Role of budesonide/formoterol maintenance and reliever therapy: a pragmatic study.

BACKGROUND Many studies have demonstrated the efficacy of budesonide/formoterol (BUD/FORM) for Maintenance and Reliever Therapy (SMART®) for asthma control. However, there are concerns regarding its over-use and effectiveness. OBJECTIVE To examine asthma control and over-use of BUD/FORM in real-life situations. METHODS This study was a hospital-based cross-sectional and multi-center design. Patients were enrolled if they were >12 years old, had persistent asthma, had received BUD/FORM SMART for 3 months or longer, and smoked less than 10 pack-year. RESULTS Of the 792 patients who used BUD/FORM for a mean of 28.2 months, all used BUD/FORM as maintenance and only 22.2% of the patients required BUD/FORM to relieve symptoms. The average inhaled corticosteroid dose used was 355.3±154.9μg/day (95% CI: 344.5 to 366.1). In 792 patients, constituting 2,376 person-months of observations, there was only one patient who used more than 12 puffs/ day of BUD/FORM for 3 days, with a rate of 0.015 days per patient per year (95%CI: 0.003 to 0.044), without reporting any adverse events. The percentage of asthma control according to the Asthma Control Test score of 20 or greater was 86.5% (95% CI: 84.1 to 88.9). Overall, the rates per patient per year of emergency room (ER) visits and hospital admissions were 0.18 and 0.21, respectively. CONCLUSIONS BUD/FORM SMART is effective in real-life clinical practice. On average, patients who received a low dose steroid in the form of BUD/FORM, had a satisfactorily high proportion of asthma control and had a low rate of ER visits and hospitalization. BUD/FORM maintenance and reliever therapy seems to be promising as a treatment approach for persistent asthma in every day clinical practice.