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Table 1 Patient demographics and baseline characteristics for the pooled ACLIFORM and AUGMENT studies

From: Aclidinium bromide and formoterol fumarate as a fixed-dose combination in COPD: pooled analysis of symptoms and exacerbations from two six-month, multicentre, randomised studies (ACLIFORM and AUGMENT)

  FDC 400/12 μg (n = 720) Aclidinium 400 μg (n = 720) Formoterol 12 μg (n = 715) Placebo (n = 525)
Age, years 63.4 ± 8.5 63.7 ± 8.5 63.5 ± 8.2 63.7 ± 8.6
Gender, male, n (%) 429 (59.6) 442 (61.4) 423 (59.2) 313 (59.6)
Current smoker, n (%) 354 (49.2) 351 (48.8) 350 (49.0) 263 (50.1)
FEV1, L 1.4 ± 0.5 1.4 ± 0.5 1.4 ± 0.5 1.4 ± 0.6
Post-bronchodilator FEV1, % predicted 53.9 ± 13.2 53.3 ± 13.1 54.2 ± 13.1 53.5 ± 13.4
Number of exacerbations in previous 12 months 0.5 (0.9) 0.5 (0.8) 0.4 (0.8) 0.3 (0.7)
Prior COPD medicationa, n (%)     
 Any COPD medication 576 (80.0) 591 (82.1) 574 (80.3) 411 (78.3)
 LABA + ICS 210 (29.2) 234 (32.5) 222 (31.0) 172 (32.8)
 LAMA 209 (29.0) 190 (26.4) 181 (25.3) 141 (26.9)
 ICS 114 (15.8) 106 (14.7) 96 (13.4) 62 (11.8)
 LABA 85 (11.8) 81 (11.3) 92 (12.9) 42 (8.0)
BDI focal score 6.4 ± 2.1 6.5 ± 2.1 6.4 ± 2.2 6.5 ± 2.2
E-RS total scoreb 12.9 ± 6.8 12.5 ± 6.4 12.3 ± 6.6 12.2 ± 6.3
Overall night-time COPD symptom severity scorec 1.1 ± 0.7 1.1 ± 0.7 1.1 ± 0.7 1.1 ± 0.7
Overall early-morning COPD symptom severity scorec 1.3 ± 0.7 1.3 ± 0.7 1.2 ± 0.7 1.2 ± 0.6
GOLD group, n (%)     
 A 62 (8.8) 51 (7.3) 74 (10.6) 48 (9.4)
 B 320 (45.5) 322 (46.0) 327 (46.7) 224 (43.7)
 C 16 (2.3) 27 (3.9) 16 (2.3) 17 (3.3)
 D 305 (43.4) 300 (42.9) 283 (40.4) 224 (43.7)
  1. Data are presented as mean ± standard deviation for the pooled ITT population, unless otherwise stated
  2. BDI Baseline Dyspnoea Index, COPD chronic obstructive pulmonary disease, E-RS EXAcerbations of Chronic obstructive pulmonary disease Tool (EXACT)-Respiratory Symptoms questionnaire, FDC aclidinium/formoterol fixed-dose combination, FEV 1 forced expiratory volume in 1 s, ICS inhaled corticosteroid, ITT intent-to-treat, LABA long-acting β2-agonist, LAMA long-acting muscarinic antagonist
  3. aPatients can be included in multiple categories
  4. bE-RS total scores range from 0 to 40 with higher scores indicating more severe symptoms
  5. cNight-time and early-morning symptom scores range from 0 (no symptoms) to 4 (very severe symptoms)