Table 5.

COPD exacerbation and related hospitalizations in patients treated with tiotropium 5 μg, 10 μg, or placebo

	Tiotropium Respimat® SMI 5 μg (n = 670)	Tiotropium Respimat® SMI 10 μg (n = 667)	Placebo (n = 653)
Patients (%) with ≥1 exacerbation	37.2*	36.9*	44.1
Odds ratio† [95% CI]	0.75* [0.60, 0.93]	0.74** [0.59, 0.92]	1.00
Time (lower quartile) to first exacerbation (days)	160**	178**	86
COPD exacerbation rate (per patient year)	0.93	1.02	1.91
Mean time (%) in exacerbation§	4.0*	3.9*	5.6
Mean hospitalization‡ per patient-year	0.12	0.16	0.20
Patients (%) with ≥1 hospitalization‡	5.8	5.8	6.7

Notes:

^†Versus placebo (Chi², ie, unadjusted for extent of exposure);

^‡Due to COPD exacerbation;

^§Expressed as the mean of the percentage of days each patient remained on randomized treatment.

^*P < 0.01;

^**P < 0.001 vs placebo.

Abbreviations: COPD, chronic obstructive pulmonary disease; SMI, Soft Mist™ Inhaler.