A Comparison of Budesonide/Formoterol Maintenance and Reliever Therapy Versus Conventional Best Practice in Asthma Management in Spain

Abstract

Objective. To study the effectiveness and safety in a real-life setting of budesonide/formoterol (Symbicort) Maintenance And Reliever Therapy® (Symbicort SMART®), a simplified management approach with one inhaler, compared with conventional best practice (CBP) with multiple inhalers in patients with persistent asthma. Design. Open-label randomized controlled parallel-group trial, 6-month treatment. Participants. A total of 654 adult patients, with persistent asthma receiving treatment with inhaled corticosteroids (ICS), either alone or in conjunction with long-acting β₂-agonist. Main outcome measures. Time to first severe asthma exacerbation and number of severe asthma exacerbations. Results. No difference between groups was seen in time to first severe exacerbation (p = .2974). Exacerbation rates were low in both groups. A total of 22 patients in the Symbicort SMART group experienced a total of 24 severe asthma exacerbations, and 31 patients in the CBP group experienced a total of 34 severe asthma exacerbations (annual rate 0.16 vs. 0.22, p = .2869). The mean daily dose of ICS expressed in beclomethasone dipropionate equivalent was significantly lower in the Symbicort SMART group (including as-needed use) versus the CBP group (799 μg vs.1184 μg; p < .001). Mean scores in Asthma Control Questionnaire, five-question version, improved significantly in the SMART group compared with the CBP group (p = .0292). Symbicort SMART and CBP were equally well tolerated. The mean drug cost per patient per 6 months was lower for the patients in the SMART group compared with patients receiving CBP (€295.32 vs. €387.98, p < .0001). Conclusions. A simplified regimen using budesonide/formoterol maintenance and reliever therapy (Symbicort SMART) was at least as effective at improving clinical control compared with CBP with a significantly lower ICS dose and lower drug costs.

• cost analysis
• asthma exacerbations
• asthma treatment
• budesonide/formoterol

Acknowledgements

S. Quirce has been on advisory boards and has received speaker’s honoraria from AstraZeneca, GlaxoSmithKline, MSD, Novartis, Almirall, Altana, Chiesi, and Pfizer. V. Plaza has received speaker’s honoraria from AstraZeneca, GlaxoSmithKline, MSD, Novartis, Almirall, and Chiesi. E. Calvo has participated in advisory committees for GlaxoSmithKline, Nycomed, and Novartis. He has coordinated international clinical trials in primary care sponsored by AstraZeneca and has received speaker’s honoraria from Boehringher, Pfizer, AstraZeneca, GlaxoSmithKline, Chiesi, MSD, and Almirall. Ruben Ampudia was full-time employee of Quintiles Iberia SAU at the time of the study. C. Barcina, M. Muñoz, and M. Capel were full-time employees of AstraZeneca Farmacéutica Spain S.A. at the time of the study.

Declaration of Interests

The authors report no conflicts of interest. The authors alone are responsible for the writing and content of this paper.