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Table 1 Baseline demographics, characteristics and comorbid conditions

From: Safety and tolerability of once-daily umeclidinium/vilanterol 125/25 mcg and umeclidinium 125 mcg in patients with chronic obstructive pulmonary disease: results from a 52-week, randomized, double-blind, placebo-controlled study

 

UMEC/VI

UMEC

Placebo

Total

 

125/25 mcg

125 mcg

  
 

(n = 226)*

(n = 227)*

(n = 109)*

(n = 562)*

Age, years

    

  Mean (SD)

61.4 (9.01)

61.7 (9.10)

60.1 (8.28)

61.3 (8.92)

Sex, n (%)

    

  Female

70 (31)

82 (36)

36 (33)

188 (33)

  Male

156 (69)

145 (64)

73 (67)

374 (67)

Ethnicity, n (%)

    

  Hispanic/Latino

19 (8)

17 (7)

7 (6)

43 (8)

  Not Hispanic/Latino

207 (92)

210 (93)

102 (94)

519 (92)

Body mass index, kg/m 2

    

  Mean (SD)

27.89 (5.859)

28.05 (5.881)

27.65 (5.885)

27.91 (5.864)

Smoking pack-years∞

    

  Mean (SD)

43.7 (27.49)

39.2 (21.24)

42.8 (24.71)

41.7 (24.63)

Pre-bronchodilator FEV 1 (L)

n = 225

n = 225

n = 108

n = 558

  Mean (SD)

1.498 (0.5255)

1.432 (0.5120)

1.579 (0.5714)

1.487 (0.5311)

Post-salbutamol% predicted FEV 1 (L)

n = 224

n = 225

n = 109

n = 558

  Mean (SD)

55.0 (12.10)

54.2 (11.81)

55.1 (11.68)

54.7 (11.89)

Reversibility to salbutamol, %

n = 223

n = 224

n = 108

n = 555

  Mean (SD)

12.7 (14.83)

14.2 (18.32)

11.9 (14.89)

13.1 (16.33)

GOLD Stage, n (%)

n = 224

n = 225

n = 109

n = 558

  I (≥80% predicted FEV1)

0

0

1 (<1)

1 (<1)

  II (≥50– <80% predicted FEV1)

137 (61)

129 (57)

71 (65)

337 (60)

  III (≥30– <50% predicted FEV1)

87 (39)

96 (43)

37 (34)

220 (39)

  IV (<30% predicted FEV1)

0

0

0

0

Reversible to salbutamol, n (%) †

n = 223

n = 224

n = 108

n = 555

  Reversible

78 (35)

72 (32)

36 (33)

186 (34)

  Non-reversible

145 (65)

152 (68)

72 (67)

369 (66)

ICS use, n (%) ‡

    

  ICS users

80 (35)

73 (32)

40 (37)

193 (34)

  ICS non-users

146 (65)

154 (68)

69 (63)

369 (66)

Current medical conditions, n (%)

    

  Any condition

190 (84)

196 (86)

88 (81)

474 (84)

  Cardiovascular risk factors§

151 (67)

155 (68)

70 (64)

376 (67)

  Cardiac disorders

74 (33)

80 (35)

37 (34)

191 (34)

  Musculoskeletal and connective tissue disorders

84 (37)

64 (28)

32 (29)

180 (32)

  Metabolism and nutrition disorders

35 (15)

35 (15)

18 (17)

88 (16)

  Psychiatric disorders

33 (15)

36 (16)

15 (14)

84 (15)

  Vascular disorders

26 (12)

26 (11)

15 (14)

67 (12)

  Endocrine disorders

26 (12)

15 (7)

13 (12)

54 (10)

  Nervous system disorders

19 (8)

19 (8)

11 (10)

49 (9)

  1. *Unless otherwise specified; ∞Smoking pack-years = (number of cigarettes smoked per day/20) x number of years smoked prior to screening; †reversible was an increase in FEV1 ≥12% and ≥200 mL following administration of salbutamol; non-reversible was an increase in FEV1 of <200 mL or a ≥200 mL increase that was <12% from pre-salbutamol FEV1; ‡ICS use was defined as those patients who were currently taking ICS medications at the Screening Visit; §cardiovascular risk factors defined as current medical history of angina, myocardial infarction, stroke, diabetes, hypertension, or hyperlipidemia.
  2. FEV1, forced expiratory volume in one second; GOLD, Global initiative for chronic Obstructive Lung Disease; ICS, inhaled corticosteroid; SD, standard deviation; UMEC, umeclidinium; VI, vilanterol.
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Respiratory Research

ISSN: 1465-993X

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