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.