RT Journal Article
SR Electronic
T1 Efficacy and safety of abediterol (LAS100977) in patients with COPD: Phase II, randomised, crossover study
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 183
VO 42
IS Suppl 57
A1 Jutta Beier
A1 Helena Pujol
A1 Beatriz Seoane
A1 Eulalia Jimenez
A1 Carol Astbury
A1 Sandrine Ruiz
A1 Gonzalo de Miquel
YR 2013
UL http://erj.ersjournals.com/content/42/Suppl_57/183.abstract
AB Background: The bronchodilatory efficacy and safety of single doses of once-daily abediterol, a novel LABA in development for the treatment of asthma and COPD, vs placebo and indacaterol in patients with moderate-to-severe COPD were assessed.Methods: Adult patients with COPD (mean FEV1 1.72 L; 58.0% predicted [post-BD]) received single doses of abediterol 0.625, 2.5, 5 and 10 µg via Genuair®, indacaterol 150 µg via Breezhaler® and placebo in a 6-period crossover study. The primary endpoint was change from baseline to trough FEV1. Secondary endpoints included change from baseline in normalized FEV1 AUC0-24, and peak FEV1. Safety, tolerability and abediterol pharmacokinetics (subgroup analysis) were assessed.Results: A total of 63/70 randomized patients completed the study. Lung-function data are summarized (Table). The percentage of patients with ≥1 IMP-related TEAE was ≤3% for each abediterol dose; similar to placebo (2.9%) and indacaterol 150 µg (2.9%). Peak abediterol plasma concentration was reached within 0.5–1.5 h post-dose (n=20). Dose proportionality in Cmax and AUC(0-t) was observed.View this table:Table. Change from baseline (LS means difference vs placebo), LConclusions: Single inhaled doses of abediterol 0.625–10 µg induced and maintained significant bronchodilation vs placebo and were well tolerated. The bronchodilatory effect of abediterol 2.5, 5 and 10 µg was significantly greater than indacaterol 150 µg.