Single Dose Study to Assess Efficacy, Safety and Tolerability of LAS100977 in Asthmatic Patients.

Phase 2 Completed 62 enrolled AstraZeneca

RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this study is to evaluate the pharmacodynamics of single doses of inhaled LAS100977 QD in patients with persistent asthma.

Timeline

Start: 2011-08-01
Primary completion: 2012-02-01
Completion: 2012-02-01

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs LAS100977 2.5 μg; p <0.0001; Least Squares Mean DIfference 0.405 (95% CI 0.353 to 0.458); ANCOVA NCT01425801 ↗

paper Abediterol produced dose-dependent improvements in peak FEV1 from baseline compared with placebo PMID 25398689 ↗

Publications

Singh D, Pujol H, Ribera A, Seoane B, Massana E, Astbury C, Ruiz S, de Miquel G. A dose-ranging study of the bronchodilator effects of abediterol (LAS100977), a long-acting beta2-adrenergic agonist, in asthma; a Phase II, randomized study. BMC Pulm Med. 2014 Nov 14;14:176. doi: 10.1186/1471-2466-14-176.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abediterol	Small molecule	0.313 ug	Inhaled
Subject	Abediterol	Small molecule	0.625 ug	Inhaled
Subject	Abediterol	Small molecule	1.25 ug	Inhaled
Subject	Abediterol	Small molecule	2.5 ug	Inhaled
Comparator	Salbutamol	Unknown	400 ug	Inhaled