Get access

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

Authors


  • Conflict of Interest Statement: AstraZeneca contributed to the funding, design, analysis and writing of the study. T. Atienza and WB have been members of scientific advisory boards and received honoraria for lectures and research grants from GlaxoSmithKline, AstraZeneca, Abott and Novartis. TK is employed by AstraZeneca KK in Japan, and JE, SI and LGC are employed by AstraZeneca R&D in Sweden.

Correspondence: Tito Atienza, Mary Mediatrix Medical Center, JP Laurel Highway, Lipa City, Batangas 4217, Philippines. Email: drtito104@yahoo.com

Abstract

Background and objective

To evaluate the efficacy and tolerability of budesonide/formoterol as maintenance and reliever therapy versus budesonide/formoterol maintenance plus terbutaline in adults with persistent asthma not adequately controlled with inhaled corticosteroid (ICS) therapy alone.

Methods

In this 12-month, randomized, double-blind, parallel-group, phase III study (NCT00839800), patients (age ≥16 years; receiving maintenance ICS; ≥1 severe exacerbation in the 12 months prior to study entry) were randomized to either budesonide/formoterol 160/4.5 μg 1 inhalation twice daily plus budesonide/formoterol 160/4.5 μg as-needed or budesonide/formoterol 160/4.5 μg 1 inhalation twice daily plus terbutaline 0.4 mg as-needed for 12 months. Primary outcome: time to first severe asthma exacerbation; secondary outcomes included: lung function, asthma symptom variables and tolerability.

Results

Two thousand and ninety-one patients were randomized: 170 (16%) receiving budesonide/formoterol maintenance and reliever therapy experienced 259 severe exacerbations versus 229 patients (22%) receiving budesonide/formoterol plus terbutaline who experienced 363 severe exacerbations. Budesonide/formoterol maintenance and reliever therapy prolonged the time to first severe exacerbation versus budesonide/formoterol plus terbutaline (P = 0.0007) and reduced the instantaneous risk of an exacerbation by 30% (hazard ratio 0.70, 95% confidence interval 0.57–0.85, P = 0.0003). Times to first oral steroid use, first hospitalization and first emergency room treatment were all significantly prolonged in the budesonide/formoterol maintenance and reliever group versus budesonide/formoterol plus terbutaline. Both treatment groups were well tolerated.

Conclusions

Budesonide/formoterol maintenance and reliever therapy provided more effective asthma control, including a prolonged time to first severe asthma exacerbation, than budesonide/formoterol plus terbutaline and was well tolerated. Budesonide/formoterol maintenance and reliever therapy also improved lung function and asthma symptoms.

Ancillary