Table 4.

Exacerbation rates stratified by concomitant ICS use (ITT population).

	Overall	ICS	No ICS
Rate of exacerbations of any severity (per patient per year)
Aclidinium 400 μg, N  =  1,356	0.41	0.54	0.32
Placebo, N  =  1,165	0.52	0.67	0.42
RR vs. placebo	0.79	0.80	0.77
p-value	0.026	0.117	0.090
Rate of moderate-to-severe exacerbations (per patient per year)
Aclidinium 400 μg, N  =  1,356	0.35	0.46	0.27
Placebo, N  =  1,165	0.44	0.57	0.35
RR vs. placebo	0.80	0.82	0.76
p-value	0.044	0.194	0.117

ICS, inhaled corticosteroid; ITT, intent-to-treat; N, number of patients; RR, rate ratio.