| |
Study 1 INVOLVE [16]
|
Study 2 INHANCE [17]
|
Study 3 INLIGHT 1 [18]
|
Total
|
|---|
|
n
|
1377
|
1575
|
361
|
3313
|
|
Age, years
|
64 (8)
|
64 (9)
|
63 (10)
|
64 (9)
|
|
Male/female, %
|
78/22
|
63/37
|
52/48
|
69/31
|
|
Body mass index, kg/m2
|
27 (5)
|
27 (6)
|
28 (7)
|
27 (6)
|
|
FEV1, % predicted*
|
53 (14)
|
56 (14)
|
55 (14)
|
55 (14)
|
|
FEV1/FVC, %*
|
51 (10)
|
53 (10)
|
53 (10)
|
52 (10)
|
|
Pre-bronchodilator FEV1, l
|
1.35 (0.43)
|
1.33 (0.49)
|
1.34 (0.51)
|
1.34 (0.47)
|
|
Post-bronchodilator FEV1, l*
|
1.52 (0.47)
|
1.50 (0.50)
|
1.51 (0.52)
|
1.51 (0.49)
|
|
Reversibility, %*
|
13.2 (13.4)
|
15.5 (15.9)
|
16.0 (18.7)
|
14.6 (15.3)
|
|
ICS use yes/no, %
|
55/45
|
38/62
|
32/68
|
45/55
|
|
Smoker/ex-smoker, %
|
40/60
|
44/56
|
52/48
|
43/57
|
|
BDI score
|
6.6 (2.2)
|
6.5 (2.3)
|
NA
|
6.5 (2.2)
|
|
SGRQ total score
|
44 (18)
|
45 (18)
|
49 (19)
|
45 (18)
|
|
Treatments
| | | | |
|
Placebo, n
|
322
|
311
|
176
|
809
|
|
Indacaterol 75 μg, n
|
0
|
67
|
0
|
67
|
|
Indacaterol 150 μg, n
|
0
|
346
|
185
|
531
|
|
Indacaterol 300 μg, n
|
363
|
357
|
0
|
720
|
|
Indacaterol 600 μg, n
|
344
|
68
|
0
|
412
|
|
Formoterol 12 μg, n
|
348
|
75
|
0
|
423
|
|
Tiotropium 18 μg, n
|
0
|
351
|
0
|
351
|
- Data are mean (standard deviation) unless otherwise stated. *Measured 30 min after salbutamol 400 μg inhalation. Reversibility was calculated as the difference between the pre- and post-bronchodilator values of FEV1 (in l) as a percentage of the pre-bronchodilator value; BDI, Baseline Dyspnoea Index; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; ICS, inhaled corticosteroid; INVOLVE, INdacaterol: Value in COPD: Longer term Validation of Efficacy and safety; INHANCE, INdacaterol versus tiotropium to Help Achieve New COPD treatment Excellence; INLIGHT, INdacaterol: efficacy evaLuation usInG 150 μg doses with COPD PatienTs; NA, not available; SGRQ, St George's Respiratory Questionnaire.
