TABLE 4.
Patient characteristics at screening
| Completers | Drop outs | P | |
|---|---|---|---|
| Total randomized, n | 694 | 219 | |
| Male, % | 61 | 57 | 0.3444 |
| Age, years | 66.3±8.8 | 68.4±8.7 | 0.0028 |
| Duration of COPD, years | 9.8±8.2 | 10.3±7.5 | 0.4827 |
| Smoking history, pack-years | 49.3±23.2 | 54.0±25.7 | 0.0108 |
| Current smoker, % | 33 | 26 | 0.0367 |
| FEV1, L | 0.99±0.38 | 0.86±0.37 | <0.0001 |
| FEV1, % predicted | 40.2±13.3 | 36.5±13.7 | 0.0004 |
| FVC, L | 2.16±0.74 | 1.96±0.74 | 0.0004 |
| FEV6, L* | 2.02±0.61 | 1.59±0.48 | 0.0015 |
| FEV1/FVC, % | 46.8±11.6 | 44.7±11.8 | 0.0180 |
| Respiratory medication use, n (%) | |||
| Any pulmonary medication | 602 (86.7) | 201 (91.8) | 0.0561 |
| Anticholinergic | 387 (55.8) | 157 (71.7) | <0.0001 |
| Beta2-agonist, oral | 1 (0.1) | 0 (0.0) | 1.0000 |
| Short-acting beta2-agonist, inhaled | 444 (64.0) | 158 (72.1) | 0.0273 |
| Long-acting beta2-agonist, inhaled | 361 (52.0) | 130 (59.4) | 0.0622 |
| Leukotriene receptor antagonist | 5 (0.7) | 7 (3.2) | 0.0108 |
| Theophyllines | 59 (8.5) | 31 (14.2) | 0.0188 |
| Steroids, inhaled | 454 (65.4) | 163 (74.4) | 0.0131 |
| Steroids, oral | 16 (2.3) | 18 (8.2) | 0.0003 |
| Oxygen | 42 (6.1) | 24 (11.0) | 0.0237 |
Data are presented as mean ± SD unless otherwise indicated.
*
Forced expiratory volume in 6 s (FEV6) was only measured at qualified sites, and includes 95 completers and 24 drop outs. COPD Chronic obstructive pulmonary disease; FEV1 Forced expiratory volume in 1 s; FVC Forced vital capacity