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
See study documents
Clinicaltrials.gov ID
NCT00370097
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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
    Primary completion date:
    Not applicable
    Observational study model:
    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
    • Inclusion Criteria:
    • Subjects who have experienced 2 or more wheezing episodes in the previous 6 months.
    Inclusion and exclusion criteria
    Inclusion 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
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Huntington Beach, California, United States, 92647
    Status
    Will Be Recruiting
    Contact us
    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
    Contact us
    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75230
    Status
    Will Be Recruiting
    Contact us
    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73112
    Status
    Will Be Recruiting
    Contact us
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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
    Study complete
    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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