Budesonide/Formoterol Maintenance and Reliever Therapy Result in Similar or Better Asthma Control Compared With Conventional Treatment: Presented at ERS

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Title: Budesonide/Formoterol Maintenance and Reliever Therapy Result in Similar or Better Asthma Control Compared With Conventional Treatment: Presented at ERS
URL: http://www.pslgroup.com/dg/22E786.htm
Doctor's Guide
October 9, 2008

By Chris Berrie

BERLIN -- October 9, 2008 -- The combination of budesonide and formoterol for maintenance and reliever therapy for patients with asthma provides similar or better asthma control compared with conventional best standard treatment, with significantly reduced inhaled corticosteroid (ICS), according to a multicentre, randomised, open-label, parallel-group study.

Coinvestigator Nanna Dam, MPharm, Medical Affairs, AstraZeneca A/S, Albertslund, Denmark, presented the study results here on October 7 at the European Respiratory Society (ERS) 18th Annual Congress.

Recent trials confirmed the benefits of combined maintenance plus reliever therapy with budesonide and formoterol. Therefore, Dam and colleagues evaluated the efficacy and safety of combination maintenance and reliever therapy with budesonide and formoterol versus conventional best standard treatment in patients with persistent asthma in a real-life clinical setting.

To maintain the real-life setting over the 6 months of the study, few clinic visits were scheduled and medications were dispensed by local pharmacies free of charge to patients.

The study enrolled 1,835 patients in Denmark, Finland, and Norway, who were 12 years or older with a 3-month or greater documented history of asthma, and a prescribed ICS dose of 320 mcg or more. At inclusion, patients were using an ICS plus a long-acting beta-agonist treatment or used an ICS alone with a history of being symptomatic with suboptimal asthma control.

Study treatment consisted of fixed-dose budesonide/formoterol 160/4.5 mg twice daily and no other treatment was allowed. Budesonide/formoterol 160/4.5 mg was also allowed on an as-needed basis for asthma exacerbations. The standard-treatment group was treated according to Global Initiative for Asthma (GINA) guidelines, with their asthma medication adjusted or changed at any time during the study at the discretion of their treating physician.

The primary outcome variable was time to first severe exacerbation, defined as deterioration in asthma resulting in hospitalisation or emergency treatment, or the need for oral steroids for 3 or more days. Secondary outcome variables included number of exacerbations, asthma control using the 5-item Asthma Control Questionnaire (ACQ), and medication use.

A total of 914 patients were randomised to conventional best standard treatment and 921 to budesonide/formoterol. Mean ages of patients in the 2 groups were 42 and 43 years (male, 41% and 39%), respectively.

At study entry, the medications used in the 2 groups were similar (1,051 and 1,018 mcg/day ICS, respectively) and 75.6% and 74.4%, respectively, used a long-acting beta-agonist.

No significant difference was seen between treatment groups for the primary outcome, although there was a trend towards benefit with budesonide/formoterol (hazard ratio, 0.79; P = .189). Similarly, there was a trend towards a significant difference in the number of exacerbations per patient for budesonide/formoterol (rate ratio, 0.74; P = .058).

According to ACQ scores, significantly more patients were well controlled (ACQ <0.75) with budesonide/formoterol compared with standard treatment at the end of the study (P < .01).

For asthma medication use, Dam stressed, "All of these results were based on a lower inhaled corticosteroid dose, at about 30% less." This difference was significant (753 vs 1,092 mcg/day; P < .0001), although the number of as-needed reliever inhalations was similar across the 2 treatment groups.

No safety concerns were apparent, with similar numbers of serious adverse events in the 2 treatment groups. However, more patients in the budesonide/formoterol group discontinued the trial due to adverse events.

Funding for this study was provided by AstraZeneca.

[Presentation title: Budesonide/Formoterol Maintenance and Reliever Therapy Compared With Conventional Best Standard Treatment. Abstract P3508]

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