Efficacy results
| AICS-Bud 1 mg | AICS-Bud 0.5 mg | AICS-Placebo | CN-Bud 1 mg | |
| Patients n | 80 | 31 | 25 | 30 |
| Primary end-point | ||||
| Reduction of OCS ≥50% from baseline with clinical stability to 18 weeks# | 64 (80.0)* | 31 (79.5) | 25 (62.5) | 30 (75.0) |
| Secondary end-points | ||||
| OCS | ||||
| Fully weaned off OCS at 18 weeks | 45 (56.3) | 20 (51.3) | 17 (42.5) | 18 (45.0) |
| Reduction of daily OCS from baseline to 18 weeks % | 74.8±48.9* (n=77) | 77.5±31.6 (n=38) | 51.7±62.9 (n=40) | 70.6±59.6 (n=39) |
| Absolute reduction of daily OCS from baseline to 18 weeks mg | 7.1±6.0** (n=77) | 7.6±6.2 (n=38) | 3.6±6.7 (n=40) | 6.8±5.7 (n=39) |
| Lung function | ||||
| Change in FEV1 from baseline to 18 weeks % | 16.5±30.3 (n=76) | 9.5±20.7 (n=39) | 6.2±24.6 (n=39) | 8.6±27.8 (n=39) |
| Absolute change in FEV1 from baseline to 18 weeks % pred | 8.8±16.7 (n=76) | 5.4±11.5 (n=39) | 3.0±13.5 (n=39) | 4.0±14.3 (n=39) |
| Absolute change in morning PEF from baseline to 18 weeks L·min−1 | 25.3±65.6 (n=74) | 17.8±39.0 (n=38) | 14.9±47.6 (n=37) | 28.2±56.7 (n=37) |
| Absolute change in evening PEF from baseline to 18 weeks L·min−1 | 22.6±60.4 (n=74) | 12.1±44.6 (n=37) | 7.8±56.9 (n=37) | 31.0±57.8 (n=37) |
| Absolute change in FEF25–75% from baseline to 18 weeks¶ L·min−1 | +0.20±0.60* (n=76) | +0.08±0.44 (n=39) | 0.00±0.40 (n=38) | +0.05±0.71 (n=39) |
| Exacerbations and instability | ||||
| ≥1 asthma exacerbation | 6 (7.5) | 3 (7.7) | 7 (17.5) | 9 (22.5) |
| Time to first asthma exacerbation days | 96.5±51.2 (n=6) | 87.7±47.0 (n=3) | 47.9±34.7 (n=7) | 50.1±35.3 (n=9) |
| ≥1 severe asthma exacerbation | 1 (1.3) | 1 (2.6) | 3 (7.5) | 1 (2.5) |
| Asthma instability+ | 12 (15.0) | 5 (12.8) | 12 (30.0) | 10 (25.0) |
| Absolute change in SABA dose from baseline to 18 weeks puffs per day | −1.5±2.5** (n=70) | −1.4±2.5 (n=37) | −0.4±1.8 (n=33) | −1.6±2.9 (n=35) |
| Bud-equivalent inhaled corticosteroid dose§ µg per day | 1349.6±1189.3 | 1253.8±743.5 | 1627.0±872.0 | 1329.3±717.5 |
| Patients hospitalised for asthma | 1 (1.3)* | 1 (2.6) | 4++ (10) | 1 (2.5) |
| Total time hospitalised/total study durationƒ days | 5/13 152*** | 5/6568 | 49/6328 | 5/6660 |
| ACQ question 1: nocturnal awakenings## | ||||
| Improvement | 46 (57.5) | 21 (53.8) | 17 (42.5) | 23 (57.5) |
| No change | 19 (23.8) | 15 (38.5) | 14 (35.0) | 12 (30.0) |
| Deterioration | 11 (13.8) | 3 (7.7) | 7 (17.5) | 4 (10.0) |
| No data | 4 (5.0) | 0 (0) | 2 (5.0) | 1 (2.5) |
| Quality of life | ||||
| Change in MiniAQLQ score from baseline to 18 weeks¶¶ | 0.83±1.16* (n=73) | 0.82±0.98 (n=36) | 0.37±0.87 (n=38) | 0.84±1.21 (n=36) |
Data are presented as n (%) unless otherwise stated. AICS: AKITA inhaled corticosteroid; Bud: budesonide; CN: conventional jet nebuliser; OCS: oral corticosteroids; FEV1: forced expiratory volume in 1 s; PEF: peak expiratory flow; FEF25–75%: forced expiratory flow from 25% to 75% of vital capacity; SABA: short-acting β2-agonists; ACQ: Asthma Control Questionnaire; AQLQ: Asthma Quality of Life Questionnaire. #: patients with severe exacerbations (requiring hospitalisation/emergency intervention) and mild–moderate exacerbations requiring OCS increases of more than two reverse-tapering steps were considered not to have reached the primary end-point.¶: exploratory analysis; missing data imputed using last observation carried forward; compared with Wilcoxon–Mann–Whitney test.+: increase in OCS dose required; increases were made according to the stability criteria and using the reverse of the OCS-tapering steps.§: calculated using the inhaled corticosteroid conversion tables found in the British Guideline on the Management of Asthma [25]; concomitant use of inhaled corticosteroid is presented; use remained unchanged during the study.ƒ: compared with Fisher's exact probability.##: improvement or deterioration defined as change of ≥1 point from baseline to week 18.¶¶: minimal clinically important difference, 0.5 points.++: one patient also had pseudomonal lung infection. *: p<0.05 comparing AICS-Bud 1 mg with AICS-placebo; **: p<0.01 comparing AICS-Bud 1 mg with AICS-placebo; ***p<0.001 comparing AICS-Bud 1 mg with AICS-placebo.