Table 1.
Baseline patient demographics
| ANHELTO 1
|
ANHELTO 2
|
|||
|---|---|---|---|---|
| Tiotropium + placebo (n=565) | Olodaterol + tiotropium (n=567) | Tiotropium + placebo (n=569) | Olodaterol + tiotropium (n=566) | |
| Male, n (%) | 285 (50.4) | 279 (49.2) | 303 (53.3) | 305 (53.9) |
| Age, mean (SD), years | 64.8 (9.1) | 64.3 (9.1) | 63.6 (8.9) | 64.6 (9.0) |
| COPD diagnosis, mean (SD), years | 7.9 (6.1) | 8.5 (7.5) | 7.1 (6.3) | 8.2 (7.2) |
| Pre-bronchodilator | ||||
| FEV1, mean (SD), L | 1.251 (0.502) | 1.248 (0.490) | 1.254 (0.514) | 1.266 (0.480) |
| Post-bronchodilator | ||||
| FEV1, mean (SD), L | 1.450 (0.528) | 1.453 (0.501) | 1.442 (0.528) | 1.451 (0.497) |
| FEV1 change from pre-bronchodilator, mean (SD), L | 0.200 (0.159) | 0.205 (0.152) | 0.188 (0.166) | 0.185 (0.188) |
| FEV1/FVC, mean (SD), % | 50.1 (10.5) | 50.0 (10.7) | 50.0 (10.9) | 50.2 (10.6) |
| % of predicted normal FEV1, mean (SD) | 53.9 (13.0) | 54.2 (13.0) | 53.0 (13.9) | 53.6 (13.6) |
| GOLD, n (%) | ||||
| 1 | 0 | 0 | 0 | 0 |
| 2 | 338 (59.8) | 343 (60.5) | 317 (55.7) | 338 (59.7) |
| 3 | 227 (40.2) | 223 (39.3) | 252 (44.3) | 227 (40.1) |
| 4 | 0 | 1 (0.2) | 0 | 1 (0.2) |
| Body mass index, mean (SD), kg/m2 | 28.1 (6.8) | 28.7 (6.4) | 28.5 (6.7) | 28.3 (6.4) |
| Current smoker, n (%) | 295 (52.2) | 282 (49.7) | 274 (48.2) | 259 (45.8) |
| Smoking history, mean (SD), pack-years | 52.7 (27.1) | 54.0 (25.4) | 51.4 (26.8) | 53.9 (28.1) |
| Baseline pulmonary medications, n (%) | ||||
| Any pulmonary medications | 406 (71.9) | 399 (70.4) | 401 (70.5) | 421 (74.4) |
| SAMAa | 53 (9.4) | 49 (8.6) | 36 (6.3) | 45 (8.0) |
| LAMAa,b | 129 (22.8) | 134 (23.6) | 173 (30.4) | 158 (27.9) |
| LABAa,b | 179 (31.7) | 152 (26.8) | 183 (32.2) | 170 (30.0) |
| β-adrenergics (oral)a | 3 (0.5) | 1 (0.2) | 3 (0.5) | 1 (0.2) |
| SABAc | 257 (45.5) | 255 (45.0) | 272 (47.8) | 275 (48.6) |
| Leukotriene receptor antagonistsd | 16 (2.8) | 21 (3.7) | 18 (3.2) | 21 (3.7) |
| Mucolyticsd | 1 (0.2) | 1 (0.2) | 0 | 0 |
| Oxygen | 38 (6.7) | 42 (7.4) | 32 (5.6) | 40 (7.1) |
| Steroidsd | ||||
| Inhaled | 214 (37.9) | 203 (35.8) | 215 (37.8) | 213 (37.6) |
| Oral | 11 (1.9) | 9 (1.6) | 9 (1.6) | 6 (1.1) |
| Xanthinesd | 4 (0.7) | 1 (0.2) | 1 (0.2) | 10 (1.8) |
Notes:
a
Not permitted during treatment period
b
patients switched to study medication during treatment period
c
all patients were provided with SABA as rescue medication during this study
d
permitted during treatment period.
Abbreviations: SD, standard deviation; COPD, chronic obstructive pulmonary disease; 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; LABA, long-acting β2-agonist; SABA, short-acting β2-agonist.