Table 1.
BDP/F 400/24 μg/day (N = 206) |
FP/S 500/100 μg/day (N = 216) |
||
---|---|---|---|
Age (years) |
|
44 (13) |
44 (13) |
Gender |
Male |
69 (33.5%) |
77 (35.6%) |
|
Female |
137 (66.5%) |
139 (64.4%) |
BMI (kg/m2) |
|
27.1 (5.1) |
27.0 (5.2) |
Device used before screening |
pMDI |
12.6% |
12.6% |
|
DPI |
87.4% |
87.4% |
Years from asthma diagnosis |
|
11 (10) |
13 (11) |
FEV1, L |
|
2.9 (0.9) |
3.0 (0.8) |
FEV1% predicted |
|
86.9 (15.1) |
88.3 (14.1) |
PEF, L/min |
|
435.7 (8.3) |
452.9 (8.1) |
PEF % predicted |
|
97.8 (21.4) |
100.5 (20.3) |
Number of days/week with symptomsa |
|
0.5 (1.2) |
0.3 (0.6) |
Number of nights/week with symptomsa |
|
0.3 (1.1) |
0.1 (0.6) |
Rescue medication use, puffs/weeka |
|
1.2 (0.4) |
1.2 (0.4) |
Rescue-free days/weekb |
|
6.6 (1.4) |
6.6 (1.2) |
PEF >80%, days/weekb |
|
5.6 (1.9) |
5.5 (1.6) |
Controlled asthmab, n (%) |
|
203 (98.5) |
212 (98.1) |
Partly controlled asthmab, % |
|
2 (1.0) |
3 (1.4) |
Uncontrolled asthmab, % | 1 (0.5) | 1 (0.5) |
The values are means (SD). a the mean of the last 4 weeks of run-in period, b in each of the last 4 weeks of the run-in period. The lung function values were measured during the randomisation visit at the end of the run-in. BDP/F, beclomethasone dipropionate/formoterol; FP/S, fluticasone propionate/salmeterol; BMI, body mass index; FEV1, forced expiratory volume in 1 second; PEF, peak expiratory flow.