Hodder et al Table 1 Patient characteristics at baseline (a) Patient characteristics (ICS users) at baseline (mean [SD]) (b) Patient characteristics (ICS nonusers) at baseline (mean [SD]) N Mean age (yrs) Male (%) Current smokers (%) Smoking history (pack years) FEV1 (L) FEV1 (%predicted)a FVC (L) BDI (0–12) SGRQ (Total) (0–100) a(Morris 1998). N Mean age (yrs) Male (%) Current smokers (%) Smoking history (pack years) FEV1 (L) FEV1 (%predicted)a FVC (L) BDI (0–12) SGRQ (Total) (0–100) a(Morris 1998). Tiotropium 259 64 (8) 79 41 43 (23) 1.08 (0.37) 39 (12) 2.53 (0.71) 6.3 (2.2) 47 (17) Tiotropium 135 64 (8) 74 46 46 (22) 1.18 (0.41) 43 (13) 2.63 (0.78) 6.7 (2.4) 42 (16) Salmeterol 278 64 (8) 76 29 44 (24) 1.03 (0.39) 38 (13) 2.51 (0.78) 6.2 (2.3) 47 (17) Salmeterol 120 65 (8) 73 52 47 (24) 1.14 (0.39) 42 (12) 2.61 (0.73) 7.1 (2.2) 40 (17) Placebo 259 65 (8) 78 36 41 (23) 1.09 (0.40) 40 (13) 2.60 (0.80) 6.3 (2.2) 46 (16) Placebo 135 64 (9) 73 53 46 (23) 1.07 (0.38) 40 (13) 2.48 (0.73) 6.9 (2.4) 43 (18) Safety A safety summary of the two studies was published previ- ously (Brusasco et al 2003). Both active treatments were well tolerated, with dry mouth the predominant adverse event reported in 8% of patients receiving tiotropium (salmeterol and placebo 2%, each). Discussion A pooled analysis from two studies comparing the long- acting anticholinergic tiotropium to the long-acting beta2- adrenergic salmeterol in patients with COPD had previously demonstrated a sustained and superior improvement in lung function with tiotropium 18 μg once-daily compared to salmeterol 50 μg twice-daily regardless of concurrent use of ICS (Brusasco et al 2003; Donohue et al 2002, 2003). In these two studies, 66% of the patients enrolled had been prescribed ICS on a regular basis, providing the opportunity to retrospectively analyze the relative efﬁcacy of tiotropium and salmeterol as a function of the concomitant use of ICS in patients with moderately advanced COPD. In patients with moderate-to-severe COPD, our present post-hoc analysis demonstrated superior spirometric responses with tiotropium plus ICS compared to salmeterol plus ICS. Both long-acting bronchodilators demonstrated an 162 International Journal of COPD 2007:2(2)