Budesonide/formoterol maintenance and reliever therapy via Turbuhaler versus fixed‐dose budesonide/formoterol plus terbutaline in patients with asthma: Phase III study results

摘要: Background and objective To evaluate the efficacy tolerability of budesonide/formoterol as maintenance reliever therapy versus plus terbutaline in adults with persistent asthma not adequately controlled inhaled corticosteroid (ICS) alone. Methods In this 12-month, randomized, double-blind, parallel-group, phase III study (NCT00839800), patients (age ≥16 years; receiving ICS; ≥1 severe exacerbation 12 months prior to entry) were randomized either 160/4.5 μg 1 inhalation twice daily as-needed or 0.4 mg for months. Primary outcome: time first exacerbation; secondary outcomes included: lung function, symptom variables tolerability. Results Two thousand ninety-one randomized: 170 (16%) experienced 259 exacerbations 229 (22%) who 363 exacerbations. Budesonide/formoterol prolonged (P = 0.0007) reduced instantaneous risk an by 30% (hazard ratio 0.70, 95% confidence interval 0.57–0.85, P = 0.0003). Times oral steroid use, hospitalization emergency room treatment all significantly group terbutaline. Both groups well tolerated. Conclusions Budesonide/formoterol provided more effective control, including a exacerbation, than was tolerated. also improved function symptoms.