COPD CardioProtect
Research type
Research Study
Full title
An investigation into the effect of inhaled combined BUD/GLY/FORM on platelets in COPD as a potential cardioprotective mechanism: an exploratory, single-centre, investigator-blind, randomised controlled cross-over trial
IRAS ID
1008744
Contact name
Michael Crooks
Contact email
Sponsor organisation
Hull University Teaching Hospitals NHS Trust
ISRCTN Number
ISRCTN29148209
Research summary
Chronic obstructive pulmonary disease (COPD) is a common lung disease that affects people’s breathing. People with COPD also have an increased risk of cardiovascular disease (e.g. heart disease and strokes), especially during an exacerbation (or flare-up) of COPD. Platelets are a type of blood cell that helps the blood to clot. Blood tests have shown that people with COPD have more active platelets than people without COPD. This is particularly noticeable during COPD flare-ups. This is one possible reason why people with COPD have a higher risk of having a heart attacks or strokes than people without COPD.
A recent study appeared to show that a new inhaler used to treat COPD, which contains a steroid called budesonide, provides some protection against cardiovascular disease when compared to a similar inhaler that doesn’t contain budesonide. It is important for us to improve our understanding of the link between COPD and cardiovascular disease and why adding an inhaled steroid to treatment appears to provide some protection.
The COPD CardioProtect Study will look at the effect that adding an inhaled steroid (budesonide) has on platelet activity and function in people with COPD. The trial aims to recruit 40 eligible participants with COPD from the Hull University Teaching Hospitals NHS Trust. Each participant will remain in the trial for 20-weeks. Study participants will receive both the steroid-containing and non-steroid containing inhalers at different times during the study. The order that they receive the different inhalers will be chosen at random. Participants will complete some questionnaires, breathing tests and have blood tests taken before and after receiving the study inhalers. This type of study is called a randomised, controlled, cross over trial.
REC name
London - Fulham Research Ethics Committee
REC reference
23/LO/0958
Date of REC Opinion
15 Dec 2023
REC opinion
Further Information Favourable Opinion