PRESTO
Research type
Research Study
Full title
A Multicentre, Parallel-group, Phase IIb, Randomised, Double-blind, Placebo-controlled, 4-Arm, 24-Week Study to Evaluate the Efficacy and Safety of AZD6793 Tablets in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PRESTO)
IRAS ID
1012202
Contact name
Pierfrancesco Lanzilotti
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2025-520473-40
Research summary
This AstraZeneca Pharmaceuticals research study aims to learn more about how safe a new investigational drug called AZD6793 is, find the optimal dose and how well it works in adults with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD).
Despite the existing treatments for COPD, many people still experience significant flare-ups, also called exacerbations, that require additional treatments such as steroids and/or antibiotics.
To participate in this study, you need to be at least 40 years of age, have a confirmed COPD diagnosis, and have experienced at least 2 moderate exacerbations or 1 severe exacerbation in the past 12 months. You must also be receiving the current standard therapy COPD.
Qualified participants will be randomly divided into four groups to receive low, medium and high dose of AZD6793 or placebo (a pill that looks like AZD6793 but contains no medication) in addition to their usual therapy for COPD. Neither you nor the study team will know who is receiving AZD6793 or placebo. Participants might not directly benefit from the study, but if AZD6793 works, it may help reduce COPD flare-ups and slow down the disease from getting any worse.
The study lasts for up to 30 weeks and will be divided into three stages: screening (4 weeks to check if you qualify), treatment (24 weeks) and follow-up (2 weeks). There will be up to 9 visits in total. The research will take place in the UK and other countries.
During the study, participants will undergo several procedures, such as lung function test (spirometry), ECG, skin and hair examination for depigmentation (loss of colour), computer tomography (CT) scan, general health check, and blood, urine, nasal, and phlegm samples will be taken. Some procedures are optional or applicable for participants taking part in sub-studies. You will also complete some questionnaires about your symptoms and medication use.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
25/SC/0188
Date of REC Opinion
14 Jul 2025
REC opinion
Further Information Favourable Opinion