Revefenacin Area Under the Curve Spirometry in Patients with Moderate to Very Severe COPD.

PURPOSE

Several lung function endpoints are utilized in clinical trials of inhaled bronchodilators for chronic obstructive pulmonary disease (COPD). Trough forced expiratory volume in 1 second (FEV) is a commonly reported endpoint in COPD trials and can be complemented by area under the FEV vs time curve (FEV AUC), which provides information on duration and consistency of bronchodilation over a dosing interval. Revefenacin, a once-daily bronchodilator, significantly improved lung function in patients with COPD when measured by trough FEV in two replicate Phase 3 trials. Here, we report an FEV AUC substudy using data from these trials.

PATIENTS AND METHODS

This post hoc analysis examined substudy data from 12-week replicate Phase 3 trials (NCT02459080/NCT02512510); patients with moderate to very severe COPD were randomized 1:1 to revefenacin 175 μg or placebo once daily. The substudy patients had FEV AUC assessed on Day 1, and those who continued to Day 84 also underwent 24-hour serial spirometry postdose where FEV AUC AUC, AUC, and AUC were evaluated.

RESULTS

Fifty and 47 patients who received revefenacin and placebo underwent 24-hour serial spirometry; most baseline characteristics were aligned between groups. At Day 84 postdose, revefenacin demonstrated sustained improvements in bronchodilation over 24 hours; differences in least squares mean vs placebo were 282, 220, 205, and 212 mL for FEV AUC, AUC, AUC, and AUC (all <0.001), respectively.

CONCLUSION

This substudy analysis supplements previous findings that revefenacin provides sustained bronchodilation over 24 hours. Assessing additional complementary COPD clinical trial endpoints can help clinicians make treatment decisions.