|
Average ΔFEV1 (ml)
|
Category midpoint value of ΔFEV1 (ml)
|
Withdrawal rate* (% patients)
|
TDI at 12 weeks (n = 2781)
|
TDI at 24/26 weeks (n = 2208)
|
TDI at 52 weeks (n = 1099)
|
ΔSGRQ at 12 weeks (n = 3141)
|
ΔSGRQ at 24/26 weeks (n = 2215)
|
ΔSGRQ at 52 weeks (n = 1115)
|
Rescue medication mean puffs per day (over study duration) (n = 3158)
|
Exacerbation rate (per year) (n = 3158)
|
Severe exacerbation rate (per year) (n = 3158)
|
|---|
|
-500, -50
|
-275
|
11.2
|
1.44
|
1.57
|
1.24
|
-3.15
|
-4.70
|
-2.21
|
2.46
|
0.63
|
0.059
|
|
-50, 50
|
0
|
9.0
|
1.31
|
1.39
|
1.92
|
-3.17
|
-3.81
|
-3.03
|
2.57
|
0.58
|
0.065
|
|
50, 150
|
100
|
10.1
|
1.79
|
1.97
|
1.65
|
-3.84
|
-4.74
|
-4.22
|
2.10
|
0.61
|
0.057
|
|
150, 250
|
200
|
10.2
|
2.12
|
2.23
|
2.23
|
-5.84
|
-6.34
|
-6.70
|
1.80
|
0.51
|
0.048
|
|
250, 500
|
375
|
6.7
|
2.68
|
3.03
|
3.27
|
-7.38
|
-7.29
|
-9.06
|
1.66
|
0.38
|
0.021
|
|
P value (Kruskal-Wallis)
| | |
< 0.001
|
< 0.001
|
< 0.001
|
< 0.001
|
< 0.001
|
< 0.001
|
< 0.001
|
< 0.001
|
0.1
|
|
Correlation, individual level
| | |
0.15
|
0.14
|
0.18
|
-0.12
|
-0.07
|
-0.16
|
-0.11
|
-0.06
|
-0.03
|
|
Correlation, cohort level
| | |
0.90
|
0.88
|
0.92
|
-0.90
|
-0.79
|
-0.95
|
-0.88
|
-0.89
|
-0.81
|
- *Non-completers in all studies categorised by ΔFEV1 at Day 2; ΔFEV1, change from baseline in trough forced expiratory volume in 1 second; TDI, Transition Dyspnoea Index; ΔSGRQ, change from baseline in St George's Respiratory Questionnaire
