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. 2013 Feb 21;42(4):972–981. doi: 10.1183/09031936.00165712

Table 1– Patient demographics and clinical characteristics at screening.

Placebo Salmeterol GSK961081
Twice daily Once daily
100 μg 200 μg 400 μg 100 μg 400 μg 800 μg
ITT subjects n 81 47 52 50 54 50 50 52
Age years 63±7 61±7 62±9 61±9 63±8 63±9 62±8 61±9
Male % 70 62 71 64 70 64 52 67
BMI kg·m−2 26±4 26±4 26±4 26±4 26±4 26±4 27±4 26±4
Current smoker % 44 62 54 66 46 40 54 48
Concurrent ICS use % 59 55 58 60 56 60 54 56
Reversible to salbutamol# % 33 36 33 34 37 32 26 31
FEV1 L 1.56±0.53 1.48±0.47 1.55±0.50 1.59±0.46 1.62±0.47 1.63±0.49 1.53±0.45 1.56±0.42
FEV1 % pred 49±11 48±10 50±10 51±10 51±10 53±10 52±10 51±10
FEV1 % reversibility 12±11 12±16 12±14 13±13 14±11 11±12 12±12 13±13
FEV1/FVC ratio 0.49±0.10 0.50±0.10 0.51±0.09 0.50±0.09 0.50±0.10 0.50±0.10 0.52±0.10 0.51±0.09

Data are presented as mean±sd, unless otherwise stated. ITT: intent-to-treat; BMI: body mass index; ICS: inhaled corticosteroid; FEV1: forced expiratory volume in 1 s; % pred: % predicted; FVC: forced vital capacity. #: reversibility to salbutamol defined as increase in FEV1 of 200 mL and 12% following salbutamol administration; : post-salbutamol measurements.