Background
Methods
Data sources and selection criteria
Data extraction
Baseline dyspnea index (BDI) and transition dyspnea index (TDI)
Statistical analyses
Results
Characteristics of included studies
Study | Design | Treatment arms | Number of patients | Treatment duration |
---|---|---|---|---|
Donohue [5] | Phase III, randomized, double-blind (indacaterol and placebo) or open-label (tiotropium), placebo-controlled, parallel-group, multicentre | Indacaterol 150 μg od | 1683 randomized; | 26 weeks |
Indacaterol 300 μg od | 1665 evaluable for efficacy | |||
Tiotropium 18 μg od | ||||
Placebo | ||||
Dahl [6] | Phase III, randomized, double-blind, double-dummy, placebo-controlled, parallel-group, multicentre | Indacaterol 300 μg od | 1732 randomized; | 52 weeks |
Indacaterol 600 μg od | 1600 evaluable for efficacy | |||
Formoterol 12 μg bid | ||||
Placebo | ||||
Kornmann [7] | Phase III, randomized, double-blind, double-dummy, placebo-controlled, parallel-group, multicentre | Indacaterol 150 μg od | 1002 randomized; | 26 weeks |
Salmeterol 50 μg bid | 998 evaluable for efficacy | |||
Placebo | ||||
Gotfried-1 [8] | Phase III, randomized, double-blind, placebo-controlled, parallel-group, in the United States | Indacaterol 75 μg od | 323 randomized; | 12 weeks |
Placebo | 323 evaluable for efficacy | |||
Gotfried-2 [8] | Phase III, randomized, double-blind, placebo-controlled, parallel-group, in the United States | Indacaterol 75 μg od | 318 randomized; | 12 weeks |
Placebo | 317 evaluable for efficacy | |||
Kinoshita [9] | Phase III, randomized, double-blind, placebo-controlled, parallel-group, in six Asian areas | Indacaterol 150 μg od | 347 randomized; | 12 weeks |
Indacaterol 300 μg od | 347 evaluable for efficacy | |||
Placebo |
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) |
Dyspnea – BDI and TDI
Study | Treatment arms | TDI at week 12 | ||
---|---|---|---|---|
Patients, na
| TDI total scoreb
| Number of patients with TDI ≥1 | ||
Donohue [5] | Indacaterol 150 μg od | 355 | 2.09 (-8, 9) | 209 |
Indacaterol 300 μg od | 363 | 2.40 (-9, 9) | 239 | |
Tiotropium 18 μg od | 360 | 1.89 (-6, 9) | 198 | |
Placebo | 326 | 1.19 (-6, 9) | 138 | |
Dahl [6] | Indacaterol 300 μg od | 364 | 2.11 (-9, 9) | 229 |
Indacaterol 600 μg od | 348 | 2.10 (-7, 9) | 202 | |
Formoterol 12 μg bid | 359 | 1.64 (-9, 9) | 190 | |
Placebo | 343 | 0.87 (-9, 9) | 138 | |
Kornmann [7] | Indacaterol 150 μg od | 303 | 2.37 (-6, 9) | 182 |
Salmeterol 50 μg bid | 296 | 1.60 (-6, 9) | 152 | |
Placebo | 286 | 0.87 (-9, 9) | 113 | |
Gotfried-1 [8] | Indacaterol 75 μg od | 150 | 1.36 (-6, 9) | 73 |
Placebo | 150 | 0.12 (-9, 9) | 48 | |
Gotfried-2 [8] | Indacaterol 75 μg od | 148 | 1.25 (-7, 9) | 69 |
Placebo | 149 | 0.83 (-6, 9) | 53 | |
Kinoshita [9] | Indacaterol 150 μg od | 108 | 2.16 (-3, 9) | 66 |
Indacaterol 300 μg od | 107 | 2.04 (-3, 9) | 58 | |
Placebo | 102 | 0.88 (-6, 9) | 40 |