CRESCENDO
Research type
Research Study
Full title
A Phase IIa Randomised, Double-Blind, Placebo Controlled, Parallel Arm, Multi-Centre Study to Evaluate the Efficacy and Safety of AZD4831, for 12-24 Weeks, in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
IRAS ID
1006281
Contact name
Åsa Rosqvist
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2022-002441-18
Clinicaltrials.gov Identifier
Research summary
This is a clinical trial funded by AstraZeneca to assess the efficacy (whether it works) and safety of an investigational drug called AZD4831 for the treatment of Chronic Obstructive Pulmonary Disease (COPD). Despite current standard therapy for COPD some patients continue to experience significant ongoing symptoms and/or flare ups requiring treatment with steroids and/or antibiotics.
Participants in this study will be aged 40-80 years of age, have a confirmed diagnosis of COPD, have at least 1 flare up in the last 2 years and receive current standard therapy for COPD. Suitable participants will be randomly assigned to receive either AZD4831 or placebo (which looks like AZD4831 but contains no medication) in addition to their current standard therapy for COPD. Neither participants nor the study staff assessing them will know whether they have received AZD4831 or placebo. It is not certain that participants will directly benefit from the participation in the study. If AZD4831 works, the potential benefit for COPD patients in the future is that it will reduce COPD flare up, and therefore stopping the disease from getting any worse.
The study lasts for up to 30 weeks across three stages: screening (to assess suitability for the study), treatment and follow up, with a total of up to 8 visits. It will be conducted in the UK and other countries. The study will be conducted at commercial research sites, hospitals and GP surgeries.
During the study, participants will undergo various procedures including lung function testing, computer tomography (CT) scan, blood, urine, nasal and phlegm samples will be taken.
Participants will also complete various questionnaires about their symptoms and medication usage.REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/LO/0745
Date of REC Opinion
22 Nov 2022
REC opinion
Further Information Favourable Opinion