Efficacy and Safety of Formoterol Delivered Via a New Multidose Dry Powder Inhaler (Certihaler™) in Adolescents and Adults with Persistent Asthma

Our objective was to compare the efficacy and safety of formoterol (Foradil®) delivered via a novel multidose dry powder inhaler (Certihaler™) with placebo and albuterol [pressurized metered-dose inhaler (pMDI)], in patients with persistent asthma. After a 2-week run-in phase, 265 patients (13–81 years) previously treated with regular/PRN bronchodilators for persistent asthma were randomized to 12 weeks' double-blind treatment with formoterol 10 µg BID via Certihaler (n = 86), albuterol 180 µg QID via pMDI (n = 88) or placebo (n = 91). The primary efficacy variable was 12-hour AUC of FEV1 after 12 weeks' treatment. Secondary efficacy variables included peak expiratory flow (PEF), rescue bronchodilator medication use, asthma-related quality of life (Juniper Mini Asthma Quality of Life Questionnaire), and asthma symptom scores. Formoterol via the Certihaler had an onset of action within 5 minutes and was associated with a clinically relevant and statistically significant increase in 12-hour AUC of FEV1 afte...