Co-morbidity and Refractory Asthma - UK Severe Asthma Registry

NCT04553276 | Unknown

• 1 other identifier: DB/SAR2020
• Study Type: observational
• Target: 4,800
• Locations: 1 country
• Sites: 1

Brief Summary

A "Clinical Registry" is a database which contains clinical information about people with different medical conditions. They are used in many countries throughout the world to help medical teams to better understand specific diseases and improve the care and treatment of patients. 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with no systemic corticosteroid exposure in most recent 12 month follow-up period

  5 years

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that are referred to specialist severe asthma services across the UK. The majority of patients after detailed assessment fulfill the American Thoracic Society definition of refractory asthma, whilst others after detailed assessment are identified as having non-refractory asthma.

You may qualify if:

• \. Referral to a specialist severe asthma clinic in the UK due to inadequate asthma control

Sponsors & Collaborators

• Queen's University, Belfast: lead
• Royal Brompton & Harefield NHS Foundation Trust: collaborator
• University Hospital Birmingham NHS Foundation Trust: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Barts & The London NHS Trust: collaborator
• University Hospitals, Leicester: collaborator
• Nottingham University Hospitals NHS Trust: collaborator
• University Hospitals of North Midlands NHS Trust: collaborator
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator
• Hull University Teaching Hospitals NHS Trust: collaborator
• The Leeds Teaching Hospitals NHS Trust: collaborator
• Cambridge University Hospitals NHS Foundation Trust: collaborator
• University Hospital Southampton NHS Foundation Trust: collaborator
• Portsmouth Hospitals NHS Trust: collaborator
• Oxford University Hospitals NHS Trust: collaborator
• University Hospital Plymouth NHS Trust: collaborator
• University Hospitals Bristol and Weston NHS Foundation Trust: collaborator
• Royal Devon and Exeter NHS Foundation Trust: collaborator
• Taunton and Somerset Hospital: collaborator
• Lancashire Teaching Hospitals NHS Foundation Trust: collaborator
• Newcastle-upon-Tyne Hospitals NHS Trust: collaborator
• NHS Greater Glasgow and Clyde: collaborator

Study Sites (1)

Queen's University Belfast

Belfast, United Kingdom

RECRUITING

Related Links

• UK SAR Database with list of active projects

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Liam Heaney

CONTACT

+44 (0)28 9097 6376; l.heaney@qub.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Respiratory Medicine

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 17, 2020
• Study Start: August 26, 2020
• Primary Completion: August 26, 2025
• Study Completion: August 26, 2025
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)