AsthmaUKSARNCT04553276
Co-morbidity and Refractory Asthma - UK Severe Asthma Registry
An observational study of Asthma, run by Queen's University, Belfast at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Asthma
- How many people
- 4,800 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Aug 2020to 26 Aug 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 1. Referral to a specialist severe asthma clinic in the UK due to inadequate asthma control
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with no systemic corticosteroid exposure in most recent 12 month follow-up period
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start26 Aug 2020
- Primary completion26 Aug 2030 (estimated)
- Study completion26 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4,800 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust, University Hospital Birmingham NHS Foundation Trust, Guy's and St Thomas' NHS Foundation Trust, Barts & The London NHS Trust, University Hospitals, Leicester, Nottingham University Hospitals NHS Trust, University Hospitals of North Midlands NHS Trust, Sheffield Teaching Hospitals NHS Foundation Trust, Hull University Teaching Hospitals NHS Trust, The Leeds Teaching Hospitals NHS Trust, Cambridge University Hospitals NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, Portsmouth Hospitals NHS Trust, Oxford University Hospitals NHS Trust, University Hospital Plymouth NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust, Royal Devon and Exeter NHS Foundation Trust, Taunton and Somerset Hospital, Lancashire Teaching Hospitals NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, NHS Greater Glasgow and Clyde
- Responsible party
- Principal investigator, Liam Heaney, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553276
- Sponsor's protocol ID
- DB/SAR2020
- Acronym
- UKSAR
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2020
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-morbidity and Refractory Asthma - UK Severe Asthma Registry
- ClinicalTrials.gov ID
- NCT04553276
- Acronym / sponsor ID
- UKSAR / DB/SAR2020
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 4,800 participants (estimated)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust, University Hospital Birmingham NHS Foundation Trust, Guy's and St Thomas' NHS Foundation Trust, Barts & The London NHS Trust, University Hospitals, Leicester, Nottingham University Hospitals NHS Trust, University Hospitals of North Midlands NHS Trust, Sheffield Teaching Hospitals NHS Foundation Trust, Hull University Teaching Hospitals NHS Trust, The Leeds Teaching Hospitals NHS Trust, Cambridge University Hospitals NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, Portsmouth Hospitals NHS Trust, Oxford University Hospitals NHS Trust, University Hospital Plymouth NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust, Royal Devon and Exeter NHS Foundation Trust, Taunton and Somerset Hospital, Lancashire Teaching Hospitals NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, NHS Greater Glasgow and Clyde
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 26 Aug 2030 (estimated)
- Study completion
- 26 Aug 2030 (estimated)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 1. Referral to a specialist severe asthma clinic in the UK due to inadequate asthma control
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients with no systemic corticosteroid exposure in most recent 12 month follow-up period
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Queen's University, Belfast at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with no systemic corticosteroid exposure in most recent 12 month follow-up period (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.