Table 3—

Number of exacerbations per patient per year according to chronic obstructive pulmonary disease(COPD) severity and exacerbation history at baseline, and ICS use during the trial

TiotropiumPlacebop-value
COPD severity
 FEV1 >50% pred*1.21 (0.27)1.97 (0.50)<0.01
 FEV1 ≤50% pred#1.83 (0.22)2.70 (0.35)<0.05
Exacerbation history
 One exacerbation in the past yr1.24 (0.23)1.75 (0.34)ns
 Two exacerbations in the past yr+1.57 (0.21)2.19 (0.39)ns
 At least three exacerbations in the past yrƒ2.01 (0.44)3.47 (0.76)<0.001
ICS use: all exacerbation severities
 Receiving ICS§1.77 (0.25)2.50 (0.29)<0.01
 Not receiving ICS**1.24 (0.18)2.24 (0.61)ns
ICS use: moderate-to-severe exacerbations
 Receiving ICS§1.31 (0.24)1.58 (0.22)<0.01
 Not receiving ICS**0.63 (0.12)1.78 (0.58)0.06
  • Data are presented as mean (se). FEV1: forced expiratory volume in one second; % pred: percentage of predicted value; ns: nonsignificant; ICS: inhaled corticosteroids. *: n = 426; #: n = 573; : n = 393; +: n = 317; ƒ: n = 293; §: n = 615; **: n = 388.