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.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
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.
GSK Investigational Site
Huntington Beach, California, United States
GSK Investigational Site
Centennial, Colorado, United States
GSK Investigational Site
Jacksonville, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
Serum cortisol weighted mean(0-12h)
Time frame: throughout the study
Serum cortisol Cmin FP Cmaxss, AUClast and tmaxss Adverse events
Time frame: throughout the study
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GSK Investigational Site
Normal, Illinois, United States
GSK Investigational Site
Oklahoma City, Oklahoma, United States
GSK Investigational Site
Dallas, Texas, United States