Efficacy results

AICS-Bud 1 mgAICS-Bud 0.5 mgAICS-PlaceboCN-Bud 1 mg
Patients n80312530
Primary end-point
Reduction of OCS ≥50% from baseline with clinical   stability to 18weeks#64 (80.0)*31 (79.5)25 (62.5)30 (75.0)
Secondary end-points
  Fully weaned off OCS at 18weeks45 (56.3)20 (51.3)17 (42.5)18 (45.0)
  Reduction of daily OCS from baseline to 18weeks %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    18weeks mg7.1±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 18weeks %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    18weeks % pred8.8±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    18weeks L·min−125.3±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    18weeks L·min−122.6±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    18weeks 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 exacerbation6 (7.5)3 (7.7)7 (17.5)9 (22.5)
  Time to first asthma exacerbation days96.5±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 exacerbation1 (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    18weeks 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 day1349.6±1189.31253.8±743.51627.0±872.01329.3±717.5
  Patients hospitalised for asthma1 (1.3)*1 (2.6)4++ (10)1 (2.5)
  Total time hospitalised/total study durationƒ days5/13 152***5/656849/63285/6660
  ACQ question 1: nocturnal awakenings##
   Improvement46 (57.5)21 (53.8)17 (42.5)23 (57.5)
   No change19 (23.8)15 (38.5)14 (35.0)12 (30.0)
   Deterioration11 (13.8)3 (7.7)7 (17.5)4 (10.0)
   No data4 (5.0)0 (0)2 (5.0)1 (2.5)
 Quality of life
  Change in MiniAQLQ score from baseline to 18weeks¶¶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.