| |
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)
|
- Data are presented as mean ± standard deviation for the pooled ITT population, unless otherwise stated
-
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
-
aPatients can be included in multiple categories
-
bE-RS total scores range from 0 to 40 with higher scores indicating more severe symptoms
-
cNight-time and early-morning symptom scores range from 0 (no symptoms) to 4 (very severe symptoms)
