Efficacy and safety of single therapeutic and supratherapeutic doses of indacaterol versus salmeterol and salbutamol in patients with asthma

Objective. This study compared the bronchodilator efficacy and safety of indacaterol with placebo, salbutamol and salmeterol, in patients with persistent asthma, at single therapeutic and supratherapeutic doses. Research design and methods: This was a randomised, open-label crossover study in adult subjects with asthma (forced expiratory volume in 1 second [FEV1] >= 60% predicted). In part A, patients (n = 20) received single doses of indacaterol 200 mu g, salbutamol 200 mu g, salmeterol 50 mu g and placebo. In part B, patients (n = 19) received single doses of indacaterol 1000 mu g, salbutamol 1000 mu g, salmeterol 250 mu g and placebo. Main outcomes measures; Results: For the primary endpoint, FEV, area under the effect curve during 0-24 h, indacaterol 200 mu g was statistically superior to placebo and salbutamol. Indacaterol 200 mu g FEV, was higher than placebo (5 min to 24 h), salbutamol 200 mu g (4-24 h), and salmeterol 50 mu g (5 and 15 min and 22 and 24 h). Few adverse events were reported; all were mild or moderate in severity. Initial changes were observed in glucose, potassium, heart rate and QTc interval, but all values remained within normal ranges. Values matched placebo levels after a shorter time for indacaterol 1000 mu g than for salmeterol 250 mu g. Conclusions: In this single-dose, open-label study, indacaterol 200 mu g provided effective 24-h bronchodilation, with a longer duration than saimeterol 50 mu g and a good overall safety profile. The sustained bronchodilation of indacaterol 1000 mu g was not associated with sustained systemic adverse effects.