Table 1.
Baseline characteristics of study participants included in the analysis
| 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.