Efficacy, Pharmacokinetics, Safety & Tolerability of Inhaled AZD8871
Research type
Research Study
Full title
A Phase IIa, Randomised, Multi-centre, Double-blind, Placebo and Active-controlled, 3 Periods, Crossover Study to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of Inhaled AZD8871 Administered Once Daily for 2 Weeks in Patients with Moderate to Severe COPD
IRAS ID
249363
Contact name
Manoj Satyavarapu
Contact email
Eudract number
2018-001722-25
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Chronic obstructive pulmonary disease(COPD) is a significant cause of morbidity and mortality worldwide (Global Initiative for Chronic Obstructive Lung Disease [GOLD 2018]). It is a common, preventable and treatable disease characterised by persistent airflow limitations.
In this study AstraZeneca (study sponsor) is looking to evaluate the efficacy, pharmacokinetics (PK:movement of drug in the body) and safety of AZD8871 (which is an unlicensed drug to treat patients with COPD).
The study will consist of a Screening period, 3 treatment periods (AZD8871, Anoro Ellipta & Placebo each separated by a wash out period), and a Follow-up Visit. The study has a “crossover” design, participants will receive each of the 3 treatments during the study, 1 per each of the three 2-week treatment periods. The order of the treatments will be randomly determined by a computer.
The study will be performed in adult male and non-childbearing female participants aged 40 to 85 years (both inclusive) with moderate to severe COPD and will be conducted at approximately 5 sites across Germany and the United Kingdom (UK).
Approximately 145 participants will be screened in order to randomise 72 participants into the study. A sub-group of 36 participants will undergo Pharmacokinetic(PK) assessments .
REC name
South Central - Berkshire Research Ethics Committee
REC reference
18/SC/0434
Date of REC Opinion
4 Sep 2018
REC opinion
Favourable Opinion