RT Journal Article
SR Electronic
T1 Abediterol in stable asthma:efficacy, safety and tolerability results from a Phase II, randomised, crossover study
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P902
VO 44
IS Suppl 58
A1 Jutta Beier
A1 Rainard Fuhr
A1 Beatriz Seoane
A1 Eric Massana
A1 Gonzalo De Miquel
A1 Helena Pujol
A1 Sandrine Ruiz
YR 2014
UL http://erj.ersjournals.com/content/44/Suppl_58/P902.abstract
AB Background:Abediterol (LAS100977), a novel, once-daily, LABA, is in development for treatment of asthma and COPD.We assessed the bronchodilatory effect of multiple-dose abediterol in male patients with persistent, mild-to-moderate asthma.Methods:Patients were randomised (1:1:1:1) to receive once-daily abediterol (2.5, 5 and 10 µg) and placebo via Cyclohaler®, plus an inhaled corticosteroid in a 7-day, 3-period crossover study.Endpoints included change from baseline in trough (Day 7) and peak FEV1 (Days 1 and 7), and safety and tolerability.Results:N=20 patients were randomised:mean age 42.7 years (SD±10.2); FEV1 pre-bronchodilator % predicted 73.2±6.3. Abediterol (all doses) significantly increased change from baseline in trough FEV1 vs placebo on Day 7 (p<0.05; Table). Change from baseline in peak FEV1 was also significant for abediterol (all doses) vs placebo on Day 1 (all p<0.001) and Day 7 (all p<0.01).Peak FEV1 was 2-4 hours post-dose.Adverse events (AE) incidence was similar across groups; 40-57% of patients reported >=1 treatment-emergent AE with abediterol vs 47% with placebo (91% were mild-to-moderate in intensity).Conclusion:Once-daily abediterol 2.5-10 μg provided clinically relevant and statistically significant improvements from baseline in trough and peak FEV1 vs placebo from first dose, with no dose-response in bronchodilation.Abediterol was safe and well tolerated.View this table:Table. Change from baseline (least squares means difference vs placebo), mLFunding:This study was supported by Almirall S.A., Barcelona, Spain.