Clinical trial NCT04553276: Co-morbidity and Refractory Asthma - UK Severe Asthma Registry
Official title: Co-morbidity and Refractory Asthma - UK Severe Asthma Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: Royal Brompton & Harefield NHS Foundation Trust
name: University Hospital Birmingham NHS Foundation Trust
name: Guy's and St Thomas' NHS Foundation Trust
name: Barts & The London NHS Trust
name: University Hospitals, Leicester
name: Nottingham University Hospitals NHS Trust
name: University Hospitals of North Midlands NHS Trust
name: Sheffield Teaching Hospitals NHS Foundation Trust
name: Hull University Teaching Hospitals NHS Trust
name: The Leeds Teaching Hospitals NHS Trust
name: Cambridge University Hospitals NHS Foundation Trust
name: University Hospital Southampton NHS Foundation Trust
name: Portsmouth Hospitals NHS Trust
name: Oxford University Hospitals NHS Trust
name: University Hospital Plymouth NHS Trust
name: University Hospitals Bristol and Weston NHS Foundation Trust
name: Royal Devon and Exeter NHS Foundation Trust
name: Taunton and Somerset Hospital
name: Lancashire Teaching Hospitals NHS Foundation Trust
name: Newcastle-upon-Tyne Hospitals NHS Trust
name: NHS Greater Glasgow and Clyde
First posted: 2020-09-17
Enrollment: 4800
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria: None

Primary outcomes:
measure: Proportion of patients with no systemic corticosteroid exposure in most recent 12 month follow-up period
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Queen's University Belfast
Study officials:
References: