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Int J Clin Pract. 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.

Author information

1
Pneumology, CHU Sart Tilman, Liège, Belgium. r.louis@chu.ulg.ac.be

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.

PMID:
19769705
PMCID:
PMC2780558
DOI:
10.1111/j.1742-1241.2009.02185.x
[Indexed for MEDLINE]
Free PMC Article

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