A dose-ranging study of fluticasone furoate (FF) inhalation powder in children aged 5-11 years with asthma

Trial Profile

A dose-ranging study of fluticasone furoate (FF) inhalation powder in children aged 5-11 years with asthma

Completed
Phase of Trial: Phase II

Latest Information Update: 24 Jul 2017

At a glance

  • Drugs Fluticasone furoate (Primary) ; Fluticasone propionate
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 24 Jul 2017 According to a GlaxoSmithKline media release, based on the data from this trial the company has submitted a supplementary New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for the use of Arnuity Ellipta (fluticasone furoate) as maintenance treatment of asthma as prophylactic therapy in children aged 5 to 11 years (inclusive).
    • 01 Nov 2016 Results published in the Journal of Pediatrics
    • 09 Sep 2016 Primary endpoint (mean change from baseline in daily predose morning PEF averaged over weeks 1-12) has been met, according to results published in the Journal of Pediatrics.
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