Table 1.
Demographic and baseline clinical characteristics of the Japanese subgroup
| IND/GLY (n=42) | IND (n=41) | GLY (n=40) | TIO* (n=40) | Placebo (n=19) | |
|---|---|---|---|---|---|
| Age, years | 71.0 (6.92) | 69.2 (5.96) | 69.0 (8.87) | 67.8 (9.25) | 68.9 (5.22) |
| Sex, male, n (%) | 42 (100) | 40 (97.6) | 38 (95.0) | 37 (92.5) | 18 (94.7) |
| Body mass index, kg/m2 | 22.4 (3.35) | 22.7 (3.17) | 22.2 (3.05) | 22.8 (3.54) | 24.3 (1.86) |
| Smoking history, pack-years | 64.7 (25.21) | 59.9 (27.71) | 69.8 (33.36) | 64.7 (38.25) | 52.3 (20.20) |
| Smoking status, n (%) | |||||
| Ex-smoker | 31 (73.8) | 31 (75.6) | 31 (77.5) | 29 (72.5) | 17 (89.5) |
| Current smoker | 11 (26.2) | 10 (24.4) | 9 (22.5) | 11 (27.5) | 2 (10.5) |
| ICS use at baseline, n (%) | |||||
| No | 31 (73.8) | 30 (73.2) | 28 (70.0) | 29 (72.5) | 14 (73.7) |
| Yes | 11 (26.2) | 11 (26.8) | 12 (30.0) | 11 (27.5) | 5 (26.3) |
| Number of COPD exacerbations in the previous year, n (%) | |||||
| 0 | 39 (92.9) | 32 (78.0) | 31 (77.5) | 33 (82.5) | 17 (89.5) |
| 1 | 2 (4.8) | 9 (22.0) | 8 (20.0) | 7 (17.5) | 1 (5.3) |
| ≥2 | 1 (2.4) | 0 | 1 (2.5) | 0 | 1 (5.3) |
| Severity of COPD (GOLD 2008), n (%) | |||||
| Moderate COPD | 32 (76.2) | 31 (75.6) | 35 (87.5) | 28 (70.0) | 14 (73.7) |
| Severe COPD | 10 (23.8) | 10 (24.4) | 4 (10.0) | 12 (30.0) | 5 (26.3) |
| Duration of COPD, years | 3.6 (3.23) | 3.9 (5.01) | 4.0 (3.80) | 3.4 (2.10) | 3.2 (2.78) |
| FEV1, prebronchodilator, L | 1.36 (0.44) | 1.32 (0.43) | 1.35 (0.41) | 1.22 (0.42) | 1.27 (0.38) |
| FEV1, postbronchodilator, L | 1.60 (0.42) | 1.54 (0.46) | 1.56 (0.42) | 1.48 (0.45) | 1.47 (0.46) |
| FEV1 (L) postbronchodilator (% predicted FEV1) | 61.357 (13.0941) | 60.268 (14.8594) | 61.300 (11.4672) | 57.600 (12.8797) | 57.474 (13.1376) |
| FEV1 reversibility after inhalation of bronchodilator (%) | 20.167 (13.3543) | 18.829 (13.6874) | 17.000 (12.7481) | 23.800 (15.4026) | 15.737 (9.4331) |
Note: Data are represented as mean (standard deviation) unless otherwise specified.
*
Open label.
Abbreviations: IND, indacaterol; GLY, glycopyrronium; TIO, tiotropium; ICS, inhaled corticosteroid; FEV1, forced expiratory volume in 1 second; GOLD, Global Initiative for Chronic Obstructive Lung Disease.