Table 2.
Differences between treatments for primary and secondary efficacy outcomes on day 1 and at week 12 (FAS)
| Variable | LSM (95% CI) treatment difference (IND + GLY vs IND + PBO) | P-value |
|---|---|---|
| Day 1 | ||
| Trough FEV1, L | 0.074 (0.046–0.101) | <0.001 |
| Peak FEV1, L | 0.108 (0.079–0.137) | <0.001 |
| FEV1 AUC30min–4h, L | 0.106 (0.080–0.132) | <0.001 |
| Trough FVC, L | 0.111 (0.054–0.167) | <0.001 |
| IC at 30 min postdose, L | 0.059 (−0.001–0.118) | 0.054 |
| IC at 2 h postdose, L | 0.109 (0.039–0.179) | 0.003 |
| IC at 4 h postdose, L | 0.083 (0.014–0.152) | 0.019 |
| Week 12 | ||
| Trough FEV1, L (primary end point) | 0.064 (0.028–0.099) | <0.001 |
| Trough FEV1 in the PPS, L | 0.064 (0.028–0.101) | <0.001 |
| Peak FEV1, L | 0.106 (0.070–0.143) | <0.001 |
| FEV1 AUC30min–4h, L | 0.111 (0.076–0.145) | <0.001 |
| Trough FVC, L | 0.093 (0.027–0.160) | 0.006 |
| IC at 25 min predose, L | 0.081 (0.002–0.160) | 0.043 |
| IC at 30 min postdose, L | 0.159 (0.073–0.246) | <0.001 |
| IC at 2 h postdose, L | 0.122 (0.037–0.207) | 0.005 |
| IC at 4 h postdose, L | 0.138 (0.051–0.225) | 0.002 |
| IC at 24 h postdose, L | 0.068 (−0.014–0.150) | 0.105 |
| TDI focal score | 0.494 (0.030–0.958) | 0.037 |
| SGRQ-C total score | −1.47 (−3.42–0.48) | 0.140 |
| Over 12 weeks | ||
| Rescue-medication use | ||
| Change from baseline in mean daily number of puffs | −0.1 (−0.5–0.2) | 0.471 |
| Percentage of days with no rescue-medication use | 0.2 (−6.0–6.5) | 0.945 |
| Change from baseline in mean daily total symptom score | 0.0 (−0.3–0.3) | 0.810 |
| Change from baseline in mean daytime respiratory symptom score | −0.1 (−0.1–0.0) | 0.025 |
| Percentage of days able to perform usual activities | 6.2 (1.2–11.3) | 0.016 |
Note: Results of analysis in the FAS, unless otherwise stated.
Abbreviations: AUC, area under the curve; CI, confidence interval; FAS, full analysis set; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; GLY, glycopyrronium 50 μg; IC, inspiratory capacity; IND, indacaterol 150 μg; LSM, least squares mean; PBO, placebo; PPS, per protocol set; SGRQ-C, St George’s Respiratory Questionnaire – COPD; TDI, transition dyspnea index; vs, versus; COPD, chronic obstructive pulmonary disease.