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A Phase IV, 12-week, Randomised, Double-blind, Triple Dummy Study to Compare Single Inhaler Triple Therapy, Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) With Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) Based on Lung Function and Symptoms in Participants With Chronic Obstructive Pulmonary Disease

Trial Profile

A Phase IV, 12-week, Randomised, Double-blind, Triple Dummy Study to Compare Single Inhaler Triple Therapy, Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) With Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) Based on Lung Function and Symptoms in Participants With Chronic Obstructive Pulmonary Disease

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 20 May 2020

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At a glance

  • Drugs Fluticasone furoate/umeclidinium/vilanterol (Primary) ; Budesonide/formoterol; Tiotropium bromide
  • Indications Chronic obstructive pulmonary disease
  • Focus Therapeutic Use
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Research & Development
  • Most Recent Events

    • 20 May 2020 Results, pooled analysis comparing the efficacy and safety of two ICS/LAMA/LABA combinations in patients with COPD, presented at the 116th International Conference of the American Thoracic Society
    • 20 May 2020 Results assessing analysis compared measured spirometry PIFR values in a managed-care organization database (Kaiser Permanente North West [KPNW]) with a pooled patient population from two replicate studies (207608/207609) (NCT03478683/NCT03478696) presented at the 116th International Conference of the American Thoracic Society
    • 20 May 2020 Results evaluating the range of spirometry peak inspiratory flow rate observed, and any relationship between peak inspiratory flow rate and study efficacy outcomes, in a pooled patient population from two recent replicate studies (207608/207609) (NCT03478683/NCT03478696), presented at the 116th International Conference of the American Thoracic Society.
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