FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: FLOVENT (fluticasone propionate) HFA (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: See Detailed Description
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Serum cortisol weighted mean(0-12h)
Secondary outcome: Serum cortisol Cmin FP Cmaxss, AUClast and tmaxss Adverse events
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
Eligibility
Minimum age: 6 Months.
Maximum age: 12 Months.
Gender(s): Both.
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
Locations and Contacts
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
Additional Information
Starting date: August 2006
Last updated: May 15, 2009
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