Demographic and baseline characteristics
| AICS-Bud 1 mg | AICS-Bud 0.5 mg | AICS-placebo | CN-Bud | All patients | |
| Patients n | 80 | 39 | 40 | 40 | 199 |
| Age years | 52.0±8.8 | 51.6±10.0 | 52.3±9.2 | 49.7±10.6 | 51.5±9.5 |
| Males | 24 (30.0) | 14 (35.9) | 16 (40.0) | 16 (40.0) | 70 (35.2) |
| Females | 56 (70.0) | 25 (64.1) | 24 (60.0) | 24 (60.0) | 129 (64.8) |
| BMI kg·m−2 | 28.2±5.5 | 28.7±5.4 | 27.8±5.4 | 27.7±3.8 | 28.1±5.2 |
| Duration of asthma years | 19.2±12.1 | 21.2±12.6 | 19.9±11.7 | 18.4±10.6 | 19.6±11.8 |
| MiniAQLQ total score | 3.6±0.9 | 3.7±1.0 | 3.7±0.7 | 3.6±1.0 | 3.6±0.9 |
| ACQ total score | 3.2±0.8 | 3.2±0.9 | 3.0±0.7 | 3.1±1.0 | 3.1±0.8 |
| FEV1 % predicted | 59.0±11.8 | 56.4±9.5 | 57.0±11.2 | 58.1±12.3 | 57.9±11.3 |
| Morning PEF L·min−1 | 253±100§ | 249±99ƒ | 269±101ƒ | 263±123ƒ | 257±104 |
| Evening PEF L·min−1 | 268±99§ | 268±98ƒ | 286±101ƒ | 272±124ƒ | 272±104 |
| FEF25–75% L·s−1 | 1.11±0.56## | 1.04±0.43¶¶ | 1.00±0.51ƒ | 1.11±0.61¶¶ | ND |
| OCS use# | |||||
| Baseline dose mg per day | 10.0±7.1 | 10.6±9.0 | 10.4±8.2 | 10.1±6.2 | 10.2±7.5 |
| Use of 5–10 mg per day | 63 (79) | 32 (82) | 31 (78) | 30 (75) | 156 (78) |
| SABA puffs per day | 4.6±3.7++ | 4.0±3.6§§ | 4.3±3.6ƒƒ | 4.3±3.1ƒ | 4.4±3.5### |
| Most common inhaled asthma medications¶ | |||||
| Salbutamol | 74 (92.5) | 36 (92.3) | 35 (87.5) | 37 (92.5) | 182 (91.5) |
| Fluticasone/salmeterol | 29 (36.3) | 12 (30.8) | 16 (40.0) | 17 (42.5) | 74 (37.2) |
| Formoterol | 20 (25.0) | 15 (38.5) | 9 (22.5) | 10 (25.0) | 54 (27.1) |
| Fluticasone | 18 (22.5) | 9 (23.1) | 13 (32.5) | 8 (20.0) | 48 (24.1) |
| Salmeterol | 18 (22.5) | 6 (15.4) | 10 (25.0) | 10 (25.0) | 44 (22.1) |
| Bud/formoterol fumarate | 13 (16.3) | 5 (12.8) | 4 (10.0) | 3 (7.5) | 25 (12.6) |
| Bud | 12 (15.0) | 4 (10.3) | 3 (7.5) | 6 (15.0) | 25 (12.6) |
| Beclometasone | 8 (10.0) | 8 (20.5) | 3 (7.5) | 2 (5.0) | 21 (10.6) |
| Fenoterol | 7 (8.8) | 5 (12.8) | 3 (7.5) | 3 (7.5) | 18 (9.0) |
| Tiotropium | 5 (6.3) | 6 (15.4) | 3 (7.5) | 2 (5.0) | 16 (8.0) |
| Ex-smokers+ | 7 (8.8) | 4 (10.3) | 3 (7.5) | 9 (22.5) | 23 (11.6) |
| Exposure pack-years | 5.3±3.0 | 5.5±2.6 | 8.0±1.0 | 5.2±3.1 | 5.7±2.8 |
Data are presented as mean±sd or n (%) unless otherwise stated. AICS: AKITA inhaled corticosteroid; Bud: budesonide; CN: conventional jet nebuliser; BMI: body mass index; AQLQ: Asthma Quality of Life Questionnaire; ACQ: Asthma Control Questionnaire; FEV1: forced expiratory volume in 1 s; PEF: peak expiratory flow; FEF25–75%: forced expiratory flow from 25% to 75% of vital capacity; OCS: oral corticosteroids; SABA: short-acting β2-agonists; ND: not determined. #: all patients were receiving OCS; prednisone was specified by the protocol for use during the study;¶: study eligibility specified that all patients were receiving long-acting β2-agonists; +: study eligibility specified patients were nonsmokers or ex-smokers; §: n=77; ƒ: n=38; ##: n=76; ¶¶: n=39; ++: n=75; §§: n=34; ƒƒ: n=37; ###: n=184.