Study Design: Randomised Controlled Trial
Disease Area: Respiratory
Funder: Astra Zeneca UK
Sponsor: Hull Teaching Hospitals NHS Trust
Chief Investigator: Professor Michael Crooks
Trial registration: ISRCTN 29148209
An investigation into the effect of inhaled combined BUD/GLY/FORM on platelets in COPD as a potential cardioprotective mechanism: an exploratory, single-centre, laboratory-blind, randomised controlled cross-over trial (COPD CardioProtect)
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Project overview
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Trial Team
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Participating Sites
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Patient Information
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Dissemination
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 steroid-containing 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.
What we plan to do
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 adults with COPD from the Hull University Teaching Hospitals NHS Trust. Each participant will remain in the trial for 16 weeks.
Chief Investigator
Prof Micheal Crooks Professor of Respiratory Medicine - Castle Hill Hospital,
HHTU Study team
Matthew Northgraves - Trial Manager
Amy Bromby - Trial Coordinator
Bronwen Williams - Operations Manager
Laura Simms - Data Manager
Kerri Morris - Trial Administrator
Judith Cohen - HHTU Director
Collaborators
Dr Simon Calaminus - Hull York Medical School
Prof Alyn H Morice Professor of Respiratory Medicine - Hull York Medical School
Prof Simon Hart Professor of Respiratory Medicine - Hull York Medical School
Dr Dominic Sykes - Hull University Teaching Hopsitals NHS Trust
Email address
copd-cardioprotect@hyms.ac.uk
Participating Sites and their Project Investigators
Hull University Teaching Hospitals NHS Trust - Professor Michael Crooks
Watch this space.