A Two Part study of AZD8871 in asthmatic and COPD subjects
Research type
Research Study
Full 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
IRAS ID
187023
Contact name
Deepan Nathan
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2015-002906-36
Duration of Study in the UK
0 years, 11 months, 17 days
Research summary
This first in human study drug does not yet have a name and is known as AZD8871. It is hoped it will be useful as a treatment for asthma and Chronic Obstructive Pulmonary Disease (COPD). AZD8871 works as a bronchodilator by relaxing the smooth muscles of the airway to decrease resistance in the respiratory airway associated with COPD and by increasing the airflow to the lungs.
Part 1 of the study will recruit 16 non-smoking males with mild persistent asthma, between the ages of 18 and 70 years, who are able to change their current asthma treatment.
Participants receive the study medication as a single oral inhalation given via Genuair® dry powder inhaler (DPI) administered over three (three-day) treatment periods, the total duration for participants is eleven weeks.
Part 2 of the study will recruit males and females (of non-childbearing potential) with moderate to severe COPD, aged 40 years and older. 40 participants will take part in this part of the study. (If required additional participants, up to a maximum of 45 participants to be recruited).
Participants will receive two doses of study drug (dose A and dose B) as single oral inhalations using Genuair® single-dose dry powder inhaler (DPI) and a drug called indacaterol via Onbrez Breezhaler® single-dose dry powder inhaler and a drug called tiotropium via HandiHaler® single-dose dry powder inhaler. Administration is over five (three-day) treatment periods, the total duration for participants is eleven weeks.
This study will take place at the PAREXEL Early Phase Clinical Unit, London and at the Medicines Evaluation Unit (MEU), Manchester.
A full medical history, vital signs (blood pressure and body temperature), ECG measurements, physical examinations, lung function, blood, and urine safety tests will be performed. Adverse events and concomitant medications will also be monitored throughout the entire investigational period.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
15/EE/0329
Date of REC Opinion
27 Oct 2015
REC opinion
Further Information Favourable Opinion