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Randomized Controlled Trial
. 2009 Oct;63(10):1479-88.
doi: 10.1111/j.1742-1241.2009.02185.x.

A comparison of budesonide/formoterol maintenance and reliever therapy vs. conventional best practice in asthma management

R Louis  1 , G Joos, A Michils, G Vandenhoven
Affiliations
Free PMC article
Randomized Controlled Trial

A comparison of budesonide/formoterol maintenance and reliever therapy vs. conventional best practice in asthma management

R Louis et al. Int J Clin Pract. 2009 Oct.
Free PMC article

Abstract

Objective: To study the effectiveness and safety of budesonide/formoterol (Symbicort) Maintenance And Reliever Therapy (Symbicort SMART, AstraZeneca, Södertalje, Sweden), a simplified management approach with one inhaler compared with conventional best practice (CBP) with multiple inhalers in patients with persistent asthma.

Design: Open-label randomised controlled parallel group trial, 6-month treatment.

Participants: A total of 908 patients > or = 12 years of age, with persistent asthma receiving treatment with inhaled corticosteroids (ICS), either alone or in conjunction with long-acting beta(2)-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 = 0.75). Exacerbation rates were low in both groups. A total of 12 patients in the Symbicort SMART group experienced a total of 14 severe asthma exacerbations, and 19 patients in the CBP group experienced a total of 25 severe asthma exacerbations (annual rate 0.07 vs. 0.13 p = 0.09). The mean daily dose of ICS expressed in BDP equivalent was significantly lower in the Symbicort SMART group (including as-needed use) vs. in the CBP group (749 microg vs. 1059 microg; p < 0.0001). Mean scores in Asthma Control Questionnaire, 5 question version improved significantly in the SMART group compared with the CBP group (p = 0.0026). Symbicort SMART and CBP were equally well tolerated. The mean drug cost/patient/month was significantly lower for the patients in the Symbicort SMART group compared with patients receiving CBP (51.3 euros vs. 66.5 euros; p < 0.0001).

Conclusions: In Belgian patients, a simplified regimen using budesonide/formoterol maintenance and reliever therapy was at least as effective at improving clinical control compared with CBP with a significantly lower ICS dose and significantly lower drug costs.

Trial registration: ClinicalTrials.gov NCT00290264.

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Figures

Figure 1
Figure 1
Trial profile
Figure 2
Figure 2
(A) Kaplan–Meier plot of time to first severe asthma exacerbation. (B) Asthma control over time assessed by Questionnaire (ACQ5). SMART = SMART; CBP = conventional best practice according to Global Initiative for Asthma (GINA) treatment guidelines
See this image and copyright information in PMC

References

    1. Global Initiative for Asthma. National Heart and Lung Institute, National Institutes of Health USA, and the world health Organization. http://www.ginasthma.org (accessed November 2006)
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    1. Pauwels RA, Lofdahl CG, Postma DS, et al. Effect of inhaled formoterol and budesonide on exacerbations of asthma. Formoterol and Corticosteroids Establishing Therapy (FACET) International Study Group. N Engl J Med. 1997;337:1405–11. - PubMed
    1. Zetterstrom O, Buhl R, Mellem H, et al. Improved asthma control with budesonide/formoterol in a single inhaler, compared with budesonide alone. Eur Respir J. 2001;18:262–8. - PubMed

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