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Table 2 Patient demographics and baseline characteristics (safety population)

From: Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study

 

Placebo

FDC

FDC

Aclidinium

Formoterol

Total

400/12 μg

400/6 μg

400 μg

12 μg

Patients, n

194

385

381

385

384

1729

Age, years

64.2 ± 8.0

62.7 ± 8.1

62.9 ± 7.7

63.1 ± 8.2

63.4 ± 7.8

63.2 ± 8.0

Males, n (%)

138 (71.1)

261 (67.8)

259 (68.0)

256 (66.5)

255 (66.4)

1169 (67.6)

Caucasians, n (%)

183 (94.3)

367 (95.3)

366 (96.1)

363 (94.3)

362 (94.3)

1641 (94.9)

Current smoker, n (%)

94 (48.5)

181 (47.0)

182 (47.8)

182 (47.3)

179 (46.6)

818 (47.3)

Severity of airflow obstruction, n (%), based on GOLD 2010 criteriaa

     

  Moderate

116 (60.1)

229 (59.5)

230 (60.4)

226 (58.9)

237 (61.9)

1038 (60.1)

  Severe

77 (39.9)

156 (40.5)

151 (39.6)

157 (40.9)

144 (37.6)

685 (39.7)

Baseline FEV1, L

1.42 ± 0.54

1.42 ± 0.49

1.41 ± 0.48

1.40 ± 0.51

1.40 ± 0.48

1.41 ± 0.50

Post-bronchodilator FEV1, % predicted

55.0 ± 13.4

54.6 ± 13.1

54.1 ± 13.0

53.6 ± 13.0

54.5 ± 13.2

54.3 ± 13.1

Patients meeting bronchial reversibility criteria, n (%)b

66 (34.0)

134 (34.8)

127 (33.3)

125 (32.6)

114 (29.8)

566 (32.8)

Prior COPD medication, n (%)

     

  Any COPD-related medication

167 (86.1)

330 (85.7)

331 (86.9)

337 (87.5)

329 (85.7)

1494 (86.4)

  LABA + ICSc

63 (32.5)

118 (30.6)

128 (33.6)

121 (31.4)

119 (31.0)

549 (31.8)

  LAMA

60 (30.9)

118 (30.6)

122 (32.0)

107 (27.8)

110 (28.6)

517 (29.9)

  LABA

38 (19.6)

79 (20.5)

69 (18.1)

78 (20.3)

80 (20.8)

344 (19.9)

  ICS

39 (20.1)

85 (22.1)

72 (18.9)

79 (20.5)

68 (17.7)

343 (19.8)

BDI focal score

6.6 ± 2.0

6.6 ± 2.1

6.6 ± 2.0

6.5 ± 2.0

6.5 ± 2.1

6.5 ± 2.1

SGRQ total score

45.8 ± 17.6

46.1 ± 17.9

46.7 ± 17.6

46.8 ± 16.8

45.2 ± 18.2

46.2 ± 17.6

  1. aOne patient randomised to formoterol 12 μg had mild COPD at baseline; one patient each randomised to formoterol 12 μg and aclidinium 400 μg had very severe COPD at baseline; bBronchial reversibility ≥12% and change in FEV1 from pre-test ≥200 mL; cLABA and ICS in fixed-dose combination.
  2. Data are presented as mean ± SD, unless otherwise stated.
  3. BDI, Baseline Dyspnoea Index; COPD, chronic obstructive pulmonary disease; FDC, aclidinium/formoterol fixed-dose combination; FEV1, forced expiratory volume in 1 second; GOLD, Global Initiative for Chronic Obstructive Lung Disease; ICS, inhaled corticosteroid; LABA, long-acting β2-adrenergic agonist; LAMA, long-acting muscarinic antagonist; SD, standard deviation; SGRQ, St George’s Respiratory Questionnaire.