Table 1.
Baseline demographics, characteristics and comorbid conditions
| |
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) |
*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.
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.