Co-morbidity and Refractory Asthma - UK Severe Asthma Registry
NCT ID: NCT04553276
Last Updated: 2021-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
4800 participants
OBSERVATIONAL
2020-08-26
2025-08-26
Brief Summary
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The UK Severe Asthma Registry has been collecting data on patients attending Severe Asthma Clinics in the UK since 2007.
After obtaining appropriate consent from patients to use their information, data is entered by the patient's own clinical team and it is kept up-to-date to follow clinical progress and response to treatments. Very strict controls are in place to make sure individuals cannot be identified from the Registry and all information available from the National Registry is anonymous.
Apart from the local clinic team, occasionally trusted third parties will also be able to identify you, if required to do so, on a strict need-to-know basis. This is necessary to ensure that the Registry works efficiently, or as a part of a Research Project, previously approved by a Research Ethics Committee.
Data from the Registry has a number of uses including judging which severe asthma treatments are of greater benefit, to identify different subgroups of severe asthma and trial new therapies and to provide information for planning future services for people with severe asthma. The use of any information from the UK Severe Asthma Registry requires approval of the Steering Committee which is made up of the refractory asthma specialists from across the UK and who will have access to data protection, legal and ethics expertise where necessary, to safeguard the use of data.
If the Registry closes, data will be returned to the local clinic team if requested, otherwise it will be destroyed. Participation is entirely voluntary and patients can withdraw consent form the Registry at any time by informing their local clinical team. The Data Controller from the UK Severe Asthma Registry is Queen's University Belfast and the Data Processor is Dendrite Clinical Services Ltd which is a commercial provider of database and registry systems.
Detailed Description
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The Registry was set up to standardise clinical services in the UK and facilitate research into patients with difficult asthma. Patients that attend difficult asthma services across the UK are approached to give consent for inclusion. The Registry is hosted online by Dendrite Clinical Systems and admits password protected anonymised data, after fully informed written consent is obtained from patients (see Patient Information and Consent sheets). The individual centre data can be downloaded locally by registered users for audit purposes. The Registry records patient demographics including gender, age at diagnosis, race, occupation, smoking status, BMI. Disease characteristics such as asthma medication, unscheduled healthcare visits, exacerbations, hospital and ICU admissions, blood and sputum investigations, allergen testing, pulmonary function are also recorded in the registry.
Subjects have been entered into the Registry in a non-selected manner and there are currently over 4800 subjects in the Registry with detailed demographic, disease characteristics and health outcome data. Of these subjects, the majority after detailed assessment fulfil the American Thoracic Society definition of refractory asthma, whilst others after detailed assessment are identified as having non-refractory asthma.
The Registry has also been expanded to collect data on bronchial thermoplasty in line with NICE Guidance on bronchial thermoplasty for severe asthma (http://www.nice.org.uk/guidance/ipg419).
the Registry with detailed demographic, disease characteristics and health outcome data.
As part of NHS England Central Commissioning for Specialist Severe Asthma Services, all specialist centres in the UK will be required to input data into the Registry to enable benchmarking between centres.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
16 Years
ALL
No
Sponsors
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Royal Brompton & Harefield NHS Foundation Trust
OTHER
University Hospital Birmingham NHS Foundation Trust
OTHER
Guy's and St Thomas' NHS Foundation Trust
OTHER
Barts & The London NHS Trust
OTHER
University Hospitals, Leicester
OTHER
Nottingham University Hospitals NHS Trust
OTHER
University Hospitals of North Midlands NHS Trust
OTHER
Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
Hull University Teaching Hospitals NHS Trust
OTHER_GOV
The Leeds Teaching Hospitals NHS Trust
OTHER
Cambridge University Hospitals NHS Foundation Trust
OTHER
University Hospital Southampton NHS Foundation Trust
OTHER
Portsmouth Hospitals NHS Trust
OTHER_GOV
Oxford University Hospitals NHS Trust
OTHER
University Hospital Plymouth NHS Trust
OTHER
University Hospitals Bristol and Weston NHS Foundation Trust
OTHER
Royal Devon and Exeter NHS Foundation Trust
OTHER
Taunton and Somerset Hospital
OTHER
Lancashire Teaching Hospitals NHS Foundation Trust
OTHER
Newcastle-upon-Tyne Hospitals NHS Trust
OTHER
NHS Greater Glasgow and Clyde
OTHER
Queen's University, Belfast
OTHER
Responsible Party
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Liam Heaney
Professor of Respiratory Medicine
Locations
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Queen's University Belfast
Belfast, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Liam G Heaney
Role: primary
Related Links
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UK SAR Database with list of active projects
Other Identifiers
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DB/SAR2020
Identifier Type: -
Identifier Source: org_study_id