CORAL
Research type
Research Study
Full title
A 12-week Exploratory Study to Characterise the RelatiOnship Between Changes in InflammatoRy Markers, Lung Function, Symptoms And ReLiever Use in Chronic Obstructive Pulmonary Disease Patients (CORAL)
IRAS ID
259885
Contact name
Mona Bafadhel
Contact email
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
The purpose of this open-label, single-arm, single-site exploratory study is to gain longitudinal insights into the relationships between the inflammatory profile, symptoms, lung function, and reliever use in subjects with chronic obstructive pulmonary disease (COPD). The clinical hypothesis is that episodes of COPD symptom deteriorations are preceded by an increase in airway inflammation. The reason for the study is to have a better understanding of what happens to patients’ symptoms, breathing tests and markers of inflammation on a day-to-day and week-to-week basis. This information will increase our understanding about COPD and how we may design new treatments for COPD.\n \nPatients in this study will be asked to switch to Ventolin® and Duaklir® for the duration of the study to achieve standardisation. They will be invited to attend a minimum of 8 clinic visits. They will consist of a Screening Visit (Visit 1), a 4-week run-in period, a Baseline Visit (Visit 2) and a 12-week observational period, including 6 visits scheduled every 2 weeks. During the observational period, additional visits may occur if subjects experience a worsening of their COPD symptoms. For each individual subject, the duration of participation in the study will be 16 weeks.\nThe study will be conducted at the Oxford University Hospitals NHS Foundation Trust and coordinated by the Oxford Respiratory Trials Unit (ORTU), University of Oxford.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
19/SC/0417
Date of REC Opinion
1 Oct 2019
REC opinion
Further Information Favourable Opinion