Budesonide plus formoterol associated with better control of persistent asthma control than gold standard therapy

August 1, 2007

In a 6-month, randomized, double-blind study, use of budesonide/formoterol as both maintenance and reliever therapy was demonstrated to provide better asthma control than either salmeterol/fluticasone plus terbutaline as needed or a fixed maintenance dose of budesonide/formoterol plus terbutaline as needed.

Key Points

In a 6-month, randomized, double-blind study published in the International Journal of Clinical Practice, the use of budesonide/formoterol as both maintenance and reliever therapy was demonstrated to provide better asthma control than either salmeterol/fluticasone plus terbutaline as needed or a fixed maintenance dose of budesonide/formoterol plus terbutaline as needed.

Current National Heart Lung and Blood (NHLBI) treatment guidelines recommend that patients with persistent asthma be treated with a fixed-dose inhaled corticosteroid (ICS) or an inhaled corticosteroid/long-acting beta2-agonist combination administered twice daily plus a short-acting beta2-agonist as needed for symptom relief. However, the authors of the current study stated that such treatment provides suboptimal asthma control.

This study included 3,335 patients aged ≥12 years who were diagnosed with asthma (using American Thoracic Society criteria) ≥6 months before the start of the study and who were using ICSs for ≥3 months. Patients were randomized to 1 of 3 treatment strategies: 1) budesonide/formoterol 160/4.5 mcg, 1 inhalation twice daily plus additional inhalations as needed (n=1,107); 2) salmeterol/fluticasone 25/125 mcg, 2 inhalations twice daily plus terbutaline as needed (n=1,123); or 3) budesonide/formoterol 320/9 mcg, 1 inhalation twice daily plus terbutaline as needed (n=1,105).

After 6 months of patient follow-up, the time to first severe exacerbation was greater among patients receiving budesonide/formoterol 160/4.5 mcg compared with patients receiving salmeterol/fluticasone plus terbutaline (P=.0034) and budesonide/formoterol 320/9 mcg plus terbutaline (P=.023). Patients receiving budesonide/formoterol 160/4.5 mcg also experienced fewer total exacerbations compared with patients receiving salmeterol/fluticasone plus terbutaline (rate reduction=0.61; 95% CI, 0.49–0.76; P<.001) and those receiving budesonide/formoterol 320/9 mcg plus terbutaline (rate reduction=0.72; 95% CI, 0.57–0.90; P=.0048).

Little difference was demonstrated in the day-to-day control of asthma among treatment groups. All treatments demonstrated statistically similar improvements in lung function, asthma control days, and asthma-related quality-of-life. All 3 treatment strategies were well tolerated.

The authors noted that budesonide/formoterol 160/4.5 mcg was demonstrated to be superior to the other regimens despite the fact that the combination provided 25% less ICS than the fixed-dose regimens. They stated that the use of budesonide/formoterol 160/4.5 mcg, due to the simplicity and efficacy of the regimen, as demonstrated in this study, offers a significantly better treatment option compared with "fixed, twice-daily combinations of higher-dose ICS/[long-acting beta2-agonists], which have until now been regarded as the most effective way to manage moderate and severe persistent asthma."

SOURCES

Kuna P, Peters MJ, Manjra AI, et al. Effect of budesonide/formoterol maintenance and reliever therapy on asthma exacerbations. Int J Clin Pract. 2007; 61:725–736.

Expert Panel Report 2: Guidelines for diagnosis and management of asthma. National Institutes of Health National Heart Lung and Blood Institute website. 2002. http:// http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf. Accessed July 10, 2007.