Two-part Pharmacokinetic and Pharmacodynamic Study of LAS190792 in Patients With Asthma and COPD

Summary

The purpose of this study is to assess the safety and tolerability of single doses of LAS190792 administered by inhalation to patients with mild persistent asthma and moderate to severe chronic obstructive pulmonary disease (COPD) and also to assess the ability of LAS190792 to produce bronchodilation (opening of the airways).

Timeline

Start

2013-09-01

Primary completion

2014-10-06

Completion

2014-10-06

Outcome

Met primary endpoint

registry analysis (superiority or other test); LAS190792 100 µg (Part 2) vs Placebo (Part 2); p <0.0001; Least squares mean difference 0.104 (95% CI 0.060 to 0.149) NCT02059434 ↗

registry analysis (superiority or other test); LAS190792 400 µg (Part 2) vs Placebo (Part 2); p <0.0001; Least squares mean difference 0.178 (95% CI 0.133 to 0.223) NCT02059434 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Indacaterol	Other / unclassified	150 ug	Inhaled
Subject	LAS190792	Small molecule	—	Inhaled
Comparator	Tiotropium	Other / unclassified	18 ug	Inhaled

Indications