Table 5.
Lung function tests: change from baseline in FEV1, FVC, and FEF25%–75% in patients with moderate or severe COPD following administration of Lumason®.
| Change from baseline post-injection at: | Lumason®—Placebo | |||
|---|---|---|---|---|
| Mean | SD | 95% CIb | ||
| FEV1(ml) | 1 min | 1.9 | 193.54 | −121.1, 124.9 |
| 3 min | 25.2 | 255.41 | −137.1, 187.4 | |
| 9 min | −60.9 | 174.83 | −172.0, 50.2 | |
| 10 min | −34.6 | 146.64 | −127.8, 58.6 | |
| 11 min | −42.4 | 199.51 | −169.2, 84.3 | |
| FVC (ml) | 9 min | −103.7 | 278.22 | −280.4, 73.1 |
| 10 min | −73.9 | 265.94 | −242.9, 95.1 | |
| 11 min | −97.0 | 359.80 | −325.6, 131.6 | |
| FEF25%–75% (L/s) | 9 min | 10.2 | 75.23 | −37.6, 58.0 |
| 10 min | 5.6 | 125.44 | −74.1, 85.3 | |
| 11 min | 12.4 | 140.24 | −76.7, 101.5 | |
n = 12 for all assessments.
Taken from Reference (31).
FEV1, indicates forced expiratory volume; FVC, forced vital capacity; FEF, forced mid-expiratory flow; CI, confidence interval.
Difference between Lumason® (SonoVue™) and placebo in the change from baseline in FEV1, FVC, or FEF25%–75%.
Based on a comparison between Lumason® (SonoVue™) and placebo in the change from baseline in FEV1 by using a paired t-test.