Last updated: 11/04/2018 06:40:53

FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects

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GSK study ID
FAS106533
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Clinicaltrials.gov ID
NCT00370097
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: PD of Hydrofluoroalkane propellant of inhaled fluticasone propionate following administration in pediatric subjects 6-12 months of age with asthma
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Serum cortisol weighted mean(0-12h)

Timeframe: throughout the study

Secondary outcomes:

Serum cortisol Cmin FP Cmaxss, AUClast and tmaxss Adverse events

Timeframe: throughout the study

Interventions:
Drug: FLOVENT (fluticasone propionate) HFA
Drug: Placebo HFA
Enrollment:
16
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
August 2006 to April 2007
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
6 - 12 months
Accepts healthy volunteers
No
  • 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
  • Subjects who weigh less than 7 kg
  • Subjects who are taking any drugs that inhibit or induce the cytochrome P450 isoform
Inclusion and exclusion 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

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Will Be Recruiting
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Location
GSK Investigational Site
Jacksonville, Florida, United States, 32207
Status
Will Be Recruiting
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Location
GSK Investigational Site
Atlanta, Georgia, United States, 30309-7520
Status
Will Be Recruiting
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Location
GSK Investigational Site
Normal, Illinois, United States, 61761
Status
Will Be Recruiting
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Location
GSK Investigational Site
Dallas, Texas, United States, 75230
Status
Will Be Recruiting
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Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Will Be Recruiting
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Location
GSK Investigational Site
Centennial, Colorado, United States, 80112
Status
Will Be Recruiting
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-12-04

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
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Results for study FAS106533 can be found on the GSK Clinical Study Register.
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