Single inhaler Therapy with budesonide/formoterol reduces the risk of severe exacerbations compared with budesonide plus terbutaline as needed in patients with asthma☆

Abstract Rationale We hypothesized that a once-daily base dose of budesonide/formoterol in a single inhaler (Symbicort ® ), plus additional doses as needed to provide improved control and immediate relief of symptoms (Single inhaler Therapy), would reduce the risk of severe exacerbations compared with a higher fixed dose of budesonide plus as-needed terbutaline. Methods This was a 12-month, randomized, double-blind, parallel-group study. Symptomatic patients (n=1890; mean age 43 [range 11-80] years, mean baseline FEV 1 70% predicted normal, mean ICS dose 746μg/day) received either a daily base dose of budesonide/formoterol (160/4.5μg, 2 inhalations once daily) with additional inhalations (=10/day) as needed for relief of symptoms, or budesonide (160μg, 2 inhalations twice daily) plus as-needed terbutaline 0.4mg. We assessed the risk of severe exacerbations (defined as hospitalization/emergency room [ER] treatment, oral steroids due to asthma worsening, or morning PEF=70% of baseline on 2 consecutive days), as-needed medication use, and tolerability. Results The budesonide/formoterol group had a 39% lower risk of a severe exacerbation compared with the budesonide group (p Conclusions Single inhaler Therapy with a once-daily base dose of budesonide/formoterol plus additional inhalations as needed significantly reduces the risk of severe exacerbations compared with a higher fixed dose of budesonide plus terbutaline.