Moderate-severe COPD: nebulized revefenacin yields improved lung function

  • Ferguson GT & al.
  • Chronic Obstr Pulm Dis
  • 09.04.2019

  • von Emily Willingham, PhD
  • Clinical Essentials
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Takeaway

  • For moderate-severe COPD, revefenacin once a day for 12 weeks yields significant trough FEV1 improvements.
  • Higher dose of 175 µg gave greater improvements in patients on concomitant long-acting beta-2 agonists.

Why this matters

  • The authors say that revefenacin has good potential to be the first once-a-day long-acting bronchodilator for patients who would do better with nebulized antimuscarinic therapy.

Key results

  • Day 85, with 88 or 175 µg, trough FEV1, respectively, improved vs placebo by:
    • First study: 79.2 (P=.0003) and 146.3 mL (P<.0001>
    • Second study: 160 and 147 mL (P<.0001>
  • Pooled results showed increases in trough FEV1 of:
    • 119.8 mL with 88 µg, and
    • 148.1 mL with 175 µg. 
  • Difference between the 2 doses was not significant.
  • Adverse event rates were similar among placebo and 2 drug doses.

Study design

  • 2 double-blind trials, 3256 patients ≥40 years randomly allocated to 1 of 2 drug doses or placebo.
  • Endpoint: 24-hour trough FEV1 on day 85.
  • Funding: Theravance Biopharma R&D, Inc. (Dublin, Ireland). 

Limitations

  • Relatively short 3-month treatment period.
  • Small subgroups.