Safety and Efficacy in Children with Persistent Asthma Treated with Formoterol 10 µg BID Delivered via Certihaler ™ : A Novel Multidose Dry-Powder Inhaler

Abstract

The Certihaler^™ is a new multidose dry-powder inhaler for the delivery of formoterol (Foradil^®). This study assessed the efficacy and safety of formoterol delivered via the Certihaler in children with persistent asthma (baseline forced expiratory volume in 1 second (FEV₁) ≥50% of predicted normal values). This multicenter, randomized, double-blind, parallel- group 12-week study evaluated the safety and efficacy of formoterol via the Certihaler in 249 children (5–13 years old) with persistent asthma. Patients were randomized to receive either formoterol 10 µg BID (n = 127) or placebo BID (n = 122) for 12 weeks. The primary efficacy variable was the 12-hour area under the curve (AUC) of FEV₁ at 12 weeks. Patients treated with formoterol via the Certihaler experienced statistically significant increases in 12-hour AUC of FEV₁ after 12 weeks' treatment compared with placebo (treatment difference 0.95 L · h, 95% CI 0.21, 1.70; p < 0.012). Serial FEV₁ measurements showed formoterol to have a rapid onset of action (<5 minutes) with significant differences compared with placebo from 5 minutes (p < 0.001) to 6 hours (p < 0.017). Significant increases in morning PEF were observed in the formoterol group compared with placebo (p < 0.05). Nocturnal asthma symptom scores improved with formoterol treatment (p < 0.018); no difference in rescue medication use was detected between the groups. Treatment with formoterol was well tolerated. Formoterol delivered via the Certihaler is an effective and well-tolerated bronchodilator for the treatment of children with persistent asthma. (Pediatr Asthma Allergy Immunol 2005; 18[1]:25–35.)