TABLE 1

Patient demographics and baseline characteristics (treated set)

Subjects106
Male66 (62.3)
Age years63.6±7.2
Smoking history pack-years45.6±20.7
Baseline Dyspnoea Index5.8±1.3
Post-bronchodilator lung function at screening
 FEV1 L1.561±0.525
 FEV1 % pred54.4±13.0
 GOLD stage 260 (56.6)
 GOLD stage 346 (43.4)
 FEV1 change from pre-bronchodilator L0.232±0.188
 FEV1 change from pre-bronchodilator %19.5±15.5
 FVC L3.433±1.025
 FEV1/FVC %45.8±8.9
 FRC % pred155.4±28.2
 Total lung capacity L7.3±1.5
Pulmonary medication prior to study enrolment
 Any101 (95.3)
 LABA monotherapy0 (0)
 LAMA monotherapy18 (17.0)
 LABA/ICS#7 (6.6)
 LAMA/ICS#1 (0.9)
 LAMA/LABA#18 (17.0)
 LAMA/LABA/ICS#41 (38.7)

Data are presented as n, n (%) or mean±sd. FEV1: forced expiratory volume in 1 s; GOLD: Global Initiative for Chronic Obstructive Lung Disease; FVC: forced vital capacity; FRC: functional residual capacity; LABA: long-acting β2-agonist; LAMA: long-acting muscarinic antagonist; ICS: inhaled corticosteroid. #: free or fixed-dose combination (LABA or LAMA discontinued prior to randomisation for duration of study; ICS continued if used prior to study enrolment).