Table 1.
Baseline demographics and patient characteristics
| Study 1222.11
|
Study 1222.12
|
|||||
|---|---|---|---|---|---|---|
| Placebo (n=209) |
Olodaterol 5 μg (n=208) |
Olodaterol 10 μg (n=207) |
Placebo (n=216) |
Olodaterol 5 μg (n=209) |
Olodaterol 10 μg (n=217) |
|
| Male, n (%) | 152 (72.7) | 150 (72.1) | 155 (74.9) | 152 (70.4) | 152 (72.7) | 152 (70.0) |
| Mean (SD) age, years | 65.8 (8.5) | 64.0 (8.6) | 65.0 (8.2) | 63.8 (8.3) | 64.7 (8.1) | 65.4 (9.7) |
| Smoking status, n (%) | ||||||
| Ex-smoker | 123 (58.9) | 133 (63.9) | 127 (61.4) | 125 (57.9) | 111 (53.1) | 125 (57.6) |
| Current smoker | 86 (41.1) | 75 (36.1) | 80 (38.6) | 91 (42.1) | 98 (46.9) | 92 (42.4) |
| Pre-bronchodilator mean (SD) FEV1,.L | 1.17 (0.45) | 1.13 (0.44) | 1.20 (0.47) | 1.20 (0.53) | 1.21 (0.47) | 1.17 (0.52) |
| Post-bronchodilator | ||||||
| Mean (SD) FEV1, L | 1.33 (0.49) | 1.32 (0.48) | 1.37 (0.49) | 1.37 (0.56) | 1.38 (0.50) | 1.32 (0.54) |
| Mean (SD)% predicted normal FEV1 | 49.1 (15.4) | 48.1 (15.4) | 49.4 (15.5) | 49.1 (16.7) | 49.2 (14.5) | 48.4 (15.4) |
| Mean (SD) FEV1/FVC, % | 45.1 (11.73) | 45.2 (12.18) | 45.5 (11.67) | 45.6 (12.35) | 46.7 (11.54) | 44.9 (11.89) |
| Mean (SD) change from pre- to post-bronchodilator FEV1, L | 0.17 (0.15) | 0.19 (0.14) | 0.17 (0.13) | 0.17 (0.15) | 0.17 (0.20) | 0.15 (0.15) |
| GOLD stage, n (%) | ||||||
| 1 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.5)a | 0 (0.0) | 1 (0.5)a |
| 2 | 101 (48.3) | 93 (44.7) | 93 (44.9) | 106 (49.1) | 103 (49.3) | 94 (43.3) |
| 3 | 83 (39.7) | 86 (41.3) | 93 (44.9) | 72 (33.3) | 84 (40.2) | 97 (44.7) |
| 4 | 25 (12.0) | 29 (13.9) | 21 (10.1) | 37 (17.1) | 22 (10.5) | 25 (11.5) |
| Baseline pulmonary medications | ||||||
| Any pulmonary medication, n (%) | 165 (78.9) | 168 (80.8) | 170 (82.1) | 159 (73.6) | 153 (73.2) | 156 (71.9) |
| SAMA,b n (%) | 42 (20.1) | 46 (22.1) | 42 (20.3) | 42 (19.4) | 29 (13.9) | 38 (17.5) |
| LAMA (tiotropium),b n (%) | 53 (25.4) | 44 (21.2) | 51 (24.6) | 38 (17.6) | 33 (15.8) | 48 (22.1) |
| SABA (inhaled),c n (%) | 102 (48.8) | 111 (53.4) | 112 (54.1) | 109 (50.5) | 106 (50.7) | 102 (47.0) |
| LABA (inhaled),d n (%) | 73 (34.9) | 72 (34.6) | 80 (38.6) | 73 (33.8) | 72 (34.4) | 75 (34.6) |
| Oral β-adrenergics, n (%) | 6 (2.9) | 4 (1.9) | 1 (0.5) | 4 (1.9) | 4 (1.9) | 6 (2.8) |
| Steroids, n (%) | ||||||
| Inhaledb | 89 (42.6) | 86 (41.3) | 93 (44.9) | 91 (42.1) | 86 (41.1) | 73 (33.6) |
| Oralb | 6 (2.9) | 12 (5.8) | 3 (1.4) | 5 (2.3) | 5 (2.4) | 5 (2.3) |
| Xanthines,b n (%) | 30 (14.4) | 29 (13.9) | 31 (15.0) | 25 (11.6) | 25 (12.0) | 21 (9.7) |
Notes:
a
Post-bronchodilator FEV1 of 82.1% and 80.0%, respectively;
b
continued during treatment period;
c
all patients were provided with salbutamol as rescue medication during the study;
d
patients permitted to switch to a SAMA for study period.
Abbreviations: SD, standard deviation; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; GOLD, Global initiative for chronic Obstructive Lung Disease; SAMA, short-acting muscarinic antagonist; LAMA, long-acting muscarinic antagonist; SABA, short-acting β2-agonist; LABA, long-acting β2-agonist.