TABLE 1

Baseline characteristics of full analysis set (n=262) at Week 12 and according to treatment arm

VariablesTotalTio/Olo 5 µg/5 µg+SMBM+ExTTio/Olo 5 µg/5 µg+SMBMTio 5 µg+SMBMPlacebo+SMBMOverall p-value
n=262n=65n=69n=64n=64
Age, years65.0±6.365.0±6.264.9±7.165.6±6.164.8±6.00.85
Sex, male gender, n (%)174 (66.4)39 (60.0)42 (60.9)48 (75.0)45 (70.3)0.195
Current smokers, n (%)96 (36.6)24 (36.9)26 (37.7)21 (32.8)25 (39.1)0.896
mMRC1.3±0.91.3±0.91.3±0.91.3±0.81.5±0.80.626
SGRQ activity55.7±19.556.0±20.055.6±21.354.7±19.456.4±17.60.954
FEV1, % predicted48.4±13.448.4±13.249.5±13.048.6±14.247.0±13.30.688
FEV1/FVC, %46.8±10.645.7±9.648.6±12.246.5±9.946.4±10.60.662
Steps per week37 684.5±19 996.938 141.6±19 210.138 253.9±21 242.936 651.3±19 455.136 602.3±20 307.70.837
Walking duration per week, min464.1±226.1466.2±216.3477.4±243.6457.1±217.7456.4±229.60.943
TSRQ autonomous regulation5.9±1.16.1±0.96.1±1.15.7±1.45.7±1.10.200
TSRQ controlled regulation3.0±1.33.0±1.33.0±1.22.9±1.23.1±1.40.962
PCS score5.4±1.45.6±1.15.6±1.25.1±1.55.1±1.50.152
Stage of change scale3.5±1.13.6±1.03.5±1.13.4±1.23.3±1.10.421
Stage of change scale (1–5), n (%)0.162
 18 (3.1)0 (0.0)3 (4.4)2 (3.1)3 (4.7)
 247 (17.9)9 (13.9)9 (13.0)18 (28.1)11 (17.2)
 378 (30.0)21 (32.3)21 (30.4)13 (20.3)23 (35.9)
 475 (28.6)19 (29.2)25 (36.2)14 (21.9)17 (26.6)
 554 (20.6)16 (24.6)11 (15.9)17 (26.6)10 (15.6)
  • Data are presented as mean±sd unless otherwise specified. ExT: exercise training; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; mMRC: modified Medical Research Council; PCS: Perceived Competence Scale; SGRQ: St George's Respiratory Questionnaire; SMBM: self-management behaviour modification; Tio: tiotropium; Tio/Olo: tiotropium/olodaterol; TSRQ: Treatment Self-Regulation Questionnaire.