Co-morbidity and Refractory Asthma - UK Severe Asthma Registry (UKSAR)

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma

Detailed Description

There are currently 14 Networks of UK dedicated Specialist Difficult Asthma Services submitting data to the UK Registry: Belfast City Hospital; Royal Brompton & Harefield, London; Birmingham Regional Severe Asthma Service; South Thames & Kent Severe Asthma Service; East Midlands Severe Asthma Network; North West Midlands Severe Asthma Service; Yorkshire Asthma MDT; East of England Severe Asthma Network; Wessex Severe Asthma Network; South West Asthma Network; North West Asthma Network, Newcastle Severe Asthma Network and Greater Glasgow & Clyde.

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.

• Study Type: Observational
• Enrollment (Anticipated): 4800

Contacts and Locations

• Study Contact: Name: Liam Heaney; Phone Number: +44 (0)28 9097 6376; Email: l.heaney@qub.ac.uk

Study Locations

• United Kingdom
  • Belfast, United Kingdom
    • Recruiting
    • Queen's University Belfast
    • Contact: Liam G Heaney; Phone Number: ‪028 9097 6376; Email: l.heaney@qub.a.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria: None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with no systemic corticosteroid exposure in most recent 12 month follow-up period	5 years

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• UK SAR Database with list of active projects

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2020
• Primary Completion (Anticipated): August 26, 2025
• Study Completion (Anticipated): August 26, 2025

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: DB/SAR2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No