Table 2.
Patient characteristics at baseline in the individual studies
| Study | Treatment arms | Patients, na | Age, years | Male, n (%) | Smoking history, pack-years | FEV1, Lb | FEV1, % predb | FEV1/FVC, %b | BDI total scorec |
|---|---|---|---|---|---|---|---|---|---|
| Donohue [5] |
Indacaterol 150 μg od |
416 |
63.4 (40, 87) |
259 (62.3) |
48.3 (20, 150) |
1.52 (0.62, 3.45) |
56.1( 29.3, 116.6) |
53.0 (24.4, 69.7) |
6.56 (0, 12) |
| Indacaterol 300 μg od |
416 |
63.3 (40, 88) |
263 (63.2) |
50.8 (13, 208) |
1.53 (0.57, 3.14) |
56.3 (21.3, 90.0) |
52.6 (25.7, 69.5) |
6.52 (0, 12) |
|
| Tiotropium 18 μg od |
415 |
64.0 (41, 85) |
269 (64.8) |
50.0 (20, 180) |
1.45 (0.48, 3.00) |
53.9 (23.6, 132.3) |
52.7 (24.7, 72.6) |
6.57 (0, 12) |
|
| Placebo |
418 |
63.6 (41, 84) |
255 (61.0) |
49.7 (20, 156) |
1.51 (0.53, 2.98) |
56.1 (28.4, 95.1) |
53.4 (24.0, 69.9) |
6.39 (0, 12) |
|
| Dahl [6] |
Indacaterol 300 μg od |
437 |
63.9 (40, 87) |
351 (80.3) |
48.6 (20, 600) |
1.48 (0.44, 2.95) |
52.8 (23.5, 101.4) |
51.1 (27.7, 90.1) |
6.62 (0, 12) |
| Indacaterol 600 μg od |
425 |
62.9 (40, 87) |
327 (76.9) |
53.6 (20, 900) |
1.48 (0.55, 2.91) |
51.6 (24.0, 84.2) |
51.1 (15.8, 84.4) |
6.57 (0, 12) |
|
| Formoterol 12 μg bid |
434 |
63.6 (40, 84) |
348 (80.2) |
49.0 (20, 800) |
1.50 (0.59, 3.25) |
52.9 (20.8, 100.5) |
51.3 (23.0, 96.5) |
6.46 (1, 12) |
|
| Placebo |
432 |
63.2 (41, 90) |
352 (81.5) |
53.3 (20, 900) |
1.52 (0.58, 3.09) |
52.9 (17.6, 96.3) |
52.1 (21.5, 80.0) |
6.52 (0, 12) |
|
| Kornmann [7] |
Indacaterol 150 μg od |
330 |
63.2 (41, 85) |
238 (72.1) |
39.6 (20, 120) |
1.48 (0.63, 2.93) |
53.9 (30.0, 104.4) |
53.5 (23.5, 76.8) |
6.74 (0, 12) |
| Salmeterol 50 μg bid |
333 |
63.4 (41, 86) |
249 (74.8) |
40.0 (20, 147) |
1.48 (0.43, 3.18) |
53.1 (17.9, 93.4) |
52.2 (18.0, 82.2) |
6.68 (0, 12) |
|
| Placebo |
335 |
63.9 (42, 89) |
258 (77.0) |
41.0 (20, 159) |
1.46 (0.47, 3.20) |
53.0 (12.3, 91.0) |
52.7 (20.2, 90.9) |
6.63 (0, 12) |
|
| Gotfried-1 [8] |
Indacaterol 75 μg od |
163 |
64.0 (44, 85) |
89 (54.6) |
52.9 (10, 150) |
1.49 (0.57, 2.92) |
53.7 (30.3, 77.3) |
53.1 (31.8, 68.3) |
6.40 (2, 12) |
| Placebo |
160 |
64.1 (40, 90) |
87 (54.4) |
51.2 (10, 148) |
1.46 (0.62, 2.77) |
53.3 (29.5, 78.7) |
51.6 (25.6, 69.1) |
5.81 (1, 12) |
|
| Gotfried-2 [8] |
Indacaterol 75μg od |
159 |
61.3 (40, 82) |
83 (52.2) |
52.4 (11, 180) |
1.59 (0.65, 3.39) |
55.7 (29.7, 79.3) |
52.4 (22.9, 68.6) |
6.01 (0, 12) |
| Placebo |
158 |
61.5 (42, 86) |
89 (56.0) |
52.4 (10, 204) |
1.52 (0.56, 3.00) |
53.5 (30.3, 79.4) |
52.6 (28.8, 69.1) |
6.15 (1, 11) |
|
| Kinoshita [9] |
Indacaterol 150 μg od |
114 |
66.4 (46, 83) |
110 (96.5) |
51.7 (20, 196) |
1.46 (0.70, 2.50) |
55.2 (30.0, 79.0) |
50.3 (27.0, 69.0) |
7.53 (1, 12) |
| Indacaterol 300 μg od |
116 |
67.1 (48, 86) |
113 (97.4) |
54.0 (20, 150) |
1.41 (0.68, 2.92) |
53.7 (30.0, 79.0) |
48.7 (27.0, 69.0) |
7.67 (1, 12) |
|
| Placebo | 117 | 66.5 (40, 88) | 112 (95.7) | 49.7 (20, 160) | 1.38 (0.55, 2.37) | 52.3 (30.0, 77.0) | 47.7 (28.0, 69.0) | 7.35 (1, 12) |
Data are mean (min, max) for age, smoking history, FEV1, FEV1 % predicted, and FEV1/FVC% unless stated otherwise.
a Number of patients analysed for efficacy (ITT, modified ITT or FAS).
b Post-bronchodilator spirometry.
c Values for patients who provided data at Week 12.