Background
Methods
Study design and study population
Assessments
Statistical analysis
Results
Study population
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. |
Exploratory efficacy analyses
Placebo (n = 10) | SB010 (n = 9) | |||||
---|---|---|---|---|---|---|
Screening | d29 | p-value | Screening | d29 | p-value | |
Absolute cell counts [× 103/ml] | ||||||
Total cell count | 2854 ± 3259 2154 (935–3104) | 3334 ± 2156 2691 (1712–4233) | 0.27 | 6207 ± 7229 3509 (1782–7288) | 6845 ± 5432 5628 (3684–6279) | 1.00 |
Alevolar Macrophages | 508 ± 555 312 (165–473) | 509 ± 369 387 (263–721) | 0.42 | 775 ± 711 539 (188–1040) | 862 ± 808 611 (460–831) | 0.65 |
Eosinophils | 202 ± 225 88 (30–279) | 174 ± 212 88 (22–206) | 0.54 | 704 ± 1011 347 (107–544) | 196 ± 134 192 (121–234) | 0.06 |
Neutrophils | 2083 ± 3160 1004 (464–2496) | 2596 ± 1907 2048 (1166–3345) | 0.08 | 4556 ± 6876 1828 (1429–4491) | 5642 ± 5590 3366 (2828–5398) | 0.65 |
Lymphocytes | 20.3 ± 20.5 14 (8–29) | 13.5 ± 17.6 9 (0–22) | 0.84 | 29.6 ± 37.5 20 (8–29) | 35 ± 45.7 16 (3–36) | 0.73 |
Monocytes | 4.6 ± 6.8 1 (0–10) | 5.2 ± 4.5 4.5 (2–9) | 0.73 | 6.8 ± 9.1 2 (0–9) | 19.3 ± 37.9 0 (0–11) | 0.80 |
Relative cell counts [% non-squamous cell] | ||||||
Alevolar Macrophages | 23.8 ± 20.1 17.7 (8.4–41.7) | 16.7 ± 9.4 14.2 (9.6–25.4) | 0.49 | 19.8 ± 16.4 15.4 (11.2–21.9) | 17.7 ± 14.6 14.8 (7.3–24.2) | 0.57 |
Eosinophils | 7.2 ± 4.9 5 (3.6–10.1) | 6.4 ± 9.2 2 (1–7.1) | 0.38 | 10.7 ± 12.3 6.5 (6–8) | 4.4 ± 5.4 2.7 (1.4–4) | 0.004 |
Neutrophils | 65.2 ± 23.2 70.2 (49.6–82) | 74.5 ± 18.1 82.1 (68.1–85.8) | 0.13 | 65.2 ± 26.3 73.7 (66.6–80.2) | 74.8 ± 17.9 80.6 (70.7–86) | 0.10# |
Lymphocytes | 0.88 ± 0.78 0.75 (0.3–1.6) | 0.4 ± 0.36 0.4 (0–0.5) | 0.17 | 0.68 ± 0.58 0.6 (0.1–1) | 0.62 ± 0.68 0.6 (0.1–0.8) | 1.0 |
Monocytes | 0.23 ± 0.33 0.05 (0–0.3) | 0.14 ± 0.15 0.1 (0.1–0.1) | 0.87 | 0.22 ± 0.39 0.1 (0–0.1) | 0.38 ± 0.78 0 (0–0.4) | 0.90 |