Tiotropium or salmeterol plus treatment with ICS for COPD Table 2 Median daily dose and ranges of ICS in treatment groups for patients concurrently taking ICS ICS type and median dose (μg/day) ﬂuticasone (1000) budesonide (800) % patients 41% 33% Tiotropium Salmeterol Placebo ICS dose range (μg/day) % patients ICS dose range % patients (μg/day) 100–1500 160–2400 36% 35% 220–2000 50–2400 44% 29% ICS dose range (μg/day) 100–2000 400–1800 beclomethasone (1000) 23% 200–1600 25% 100–2000 22% 100–2250 Note: Percentages do not add up to 100% because of the use of other ICS (ﬂunisolide, triamcinolone) by 2%–3% of patients in each treatment group. improvement in lung function, similar to that observed in the original study populations which included patients with and without ICS, and it is noteworthy that in the present sub-group analysis ICS did not appear to protect against the loss of bronchodilator activity over time that was observed to occur for salmeterol in the original data set (Donohue et al 2002, 2003). The ﬁndings of these two studies comparing tiotropium, salmeterol, and placebo are consistent with many published studies addressing efﬁcacy of bronchodilators in COPD and add weight to the modern concept that COPD is not necessarily a disease with ﬁxed airﬂow obstruction, but rather that COPD patients often demonstrate considerable bronchodilator response (Nisar et al 1992; Cazzola et al 1999; O’Donnell et al 2001, 2004a, b; Tashkin and Cooper 2004). Regarding dyspnea and health status in patients concurrently using ICS, in the current analysis, only those receiving tio- tropium showed statistically signiﬁcant improvement after 24 weeks on treatment, and only in the tiotropium group did these improvements reach accepted levels of clinical importance. 160 140 mL 120 100 80 mL 250 200 150 100 ** ** 15 ** ** 1 57 113 day s on treatment + ** ** ** ** ** ** ** ** + ** ** 15 57 113 day s on treatment ** ** 169 + ** ** 169 Tiotrop ium Salmeterol Tiotrop ium Salmeterol ** p<0.001 vs. placebo Figure 2a Mean trough FEV1 response of active treatment groups above placebo (patients without ICS treatment). ** p<0.001 vs. placebo + p<0.05, tiotropium vs. salmeterol Figure 2b Mean peak FEV1 response of active treatment groups above placebo (patients without ICS treatment). International Journal of COPD 2007:2(2) 163