Real-life use of budesonide/formoterol in clinical practice: a 12-month follow-up assessment in a multi-national study of asthma patients established on single-inhaler maintenance and reliever therapy

Objective: The efficacy and safety of budesonide/formoterol maintenance and reliever therapy (MRT) has been demonstrated in phase III clinical studies, but limited data are available in a real-life setting. We examined the pattern of maintenance and as-needed inhaler use in routine clinical practice among patients with asthma receiving budesonide/formoterol MRT (NCT00505388). Methods: This 12-month European observational study enrolled patients prescribed budesonide/formoterol MRT and grouped them based on regimen: 80/4.5 µg one inhalation twice daily (b.i.d.); 160/4.5 µg one inhalation b.i.d.; 160/4.5 µg two inhalations b.i.d. (all plus as needed). Patient data were collected daily using an interactive voice- or web-response system. The primary outcome measure was total number of budesonide/formoterol inhalations/day. Results: Overall, 4,581 patients were included (64% female; mean age 48.4 years; regimen: 80/4.5 µg, n = 119; 160/4.5 µg, n = 3,106; 2 × 160/4.5 µg, n = 1,355). Mean (median) total numbers of budesonide/formoterol inhalations/day were 2.48 (2.11), 2.53 (2.14), and 4.27 (4.05) for 80/4.5 µg b.i.d., 160/4.5 µg b.i.d., and 2 × 160/4.5 µg b.i.d., respectively; corresponding mean (median) number of as-needed inhalations/day were 0.68 (0.17), 0.73 (0.26), and 1.08 (0.45), respectively. As-needed budesonide/formoterol use was generally low with a mean of 61 – 66% of reliever-free days; over 4 reliever inhalations/day occurred on a mean of 0.4 – 2.5% of days for all budesonide/formoterol MRT regimens. Conclusions: In routine clinical practice, all budesonide/formoterol MRT regimens were associated with a high proportion of reliever-free days and low incidence of high reliever-use days, indicating acceptable levels of asthma control with this symptom-adjusted controller regimen.