Comparable efficacy and tolerability of formoterol (Foradil®) administered via a novel multi-dose dry powder inhaler (Certihaler™) or the Aerolizer® dry powder inhaler in patients with persistent asthma

Background: For maximum treatment compliance there is a need to provide asthma patients with devices that suit their particular preferences. The Foradil(R) Certihaler(TM) is a novel multi-dose dry powder inhaler developed to increase the choice of devices available. Objectives: To evaluate the safety and efficacy of formoterol administered via the Foradil Certihaler, or via the single-dose inhaler Foradil(R) Aerolizer(R). Methods: This was a randomized, placebo-controlled, double-dummy, incomplete block crossover, dose-ranging and pharmacokinetic study in patients with persistent asthma. Sixty-seven patients (mean 48.0 years) were randomized to formoterol 5, 10, 15 and 30 mug twice daily via the Certihaler, 12 mug formoterol b.i.d. via the Aerolizer, or placebo in four 1-week double-blind treatment periods separated by 1-week single-blind washouts. Results: All formoterol doses delivered via the Certihaler or the Aerolizer significantly increased FEV1 compared with placebo (p < 0.0001). Formoterol demonstrated an onset of action of <3 min. All active treatments were well tolerated. Tremor was the most common adverse event and was more pronounced at high doses. At lower doses the incidence of tremor with the Certihaler was similar to that observed with placebo or the Aerolizer. The pharmacokinetic evaluation comprised 41 patients (mean 45.9 years). Urinary excretion of unchanged formoterol and total formoterol increased with dose delivered via the Certihaler. The optimum dose of formoterol via the Certihaler was 10 mug. Conclusion: Delivery of formoterol via the Certihaler or Aerolizer combines rapid relief with enduring control and provides convenient bronchodilation in patients with persistent asthma. Copyright (C) 2004 S. Karger AG, Basel.