title: Nebulised budesonide using a novel device in patients with oral steroid-dependent asthma.
abstract: This phase 2/3 randomised, parallel-group, placebo-controlled trial investigated oral corticosteroid (OCS)-sparing efficacy, safety and tolerability of nebulised budesonide (Bud) administered with a novel computer-controlled, compressor-driven inhalation system (AKITA) as add-on therapy to Global Initiative for Asthma step 5. Patients (18-65 years) with OCS-dependent asthma were randomised (2:1:1:1) to receive 18-week, twice-daily, double-blind treatment with AKITA inhaled corticosteroid (AICS)-Bud 1 mg, AICS-Bud 0.5 mg, AICS-placebo or open-label Bud 1 mg administered by conventional nebuliser (CN-Bud). OCS doses were tapered until week 14. 199 patients started treatment. More AICS-Bud 1 mg (80.0%) than placebo-treated (62.5%) patients had daily OCS doses reduced ≥50%, with clinical stability to week 18 (one-sided p=0.02; treatment difference: 17.5% (95% CI 0.1-34.9%), two-sided p=0.04). Mean±sd forced expiratory volume in 1 s improved (from baseline to week 18) for AICS-Bud 1 mg (239±460 mL, p<0.001) and AICS-Bud 0.5 mg (126±345 mL, p=0.01) but not placebo (93±419 mL, p=0.36) or CN-Bud (137±459 mL, p=0.18). Fewer AICS-Bud 1 mg-treated patients experienced asthma exacerbations (7.5%) compared with placebo (17.5%) or CN-Bud (22.5%). All treatments were well tolerated. Budesonide applied with AKITA allowed significant meaningful OCS reduction in OCS-dependent asthma patients while improving pulmonary function and maintaining exacerbation control.
authors.affiliation: Dept of Medicine, Pulmonary and Critical Care Medicine, German Center for Lung Research (DZL), University Medical Center Giessen and Marburg, Philipps-University Marburg, Marburg, Germany.
authors.forename: Claus
authors.initials: C
authors.lastname: Vogelmeier
authors.affiliation: Respiratory Group Practice at Red Cross Maingau Hospital, Frankfurt, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Kardos
authors.affiliation: Vectura GmbH, Gemuenden, Germany Vectura GmbH, Gemuenden, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Hofmann
authors.affiliation: Vectura GmbH, Gemuenden, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Canisius
authors.affiliation: Vectura GmbH, Gemuenden, Germany.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Scheuch
authors.affiliation: Vectura GmbH, Gemuenden, Germany.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Muellinger
authors.affiliation: Vectura GmbH, Gemuenden, Germany.
authors.forename: Karlheinz
authors.initials: K
authors.lastname: Nocker
authors.affiliation: Aumapharma Inc., Doylestown, PA, USA.
authors.forename: Guenter
authors.initials: G
authors.lastname: Menz
authors.affiliation: Aumapharma Inc., Doylestown, PA, USA k.f.rabe@lungenclinic.de.
authors.forename: Klaus F
authors.initials: KF
authors.lastname: Rabe
mesh_terms: D000280:Administration, Inhalation; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage; D019819:Budesonide / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D016503:Drug Delivery Systems / Q000295:instrumentation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D061214:Patient Safety; D011241:Prednisone / Q000008:administration & dosage; D013256:Steroids / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018927:Anti-Asthmatic Agents; D001993:Bronchodilator Agents; D013256:Steroids; D019819:Budesonide; D011241:Prednisone