|
Day relative to last dose
|
Time point
|
Adjusted Mean FEV1
|
Difference (FF/VI vs Placebo)
|
95% CI of the difference
|
|---|
|
n
|
FF/VI 100/25 mcg
|
n
|
Placebo
|
|---|
|
0
|
AM
|
27
|
0.44
|
27
|
0.18
|
0.26
|
(0.16, 0.36)
|
| |
PM
|
27
|
0.44
|
27
|
0.07
|
0.38
|
(0.28, 0.48)
|
|
1
|
AM
|
27
|
0.38
|
27
|
0.02
|
0.36
|
(0.26, 0.46)
|
| |
PM
|
27
|
0.41
|
27
|
0.15
|
0.26
|
(0.16, 0.36)
|
|
2
|
AM
|
27
|
0.37
|
27
|
0.03
|
0.34
|
(0.24, 0.44)
|
| |
PM
|
27
|
0.41
|
27
|
0.16
|
0.24
|
(0.14, 0.34)
|
|
3
|
AM
|
27
|
0.31
|
27
|
0.05
|
0.26
|
(0.16, 0.36)
|
| |
PM
|
27
|
0.36
|
27
|
0.18
|
0.18
|
(0.08, 0.28)
|
|
4
|
AM
|
27
|
0.29
|
27
|
0.05
|
0.24
|
(0.14, 0.34)
|
| |
PM
|
27
|
0.34
|
26
|
0.18
|
0.17
|
(0.07, 0.27)
|
|
5
|
AM
|
27
|
0.24
|
26
|
0.17
|
0.07
|
(−0.03, 0.17)
|
|
7a
|
AM
|
27
|
0.13
|
24
|
0.09
|
0.04
|
(−0.06, 0.14)
|
|
21a
|
AM
|
27
|
0.06
|
27
|
0.03
|
0.03
|
(−0.07, 0.13)
|
- Legend: Summary of repeated measures statistical analysis of change from baseline forced expiratory volume in one second (FEV1), in litres, after cessation of repeat dose of treatment. Day 1 to Day 5 data was collected whilst subjects were in-patients. aDay 7 and Day 21 measurements were taken during outpatient visits
