PT  - JOURNAL ARTICLE
AU  - Jutta Beier
AU  - Rainard Fuhr
AU  - Beatriz Seoane
AU  - Eric Massana
AU  - Gonzalo De Miquel
AU  - Helena Pujol
AU  - Sandrine Ruiz
TI  - Abediterol in stable asthma:efficacy, safety and tolerability results from a Phase II, randomised, crossover study
DP  - 2014 Sep 01
TA  - European Respiratory Journal
PG  - P902
VI  - 44
IP  - Suppl 58
4099  - http://erj.ersjournals.com/content/44/Suppl_58/P902.short
4100  - http://erj.ersjournals.com/content/44/Suppl_58/P902.full
SO  - Eur Respir J2014 Sep 01; 44
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.