NCT02059434

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)
• Asthma

Interventions

Type	Name	Description
DRUG	LAS190792 Dose 1
DRUG	LAS190792 Dose 2
DRUG	LAS190792 Dose 3
DRUG	LAS190792 Dose 4
DRUG	LAS190792 Dose 5
DRUG	LAS190792 Dose 6
DRUG	LAS190792 Dose 1 (Part 2)
DRUG	LAS190792 Dose 2 (Part 2)
DRUG	Tiotropium 18 μg
DRUG	Indacaterol 150 μg
DRUG	Placebo

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-10-06
• Completion: 2014-10-06
• First posted: 2014-02-11
• Last updated: 2019-06-21
• Results posted: 2019-06-21

Locations

2 sites across 1 country: United Kingdom