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Table 2 Baseline patient demographic and clinical characteristics

From: A phase I, placebo-controlled, randomized, double-blind, single ascending dose-ranging study to evaluate the safety and tolerability of a novel biophysical bronchodilator (S-1226) administered by nebulization in healthy volunteers

 

Cohort 1

Cohort 2

Cohort 3

S-1226 (4 % CO2) (n = 9)

Placebo (n = 3)

S-1226 (8 % CO2) (n = 9)

Placebo (n = 3)

S-1226 (12 % CO2) (n = 9)

Placebo (n = 3)

Age, years

      

 Mean ± SD

35 ± 12

35 ± 11

35 ± 10

31 ± 3

33 ± 10

27 ± 11

 Median

30

36

32

32

30

23

 Range

22–55

23–45

22–51

28–34

21–45

19–39

Height, cm

      

 Mean ± SD

170.2 ± 7.1

166.7 ± 4.2

168.0 ± 10.7

171.3 ± 2.8

166.4 ± 8.8

186.0 ± 6.5

 Median

170.7

164.6

164.6

170.5

165.5

183.9

 Range

155.7–182.2

164.0–171.5

155.4–184.5

169.0–174.5

153.0–181.4

180.8–193.2

Weight, kg

      

 Mean ± SD

73.5 ± 12.4

69.4 ± 13.7

69.3 ± 13.2

67.4 ± 9.5

65.3 ± 9.1

81.3 ± 12.7

 Median

75.3

63.4

65.0

62.2

62.0

75.5

 Range

58.4–96.8

59.7–85.1

53.1–94.0

61.6–78.4

51.9–78.0

72.6–95.9

BMI, kg/m2

      

 Mean ± SD

25.3 ± 3.6

24.8 ± 3.6

24.4 ± 2.5

22.9 ± 2.4

23.6 ± 2.5

23.6 ± 4.3

 Median

26.5

23.4

24.9

21.8

23.7

22.2

 Range

20.0–29.2

22.2–28.9

19.5–28.5

21.2–25.7

19.2–26.4

20.2–28.4

Age group, years, n (%)

      

  < 18

0 (0 %)

0 (0 %)

0 (0 %)

0 (0 %)

0 (0 %)

0 (0 %)

 18–40

7 (77.8 %)

2 (66.7 %)

7 (77.8 %)

3 (100 %)

6 (66.7 %)

3 (100 %)

 41–55

2 (22.2 %)

1 (33.3 %)

2 (22.2 %)

0 (0 %)

3 (33.3 %)

0 (0 %)

Sex, n (%)

      

 Female

2 (22.2 %)

3 (100 %)

5 (55.6 %)

2 (66.7 %)

8 (88.9 %)

0 (0 %)

 Male

7 (77.8 %)

0 (0 %)

4 (44.4 %)

1 (33.3 %)

1 (11.1 %)

3 (100 %)

Ethnicity, n (%)

      

 Hispanic or Latino

2 (22.2 %)

1 (33.3 %)

3 (33.3 %)

2 (66.7 %)

4 (44.4 %)

2 (66.7 %)

 Not Hispanic or Latino

7 (77.8 %)

2 (66.7 %)

6 (66.7 %)

1 (33.3 %)

5 (55.6 %)

1 (33.3 %)

Race, n (%)

      

 Black

5 (55.6 %)

1 (33.3 %)

4 (44.4 %)

0 (0 %)

3 (33.3 %)

0 (0 %)

 Other (multiracial white and black)

0 (0 %)

1 (33.3 %)

0 (0 %)

0 (0 %)

0 (0 %)

0 (0 %)

 White

4 (44.4 %)

1 (33.3 %)

5 (55.6 %)

3 (100 %)

6 (66.7 %)

3 (100 %)

Heart rate, beats/minute, mean ± SD

66.2 ± 10.2

71.7 ± 7.5

61.9 ± 5.4

72.7 ± 9.5

72.3 ± 12.0

70.7 ± 7.4

FEV1, L/minute, mean ± SD

3.4 ± 0.7

2.8 ± 0.2

3.5 ± 1.0

3.9 ± 0.4

3.3 ± 0.7

4.9 ± 0.9

Blood pressure, mmHg,a mean ± SD

87.3 ± 8.0

89.7 ± 5.7

85.6 ± 8.0

89.2 ± 9.4

82.8 ± 9.0

87.0 ± 2.4

  1. BMI body mass index, FEV 1 forced expiratory volume in 1 second
  2. aBlood pressure values in participants were expressed as mean arterial pressures