Efficacy and safety of abediterol, a long-acting β2-adrenergic agonist (LABA); three phase II trials in asthma

Background Abediterol (LAS100977) is a novel LABA in development as a fixed dose combination with an inhaled corticosteroid for the treatment of asthma and COPD. We report efficacy and safety data from three Phase II trials of abediterol in patients with persistent, stable asthma. Methods Abediterol was assessed in three randomized, double-blind, placebo-controlled, crossover trials. Single doses were administered in the morning via Cyclohaler ® (Study 1 and 2) or Genuair ® (Study 3). Studies 1 and 3 had active comparators (salmeterol and salbutamol, respectively). Change from baseline in FEV 1 was assessed and treatment emergent adverse events (TEAEs) were recorded. Results In total, 25, 28 and 62 patients were randomized to treatment in Studies 1, 2 and 3, respectively (all male in Studies 1 and 2). Over a range of doses (0.313, 0.625, 1.25, 2.5, 5, 10 and 25 µg), abediterol produced rapid (≤ 15 minutes post-dose), sustained, clinically significant bronchodilation versus placebo. Trough FEV 1 was significantly higher with all doses of abediterol versus placebo (table). TEAEs were consistent with the drug class and most were mild to moderate in intensity. Conclusion Abediterol was generally safe and well tolerated, producing rapid, sustained, clinically significant improvements in bronchodilation versus placebo in patients with asthma.