Baseline demographics and clinical characteristics (randomised set)
| IND/GLY/MF medium-dose N=52 | IND/GLY/MF high-dose N=52 | IND/MF medium-dose N=51 | IND/MF high-dose N=51 | SAL/FLU high-dose N=52 | Total N=258 | |
| Age, years | 52.4±11.57 | 49.4±11.72 | 50.9±12.50 | 52.4±10.52 | 51.9±12.30 | 51.4±11.71 |
| Women, n (%) | 28 (53.8) | 37 (71.2) | 37 (72.5) | 34 (66.7) | 36 (69.2) | 172 (66.7) |
| Number of asthma exacerbations that required treatment in the 12 months prior to start of study, n (%) | ||||||
| 1 | 39 (75.0) | 41 (78.8) | 34 (66.7) | 31 (60.8) | 41 (78.8) | 186 (72.1) |
| 2 | 10 (19.2) | 10 (19.2) | 16 (31.4) | 12 (23.5) | 8 (15.4) | 56 (21.7) |
| 3 | 3 (5.8) | 0 | 0 | 3 (5.9) | 0 | 6 (2.3) |
| ≥4 | 0 | 1 (1.9) | 1 (2.0) | 5 (9.8) | 3 (5.8) | 10 (3.9) |
| Never smoked, n (%) | 44 (84.6) | 48 (92.3) | 47 (92.2) | 45 (88.2) | 45 (86.5) | 229 (88.8) |
| Baseline ACQ-7 score* | 2.2±0.46 | 2.3±0.67 | 2.3±0.45 | 2.4±0.52 | 2.3±0.40 | 2.3±0.51 |
| Pre-bronchodilator FEV1, % predicted | 55.6±14.80 | 57.1±13.65 | 56.4±11.50 | 53.6±14.33 | 54.3±13.59 | 55.4±13.58 |
| FEV1 reversibility after salbutamol inhalation, % increase† | 26.0±15.13 | 28.2±12.23 | 27.0±13.26 | 29.2±13.59 | 26.7±13.44 | 27.4±13.50 |
| Prior asthma treatment, n (%) | ||||||
| LABA/ICS medium-dose | 32 (61.5) | 32 (61.5) | 35 (68.6) | 36 (70.6) | 29 (55.8) | 164 (63.6) |
| LABA/ICS high-dose | 19 (36.5) | 19 (36.5) | 15 (29.4) | 15 (29.4) | 23 (44.2) | 91 (35.3) |
IND/GLY/MF medium-dose, IND/GLY/MF 150/50/80 µg one time per day; IND/GLY/MF high-dose, IND/GLY/MF 150/50/160 µg one time per day; IND/MF medium-dose, IND/MF 150/160 µg one time per day; IND/MF high-dose, IND/MF 150/320 µg one time per day; SAL/FLU high-dose, SAL/FLU 50/500 µg two times per day. Data presented as mean±SD, unless otherwise specified.
*The baseline ACQ-7 score was reported at screening, or if missing, at the last visit from run-in.
†FEV1 reversibility was calculated as increase of FEV1 value after inhalation of bronchodilator (400 µg salbutamol/360 µg albuterol, or equivalent dose) relative to FEV1 value before inhalation of bronchodilator.
ACQ, Asthma Control Questionnaire; eCRF, electronic case report form; FEV1, forced expiratory volume in 1 s; IND/GLY/MF, indacaterol acetate/glycopyrronium bromide/mometasone furoate; IND/MF, indacaterol acetate/mometasone furoate; LABA/ICS, long-acting β2-agonist/inhaled corticosteroid; SAL/FLU, salmeterol xinafoate/fluticasone propionate.