Eformoterol Turbohaler® compared with salmeterol by dry powder inhaler in asthmatic children not controlled on inhaled corticosteroids

The aim of the study was to compare the efficacy of the inhaled long-acting beta(2)-agonists eformoterol and salmeterol when added to existing inhaled corticosteroid (ICS) therapy in symptomatic asthmatic children. This randomized, 12-week, parallel-group study, performed in a primary care setting, included 156 children and adolescents (aged 6-17 years) with moderate persistent asthma. Patients were randomized to open-label eformoterol (Oxis(R)) Turbohaler(R) 9 mug (delivered dose) or salmeterol Acculialer(R) 50 mug, both b.i.d, added to current ICS. Assessments included: changes in daytime reliever beta(2)-agonist therapy (primary variable), total 24-h reliever use, lung function, clinic and diary symptom scores, patient and carer health-related quality of life (HRQL) and adverse events. Daytime reliever use decreased significantly (p < 0.001) from baseline by 65% and 52%, respectively in the eformoterol and salmeterol treatment groups. Compared with salmeterol, eformoterol produced a greater decrease in daytime (-0.46 inhalations/ day; p = 0.081) and 24-h (-0.70 inhalations/day; p = 0.043) reliever use. The percentage of patients who did not require any reliever medication during the study was significantly higher in the eformoterol group (p < 0.05 vs. salmeterol at weeks 8 and 12). Clinic and diary card peak expiratory flow and symptom measures all improved from baseline in both treatment arms. There was a significantly greater effect in favour of eformoterol for the reduction in clinic-assessed overall night-time symptoms (p < 0.05 vs. salmeterol). Clinically relevant improvements in patient-assessed HRQL occurred during treatment with eformoterol and salmeterol, but carer-assessed HRQL was improved to a clinically relevant extent, only with eformoterol. Both treatments were well tolerated. In children and adolescents with moderate persistent asthma, add-on therapy with eformoterol was well tolerated and at least as effective as salmeterol.