Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04553276 |
| Other study ID # |
DB/SAR2020 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 26, 2020 |
| Est. completion date |
August 26, 2025 |
Study information
| Verified date |
November 2021 |
| Source |
Queen's University, Belfast |
| Contact |
Liam Heaney |
| Phone |
+44 (0)28 9097 6376 |
| Email |
l.heaney[@]qub.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
