Table 1.
Demographic and baseline characteristics.
| Study: | Study 1 | Study 2 | ||||
|---|---|---|---|---|---|---|
| Treatment group | 360 U | 240 U | Placebo | 360 U | 240 U | Placebo |
| Total N | 37 | 35 | 36 | 54 | 53 | 48 |
| Mean age (yrs) | 58.8 | 57.7 | 59.1 | 55.5 | 55.9 | 58.0 |
| % Female | 62 | 46 | 42 | 39 | 25 | 40 |
| % Caucasian | 84 | 83 | 58 | 70 | 66 | 71 |
| Mean height (cm) | 166.3 | 169.3 | 168.9 | 171.4 | 171.5 | 171.1 |
| Baseline FVC (L), mean (range) | 2.77 (1.52–4.47) |
3.03 (1.45–6.38) |
2.96 (1.29–4.91) |
2.94 (1.30–4.87) |
3.05 (1.38–5.02) |
2.89 (1.25–4.82) |
| Baseline % predicted FVC, mean (range) | 78 (53–139) |
77 (44–127) |
76 (29–151) |
71 (47–105) |
71 (37–105) |
71 (52–108) |
| Baseline % predicted FVC, number (% of pts) | ||||||
| <40% | 0 (0%) | 0 (0%) | 1 (3%) | 0 (0%) | 1 (2%) | 0 (0%) |
| 40–60% | 5 (14%) | 4 (11%) | 3 (8%) | 10 (19%) | 7 (13%) | 10 (21%) |
| 60–80% | 16 (44%) | 18 (51%) | 20 (56%) | 33 (61%) | 31 (59%) | 27 (56%) |
| >80% | 15 (42%) | 13 (37%) | 12 (33%) | 11 (20%) | 14 (26%) | 11 (23%) |
| Baseline FEV1, mean (range) |
2.23 (1.25–3.63) |
2.47 (1.29–5.18) |
2.44 (1.23–3.94) |
2.18 (1.03–4.34) |
2.21 (0.71–3.37) |
2.11 (0.88–3.66) |
| Baseline % predicted FEV1, mean (range) | 79 (58–137) |
79 (41–130) |
80 (36–152) |
66 (46–80) |
65 (33–84) |
65 (37–100) |
| Baseline % predicted FEV1, number (% of pts) | ||||||
| <40% | 0 (0%) | 0 (0%) | 1 (3%) | 0 (0%) | 1 (2%) | 1 (2%) |
| 40–60% | 4 (11%) | 6 (17%) | 2 (6%) | 17 (32%) | 17 (32%) | 13 (27%) |
| 60–80% | 18 (50%) | 12 (34%) | 15 (42%) | 35 (65%) | 33 (62%) | 31 (65%) |
| >80% | 14 (39%) | 17 (49%) | 18 (50%) | 2 (4%) | 2 (4%) | 3 (6%) |
| FEV1/FVC ratio, mean (range) |
0.81 (0.59–0.97) |
0.82 (0.63–0.98) |
0.83 (0.59–1.20) |
0.74 (0.49–0.95) |
0.73 (0.42–0.97) |
0.74 (0.32–0.98) |