Table 1.
Patient baseline demographic and asthma characteristics, Full Analysis Set
|
Characteristic |
Treatment group |
||||
|---|---|---|---|---|---|
| Fluticasone/formoterol 100/10 μg b.i.d. N = 115 | Fluticasone 100 μg b.i.d. N = 117 | Formoterol 10 μg b.i.d. N = 116 | Placebo b.i.d. N = 111 | Overall N = 459 | |
|
Gender, n (%) |
|
|
|
|
|
| Female |
72 (62.6) |
71 (60.7) |
63 (54.3) |
70 (63.1) |
276 (60.1) |
| Male |
43 (37.4) |
46 (39.3) |
53 (45.7) |
41 (36.9) |
183 (39.9) |
|
Ethnic origin, n (%) | |||||
| White/Caucasian |
89 (77.4) |
88 (75.2) |
83 (71.6) |
79 (71.2) |
339 (73.9) |
| Black |
13 (11.3) |
16 (13.7) |
21 (18.1) |
22 (19.8) |
72 (15.7) |
| Asian |
6 (5.2) |
4 (3.4) |
5 (4.3) |
4 (3.6) |
19 (4.1) |
| Hispanic |
6 (5.2) |
8 (6.8) |
6 (5.2) |
5 (4.5) |
25 (5.4) |
| Other |
1 (0.9) |
1 (0.9) |
1 (0.9) |
1 (0.9) |
4 (0.9) |
|
Age, years |
|
|
|
|
|
| Mean (SD) |
39.8 (14.54) |
38.3 (14.45) |
39.1 (15.26) |
38.1 (13.67) |
38.8 (14.47) |
|
Age categories, n (%) | |||||
| 12 to 17 years |
7 (6.1) |
9 (7.7) |
9 (7.8) |
6 (5.4) |
31 (6.8) |
| ≥ 18 years |
108 (93.9) |
108 (92.3) |
107 (92.2) |
105 (94.6) |
428 (93.2) |
|
Steroid use, n (%) |
|
|
|
|
|
| Freea |
59 (51.3) |
60 (51.3) |
58 (50.0) |
55 (49.5) |
232 (50.5) |
| Requiringb |
56 (48.7) |
57 (48.7) |
58 (50.0) |
56 (50.5) |
227 (49.5) |
|
Prior ICS and ICS/LABA use, n (%) | |||||
| ICS only |
31 (27.0) |
39 (33.3) |
30 (25.9) |
35 (31.5) |
135 (29.4) |
| ICS and LABA |
25 (21.7) |
18 (15.4) |
28 (24.1) |
21 (18.9) |
92 (20.0) |
|
Duration of asthma, yearsc | |||||
| Mean (SD) |
18.9 (13.40) |
20.6 (13.84) |
20.3 (14.48) |
21.4 (12.83) |
20.3 (13.64) |
|
FEV1 % predictedd at baselinee | |||||
| Mean (SD) |
73.2 (7.54) |
73.5 (8.14) |
73.2 (7.79) |
72.0 (7.97) |
73.0 (7.86) |
| Median |
72.0 |
75.0 |
73.0 |
72.0 |
73.0 |
| FEV1 at baselinee, L | |||||
| Mean (SD) |
2.416 (0.5790) |
2.425 (0.6625) |
2.459 (0.6231) |
2.352 (0.6114) |
2.414 (0.6192) |
| Median |
2.370 |
2.330 |
2.375 |
2.250 |
2.340 |
|
Reversibility at screening, % | |||||
| |
n = 114 |
n = 117 |
n = 116 |
n = 111 |
n = 458 |
| Mean (SD) |
23.2 (10.1) |
22.8 (9.0) |
21.8 (8.4) |
22.8 (8.3) |
22.6 (9.0) |
| Median | 19.3 | 19.5 | 18.7 | 20.0 | 19.2 |
N = total number of patients; n = number of patients in specified category; SD = standard deviation; b.i.d. = twice daily; ICS = inhaled corticosteroids; LABA = long acting beta agonist; FEV1 = Forced Expiratory Volume in the first second.
a. Patient with no history of steroid use for at least 12 weeks prior to the screening visit.
b. Patient who used an inhaled steroid regimen at a dose not greater than 500 μg/day fluticasone (or equivalent steroid) for at least 4 weeks prior to screening.
c. Duration of asthma calculated as (Date of screening visit from Demographics CRF - Asthma diagnosis date)/ 365.25 and rounded to 1 decimal place.
d. Based on standardised predicted FEV1 values.
e. Baseline was the last available value prior to dosing at the baseline/week 0 visit.