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SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects With Asthma

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Trial Profile

SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects With Asthma

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 05 Sep 2023

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At a glance

  • Drugs Salmeterol/fluticasone propionate (Primary) ; Fluticasone propionate
  • Indications Asthma
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms AUSTRI
  • Sponsors GlaxoSmithKline; GSK
  • Most Recent Events

    • 20 Dec 2017 According to a GlaxoSmithKline media release, based on the data from four trials (including AUSTRI, SAS115359 and VESTRI, SAS115358) submitted by three companie, the US Food and Drug Administration (FDA) has approved labelling changes to remove the boxed warning from inhaled corticosteroid (ICS) / long-acting beta2 agonist (LABA) combination medicines, including BREO ELLIPTA (fluticasone furoate/vilanterol, FF/VI), ADVAIR DISKUS (fluticasone propionate/salmeterol, FSC) and ADVAIR HFA.
    • 20 Dec 2017 The FDA also approved updates to the Warnings and Precautions section of labelling for the ICS/LABA class, according to a GlaxoSmithKline media release.
    • 07 Mar 2016 Results presented at the 2016 Annual Meeting of the American Academy of Allergy, Asthma and Immunology
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