Asthma (Part 1) Clinical Trial
Official title:
A 2-part, Randomised, Placebo-controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of AZD8871 Delivered by Inhalation in Asthmatic and Chronic Obstructive Pulmonary Disease (COPD) Subjects
This is a phase I, randomised, placebo-controlled 2-part study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8871 delivered by inhalation, in asthmatic and chronic obstructive pulmonary disease (COPD) subjects.
This study is an integrated Phase I protocol divided into 2 parts.
Part 1: single ascending dose study (6 AZD8871 dose levels) in 16 male subjects with mild
asthma. AZD8871 will be administered (by the Genuair® inhaler) under supervision at the study
centre, according to the randomisation scheme
Part 2: a 5 treatment period single dose study (of AZD8871 [two doses], indacaterol,
tiotropium and placebo) in 40 male and non-childbearing female subjects with moderate to
severe COPD. Each treatment period will be separated by a washout period of at least 7 days.
The primary comparison for bronchodilation will be between AZD8871 doses and placebo.
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