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A Phase 4, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Study Comparing Improvements in Lung Function in Adults With Severe to Very Severe Chronic Obstructive Pulmonary Disease and Suboptimal Inspiratory Flow Rate Following Once-Daily Treatment Over 12 Weeks With Either Revefenacin Inhalation Solution Delivered Via Standard Jet Nebulizer or Tiotropium Delivered Via a Dry Powder Inhaler (Spiriva HandiHaler)

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Trial Profile

A Phase 4, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Study Comparing Improvements in Lung Function in Adults With Severe to Very Severe Chronic Obstructive Pulmonary Disease and Suboptimal Inspiratory Flow Rate Following Once-Daily Treatment Over 12 Weeks With Either Revefenacin Inhalation Solution Delivered Via Standard Jet Nebulizer or Tiotropium Delivered Via a Dry Powder Inhaler (Spiriva HandiHaler)

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 10 Jan 2024

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At a glance

  • Drugs Revefenacin (Primary) ; Tiotropium bromide (Primary)
  • Indications Chronic obstructive pulmonary disease
  • Focus Therapeutic Use
  • Acronyms PIFR-2
  • Sponsors Theravance Biopharma

    • Most Recent Events

    • 05 Jan 2024 According to a Theravance Biopharma Media Release, company is looking forward to share additional details from PIFR-2 in the future, following additional data analyses.
    • 05 Jan 2024 Primary endpoint (change from baseline in trough forced expiratory volume in one second (FEV1) at Day 85) has not been met, according to a Theravance Biopharma Media Release.
    • 05 Jan 2024 Results presented in a Theravance Biopharma Media Release.

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