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A Randomized, Double-blind, Double-dummy, Parallel Group, Multicenter Study of Once Daily Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, Twice Daily Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Twice Daily Fluticasone Propionate 250 mcg Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents Already Adequately Controlled on Twice-daily Inhaled Corticosteroid and Long-acting beta2 Agonist

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Trial Profile

A Randomized, Double-blind, Double-dummy, Parallel Group, Multicenter Study of Once Daily Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, Twice Daily Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Twice Daily Fluticasone Propionate 250 mcg Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents Already Adequately Controlled on Twice-daily Inhaled Corticosteroid and Long-acting beta2 Agonist

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Aug 2023

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At a glance

  • Drugs Vilanterol/fluticasone furoate (Primary) ; Fluticasone propionate; Salmeterol/fluticasone propionate
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Sponsors GlaxoSmithKline; GSK

    • Most Recent Events

    • 08 Mar 2018 According to a GlaxoSmithKline media release, the European Commission has approved a label update for the use of once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI) in patients whose asthma already adequately controlled on an ICS/LABA combination.
    • 21 Jul 2017 According to a GlaxoSmithKline media release, the company has announced a submission to the EMA for the extended use of once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI) in patients already adequately controlled on an ICS/LABA combination. The submission includes data from this trial.
    • 23 Feb 2017 Primary endpoint has been met. (Change from baseline in clinic visit evening (PM) forced expiratory volume in one second (FEV1) (pre-bronchodilator and predose) at the end of the 24-week treatment period), as per the results published at a GlaxoSmithKline media release.
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