Professor Judy Bradley
Name of the study
BronchUK: Clinimetric Properties of Outcome Measures in Bronchiectasis in the UK
Aim of the research:
The aim of this study is to explore the clinimetric properties of a range of outcome measures, in order to make recommendations for their use in clinical trials in bronchiectasis. These measures include: lung function (spirometry, lung clearance index); health related quality of life (HRQoL) assessment [St Georges Respiratory Questionnaire (SGRQ); Quality of Life - Bronchiectasis (QOL-B) Questionnaire; EuroQol (EQ-5D-5L)]; and, blood (white cell count, c-reactive protein) and sputum (microbiology, inflammatory markers) processing.
Background to the research:
Bronchiectasis is a persistent or progressive condition characterised by dilated thick-walled bronchi. The management of bronchiectasis incorporates an intense regime of prevention and treatment. These often include daily intake of inhaled and nebulised medications, antibiotic therapy, airway clearance, visits to GP and/or respiratory clinics and hospitalisation. The burden of treatment associated with bronchiectasis is therefore significant and is provided at a huge economic cost to the health service. Many of these treatments are provided in the absence of a sound evidence base and so there is a clear need to develop assessment tools for use both in clinical trials and in clinical practice. There is an increasing demand for researchers and regulatory bodies to use robust outcome measures in clinical trials which have evidence of validity, reliability, and responsiveness. There is currently little agreement on the core clinical endpoints that should be used in bronchiectasis. This study is being funded by a MRC, Bronchiectasis Infrastructure Grant and is sponsored by Queen’s University Belfast.
What the study involves:
The study involves attending the Northern Ireland Clinical Research Facility (NICRF) to take part in four visits over the course of a year, at four monthly intervals. All the visits will take the same format and include the same tests, i.e. participants will complete 3 questionnaires, lung function (breathing tests), and provide a sputum and blood sample.
During this one year period if participants have a chest infection which requires them to take antibiotic therapy they will be asked to attend the NICRF on two additional occasions. The first visit will take place 48 hours after starting antibiotic treatment and the second within two weeks of completing antibiotic treatment. These visits will follow the same procedure as previous visits.
Who can take part in the study:
Participants with bronchiectasis may take part in this study. There are specific eligibility criteria that the research team will check to ensure participants are suitable for the study. This is a UK study and the research is being conducted within the hospital setting. For a full list of sites please see ClinicalTrials.gov where there will be up to date information on all sites involved and their current recruitment status.
This study is a multicentre observational study in adult bronchiectasis.
If you think you might be suitable and would be interested in taking part, please use the contact information below.
Contact Information For Professor Judy Bradley / Dr Kathryn McDowell
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