events
throughout the study
Study Arms (1)
Subjects receiving HFA
EXPERIMENTALSubjects 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
Interventions
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.
Subjects will receive FP-matched placebo using an Aerochamber Plus with Infant Mask.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (7)
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Centennial, Colorado, 80112, United States
GSK Investigational Site
Jacksonville, Florida, 32207, United States
GSK Investigational Site
Atlanta, Georgia, 30309-7520, United States
GSK Investigational Site
Normal, Illinois, 61761, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2006
First Posted
August 30, 2006
Study Start
August 30, 2006
Primary Completion
April 12, 2007
Study Completion
April 12, 2007
Last Updated
September 11, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.