Table 2. Lung function end points (ITT population).
| UMEC+ICS/LABA (N=119) | PBO+ICS/LABA (N=117) | Treatment Diff. versus PBO (95% CI) | P-value | |
|---|---|---|---|---|
| Trough FEV1 at Day 85 | n=109 | n=110 | ||
| LS mean change from baseline, ml (s.e.) | 90 (18.3) | −33 (18.4) | 123 (71, 174) | P<0.001 |
| 0–6 h weighted mean FEV1 at Day 84 | n=107 | n=110 | ||
| LS mean change from baseline, ml (s.e.) | 184 (17.6) | 35 (17.5) | 148 (99, 197) | P<0.001 |
| Proportion of patients with trough FEV1 ⩾100 ml above baseline at Day 85, n (%) | n=119 55 (46) | n=117 19 (16) | 4.8 (2.6, 9.1)a | P<0.001 |
| Proportion of patients with FEV1 increase ⩾12% and ⩾200 ml above baseline at Day 1, n (%) | n=119 67 (56) | n=117 28 (24) | 4.2 (2.4, 7.4)a | P<0.001 |
| Peak FEV1 at Day 84 | n=110 | n=110 | P<0.001 | |
| LS mean change from baseline, ml (s.e.) | 262 (18.8) | 110 (18.9) | 152 (99, 205) | |
| Trough FVC at Day 85 | n=109 | n=110 | P<0.001 | |
| LS mean change from baseline, ml (s.e.) | 99 (31.9) | −79 (32) | 177 (88, 267) | |
| Rescue use (mean puffs per day)b | n=119 | n=116 | ||
| LS mean change from baseline (s.e.) | −0.53 (0.11) | −0.15 (0.11) | −0.38 (−0.67, −0.10) | P<0.05 |
| TDI score at Day 84 | n=105 | n=109 | ||
| LS mean (s.e.) | 1.07 (0.20) | 0.67 (0.20) | 0.40 (−0.15, 0.95) | P=0.152 |
| CAT score at Day 84 | n=110 | n=110 | ||
| LS mean change from baseline (s.e.) | −0.37 (0.46) | 0.94 (0.46) | −1.31 (−2.59, −0.04) | P<0.05 |
| CAT respondersc at Day 84 | n=114 | n=112 | ||
| Responder, n (%) | 54 (47) | 30 (27) | 2.71 (1.52, 4.85)a | P<0.001 |
| SGRQ score at Day 84 | n=109 | n=106 | ||
| LS mean change from baseline (s.e.) | −2.26 (0.89) | −0.00 (0.91) | −2.26 (−4.77, 0.25) | P=0.077 |
| SGRQ respondersd at Day 84 | n=119 | n=114 | ||
| Responder, n (%) | 42 (35) | 43 (38) | 0.96 (0.56, 1.67)a | P=0.892 |
Abbreviations: CAT, COPD assessment test; CI, confidence interval; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; ICS, inhaled corticosteroid; ITT, intent-to-treat; LABA, long-acting β2-agonist; LS, least squares; PBO, placebo; SGRQ total score, calculated based on St George’s Respiratory Questionnaire for COPD patients; TDI, Transition Dyspnoea Index; UMEC, umeclidinium.
a
Odds ratio (95% CI).
b
Use over 1–12 weeks.
c
Response was defined as an improvement in CAT score of ⩾2.
d
Response was defined as a reduction from baseline of 4 units in SGRQ score; improvements in CAT scores are shown by negative changes.