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A repeat-dose, open-label, 2-session study to assess the systemic exposure to, and pharmacodynamics of, fluticasone propionate HFA inhalation aerosol 88 mcg administered twice-daily for 28 days delivered via an MDI and valved holding chamber with infant face mask to subjects ages 6 months to <12 months who have experienced 2 or more wheezing episodes in the preceding 6 months.

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Trial Profile

A repeat-dose, open-label, 2-session study to assess the systemic exposure to, and pharmacodynamics of, fluticasone propionate HFA inhalation aerosol 88 mcg administered twice-daily for 28 days delivered via an MDI and valved holding chamber with infant face mask to subjects ages 6 months to <12 months who have experienced 2 or more wheezing episodes in the preceding 6 months.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 28 Jun 2023

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At a glance

  • Drugs Fluticasone propionate (Primary)
  • Indications Asthma; Wheezing
  • Focus Pharmacodynamics
  • Sponsors GlaxoSmithKline; GSK
  • Most Recent Events

    • 23 Nov 2016 New trial record
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