| Placebo (n = 11) | SB010 (n = 12) | p-value |
---|---|---|---|
Gender [M/F] | 7/4 | 8/4 | n.s. |
Age [years] | 58.9 ± 6.9 59 (54–64) | 67.4 ± 7.9 70 (65–73) | <  0.05 |
Height [cm] | 172 ± 8 170 (167–176) | 171 ± 13 172 (160–178) | n.s. |
Weight [kg] | 76.9 ± 21.6 73.5 (61–92.4) | 75.5 ± 15.4 71.8 (66–82.5) | n.s. |
BMI [kg/m2] | 25.9 ± 6.4 25.5 (20.4–29.8) | 25.6 ± 2.7 25.2 (23.4–28.0) | n.s. |
FEV1 [l] post-bd | 1.57 (1.17–1.78) | 1.16 (0.98–1.72) | n.s. |
FEV1 [% pred.] post-bd | 51.5 ± 13 51 (40.1–60.9) | 47.5 ± 10.2 46.4 (39–55.5) | n.s. |
Reversibility (post-BD – pre-BD) [l] | 0.17 (0.13–0.37) | 0.13 (0.04–0.23) | n.s.# |
GOLD stages [II/III] | 6/5 | 4/8 | n.s. |
Current/Ex Smokers | 8/3 | 7/5 | n.s. |
Packyears | 46.1 ± 20.4 42.1 (30–70) | 53.6 ± 29.9 45 (30.8–83.5) | n.s. |
LAMA-containing regimen [%] | 63.6 | 58.3 | n.s. |
LABA-containing regimen [%] | 45.5 | 50.0 | n.s. |
ICS-containing treatment regimen [%] | 54.6 | 41.7 | n.s. |
IgEtot. [U/ml] | 75 (11–991.4) | 22.6 (9.5–51.3) | n.s. |
IgEtot. > 100 [%] | 45.5 | 16.7 | n.s. |
FeNO [ppb] | 22.0 (11.7–28.0) | 13.7 (8.5–21.7) | n.s. |
Blood eosinophils [G/l] | 0.26 ± 0.11 0.24 (0.16–0.32) | 0.28 ± 0.11 0.28 (0.21–0.36) | n.s. |
Blood eosinophils [%] | 3.5 ± 1.5 3.0 (2.2–4.9) | 4.0 ± 1.6 4.1 (3.6–5.0) | n.s. |
Sputum eosinophils [×  103/ml] | 86 (30–279) | 245 (105–552) | n.s. |
Sputum eosinophils [% non-squamous cells] | 4.6 (3.3–10.1) | 6.1 (4.2–7.9) | n.s. |