Moderate-severe COPD: nebulized revefenacin yields improved lung function

  • Ferguson GT & al.
  • Chronic Obstr Pulm Dis
  • 9 Apr 2019

  • International Clinical Digest
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

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.