Asthma Clinical Trial
Official title:
A 2-Part, Randomised, Placebo-Controlled, Safety, Tolerability, Pharmacokinetic And Pharmacodynamic Study Of LAS190792 Delivered By Inhalation In Asthmatic And Chronic Obstructive Pulmonary Disease (COPD) Subjects
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).
This study is an integrated Phase I protocol divided into 2 parts.
Part one: a single ascending dose study (6 LAS190792 dose levels) in 16 male subjects with
mild asthma. LAS190792 will be administered (by the Genuair® inhaler) under supervision at
the study centre, according to the randomisation scheme. One dose level will be administered
per week with 2 to 3 weeks between each dose level for the safety and pharmacokinetic data
review.
Part two: A 5-way , crossover, single dose study (of LAS190792 [two doses], indacaterol,
tiotropium and placebo) in 40 male and non-childbearing potential women subjects with
moderate to severe COPD. Each treatment period will be separated by a washout period of at
least 7 to 14 days. The aim is to ensure at least 30 subjects complete Part 2 of the study.
The primary comparison for bronchodilation will be between LAS190792 doses and placebo. Other
treatment comparisons (indacaterol or tiotropium vs placebo and LAS190792 vs indacaterol or
tiotropium) will be considered additional.
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