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A Randomized, Double-blind, Repeat Dose, Two Period Crossover Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Inhaled Fluticasone Furoate/Vilanterol 100/25 Micrograms in Children Aged 5 to 11 Years With Persistent Asthma.

Trial Profile

A Randomized, Double-blind, Repeat Dose, Two Period Crossover Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Inhaled Fluticasone Furoate/Vilanterol 100/25 Micrograms in Children Aged 5 to 11 Years With Persistent Asthma.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 31 Oct 2023

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At a glance

  • Drugs Vilanterol/fluticasone furoate (Primary) ; Fluticasone furoate
  • Indications Asthma
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors GlaxoSmithKline; GSK
  • Most Recent Events

    • 12 Sep 2023 Results from (HZA102942,HZA112776 and HZA112777) and two Phase 2b(HZA106855 and HZA106853) assessing compare model-predicted steady-state maximumplasma concentrations (Cmax) and overall systemicexposure (AUC0-24) of FF and VI in pediatric Japaneseand non-Japanese population subgroups presented at the 2023 American College of Clinical Pharmacology Annual Meeting
    • 29 Apr 2014 Results published in the Clinical Therapeutics.
    • 01 Jun 2012 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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