Efficacy and safety of revefenacin (REV), a long-acting muscarinic antagonist for nebulization: results of replicate randomized, double-blind, placebo-controlled, parallel-group phase 3 trials in participants with moderate to very severe COPD

Rationale: Prior studies demonstrated that once-daily REV doses of 88 u0026 175µg produced significant bronchodilation in COPD patients. We report the results of replicate phase 3 efficacy trials. Methods: In these 12-wk trials (NCT02459080, NCT02512510), 1255 subjects with COPD received nebulized REV 88µg (n=428), 175µg (n=425), or PBO (n=402). The primary endpoint (EP) was 24-h trough FEV 1 change from baseline to day 85. Secondary EPs included peak FEV 1 change from baseline to day 1. Labs, ECGs, and AEs were collected. Concomitant LABA or ICS/LABA therapy was allowed in 40% of subjects. Results: Baseline demographics (age 64 y; 50% male; 49% current smokers) and spirometry (post-BD FEV 1 54%, 1.32L) were similar across groups. Table 1 shows efficacy EPs. AEs (Table 2) and SAEs were similar across treatment groups. No significant findings in labs or ECGs were seen. Conclusion: Once daily nebulized revefenacin at 88 and 175µg appeared well tolerated. Improvements in trough and peak FEV 1 were clinically and statistically significant. A 12-mo study (NCT02518139) is ongoing.