Table 3.
Change from Baseline to Week 4 in Peak FEV1 (Over 3 Hours), Average FEV1 (0–12 Hours) and Morning Trough FEV1 in the Full Analysis Set
| Ensifentrine Treatment Arm† (n) | |||||
|---|---|---|---|---|---|
| 0.375 mg Arm (n=83) | 0.75 mg Arm (n=83) | 1.5 mg Arm (n=81) | 3 mg Arm (n=82) | Placebo Arm (n=84) | |
| Week 4 Peak FEV1 (0–3h) (change from baseline) | |||||
| LS mean, mL (95% CI) | 196 (144, 248) | 210 (157, 263) | 226 (174, 278) | 243 (191, 295) | 119 (68, 170) |
| Treatment – placebo difference, LS mean, mL (95% CI) | 78 (5, 150) | 91 (18, 164) | 107 (34, 180) | 124 (52, 197) | |
| p-value | 0.037 | 0.015 | 0.004 | 0.001 | |
| Week 4 Average FEV1 (0–12h) (change from baseline) | |||||
| LS mean, mL (95% CI) | 36 (−12, 84) | 63 (14, 112) | 64 (16, 112) | 97 (49, 145) | 10 (−38, 57) |
| Treatment – placebo difference, LS mean, mL (95% CI) | 26 (−41, 94) | 53 (−15, 121) | 54 (−13, 122) | 87 (20, 155) | |
| p-value | 0.446 | 0.124 | 0.115 | 0.011 | |
| Week 4 Morning trough FEV1 (change from baseline) | |||||
| LS mean, mL (95% CI) | −20 (−65, 25) | −35 (−81, 12) | −14 (−60, 31) | 5 (−40, 51) | −22 (−66, 23) |
| Treatment – placebo difference, LS mean, mL (95% CI) | 2 (−62, 65) | −13 (−77, 51) | 8 (−56, 71) | 27 (−36, 91) | |
| p-value | 0.959 | 0.691 | 0.812 | 0.400 | |
Notes: Data are least squares mean treatment – placebo differences, both added on to tiotropium (95% CI); p-value (p<0.05 is significant). †Double-blind study medication (ensifentrine 0.375, 0.75, 1.5 or 3 mg or placebo BID) added to once-daily tiotropium QD. Baseline, post 2 weeks receiving tiotropium.
Abbreviations: BID, twice daily; CI, confidence interval; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 second; LS, least squares; n, number of patients in full analysis set; placebo, ensifentrine placebo added to tiotropium; QD, once daily.