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Table 1 Baseline demographics and disease characteristics

From: Efficacy and safety of CHF6001, a novel inhaled PDE4 inhibitor in COPD: the PIONEER study

 

CHF6001

Budesonide 800 μg (N = 187)

Placebo (N = 193)

Overall (N = 1130)

400 μg BID (N = 190)

800 μg BID (N = 179)

1200 μgBID (N = 188)

1600 μg BID (N = 193)

Age (years)

64.0 (8.5)

65.2 (7.9)

65.2 (8.6)

62.9 (8.4)

64.7 (7.8)

64.5 (8.0)

64.4 (8.2)

Sex, male

133 (70.0)

129 (72.1)

131 (69.7)

135 (69.9)

132 (70.6)

133 (68.9)

793 (70.2)

Race

 Asian

0

0

0

0

1 (0.5)

0

1 (0.1)

 White

190 (100)

179 (100)

188 (100)

193 (100)

186 (99.5)

193 (100)

1129 (99.9)

BMI (kg/m2)

26.20 (4.04)

26.36 (3.64)

26.19 (4.03)

26.10 (3.98)

26.04 (3.82)

26.05 (3.73)

26.16 (3.87)

Time since COPD diagnosis (years)

8.9 (6.1)

8.6 (5.9)

9.0 (5.8)

8.3 (5.3)

9.4 (6.4)

8.7 (5.3)

8.8 (5. 8)

Main COPD phenotypea

 Chronic bronchitis only

101 (53.2)

93 (52.0)

107 (56.9)

113 (58.5)

106 (56.7)

108 (56.0)

628 (55.6)

 Emphysema only

39 (20.5)

41 (22.9)

34 (18.1)

36 (18.7)

36 (19.3)

42 (21.8)

228 (20.2)

 Mixed

50 (26.3)

45 (25.1)

47 (25.0)

44 (22.8)

45 (24.1)

43 (22.3)

274 (24.2)

Exacerbations in previous year

1.2 (0.4)

1.1 (0.4)

1.1 (0.3)

1.1 (0.4)

1.1 (0.4)

1.1 (0.4)

1.1 (0.4)

 1

160 (84.2)

157 (87.7)

164 (87.2)

173 (89.6)

161 (86.1)

174 (90.2)

989 (87.5)

 2

30 (15.8)

19 (10.6)

24 (12.8)

16 (8.3)

24 (12.8)

17 (8.8)

130 (11.5)

  > 2

0

3 (1.7)

0

4 (2.1)

2 (1.1)

2 (1.0)

11 (1.0)

Smoking history

 Pack-years

33.4 (15.4)

36.1 (15.1)

36.4 (17.5)

35.2 (15.1)

36.1 (15.0)

36.1 (14.3)

35.5 (15.4)

 Ex-smoker

91 (47.9)

85 (47.5)

97 (51.6)

77 (39.9)

82 (43.9)

100 (51.8)

532 (47.1)

 Current smoker

99 (52.1)

94 (52.5)

91 (48.4)

116 (60.1)

105 (56.1)

93 (48.2)

598 (52.9)

FEV1 (% predicted)b

48.7 (10.4)

48.6 (11.2)

47.1 (10.3)

47.9 (10.3)

48.0 (10.6)

48.1 (11.0)

48.1 (10.6)

FEV1/FVC ratiob

0.454 (0.114)

0.445 (0.109)

0.452 (0.110)

0.445 (0.098)

0.431 (0.100)

0.439 (0.095)

0.444 (0.104)

CAT total score

20.7 (5.1)

20.6 (5.5)

21.0 (4.9)

20.4 (5.0)

20.4 (5.1)

20.2 (5.0)

20.5 (5.1)

mMRC score

2.4 (0.5)

2.4 (0.5)

2.4 (0.5)

2.3 (0.5)

2.3 (0.5)

2.3 (0.5)

2.3 (0.5)

  1. Data are mean (SD) or number (%). aAs assessed by the investigator. bPost-bronchodilator. BID twice daily, BMI body mass index, COPD chronic obstructive pulmonary disease, FEV1 forced expiratory volume in 1 s, FVC forced vital capacity, CAT COPD Assessment Test, mMRC modified Medical Research Council dyspnoea scale