Study assessments at Week 24 (ITT population)
| Placebo twice daily n=273 | Aclidinium 200 μg twice daily n=277 | Aclidinium 400 μg twice daily n=269 | |
| Change from baseline in trough FEV1 vs placebo (ml) (±SE) | – | 99*** (0.02) | 128*** (0.02) |
| Change from baseline in peak FEV1 vs placebo (ml) (±SE) | – | 185*** (0.02) | 209*** (0.02) |
| Clinically meaningful improvement (≥1 unit) in TDI focal score (% patients) | 45.5 | 53.3* | 56.9** |
| Clinically meaningful improvement (≥4 units) in SGRQ total score (% patients) | 39.5 | 54.9*** | 54.3*** |
| E-RS total score (±SE) | −0.43 (0.53) | −3.59*** (0.52) | −4.08*** (0.53) |
| Exacerbation frequency, HCRU (rate ratio vs placebo) (95% CI) | – | 0.72* (0.52 to 0.99) | 0.67* (0.48 to 0.94) |
| Exacerbation frequency, EXACT (rate ratio vs placebo) (95% CI) | – | 0.72* (0.55 to 0.94) | 0.71* (0.54 to 0.93) |
*p<0.05, **p<0.01, ***p<0.001 vs placebo.
ER-S, EXACT Respiratory Symptoms; EXACT, EXAcerbations of Chronic pulmonary disease Tool; FEV1, forced expiratory volume in 1 second; HCRU, healthcare resource utilisation; SGRQ, St George's Respiratory Questionnaire; TDI, Transition Dyspnoea Index.