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Table 1 Baseline characteristics of the intention-to-treat population

From: A GATA3-specific DNAzyme attenuates sputum eosinophilia in eosinophilic COPD patients: a feasibility randomized clinical trial

 

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.

  1. Data are displayed as mean ± SD in the upper row, median (25% – 75%) in the lower row. For variables not normally distributed in at least one group, data are displayed as median (25% percentile – 75% percentile). Categorical variables are displayed as absolute numbers or percentage as indicated. P values were calculated using the exact Wilcoxon two-sample test for continuous variables and Fisher’s exact test for categorical variables As tests for normality of residuals were based on a small sample size, the t test was also performed for each continuous variable yielding the same result with regard to statistical significance except for reversibility. FeNO: Fraction of exhaled nitric oxide (at 50 ml/s flow-rate); LABA Long acting beta-2-receptor agonist, LAMA Long acting muscarinic acetylcholine-receptor antagonist, ppb Parts per billion, ICS Inhaled corticosteroid, n.s Not significant. # p < 0.05 tested with two-sample t test