AsthmaREMISSION UKNCT06261567
A Retrospective Chart Review to Investigate Clinical Remission in Patients With Severe Asthma Treated With Biologics in the United Kingdom National Health Service
An observational study of Asthma, run by AstraZeneca at 4 sites in United Kingdom.
Trial summary
Asthma is a common lung condition that causes occasional breathing difficulties and affects around 5.4 million people in the UK of all ages. Common symptoms can include wheezing when breathing, breathlessness, a tight chest and coughing. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Asthma
- What is being tested?
- Biologic treatment
- How many people
- 415 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 27 Feb 2024to 20 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The source population for this study will be patients who were treated with a biologic for severe asthma in UK NHS centres between October 2021 and September 2022
Who may be able to join
- Initiated on a biologic treatment for SA between 1st October 2021 and 30th September 2022
- Patients who received ≥1 dose of biologic treatment
- Patients aged ≥18 years at index
Who cannot join
- Patients who were involved in any interventional clinical trial during the study period (+/- 12 months from index).
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Research Site
Birmingham
Research Site
London
Research Site
Manchester
Research Site
Southampton
About this study
Asthma is a common lung condition that causes occasional breathing difficulties and affects around 5.4 million people in the UK of all ages. Common symptoms can include wheezing when breathing, breathlessness, a tight chest and coughing. However, these symptoms can get worse and lead to an asthma attack which can be fatal.
There is currently no cure for asthma but there are treatments that can help keep the symptoms under control. The main types of treatment include reliever inhalers used when needed quickly to reverse asthma symptoms for a short time, and preventer inhalers that are used everyday to prevent symptoms for starting. Unfortunately, not all patients are able to control their asthma on these treatments alone. Biologic treatments, also known as monoclonal antibodies, have been introduced to treat certain types of severe asthma over recent years. These specialist treatments use antibodies produced from cells in a laboratory to help reduce inflammation and might offer the possibility of higher levels of disease control including the reduction or absence of symptoms and normal lung function. This higher level of disease control is called remission.
This study aims to understand whether or not remission is possible in patients with severe asthmas treated with biologics in the NHS. This study will take place a 4 specialist asthma centres in the UK and seeks to include retrospective data from approximately 450 adult patients that were treated with biologics as part of routine care between 01 October 2021 and 30 September 2022. Data will be collected directly from medical records and entered into the study database in a pseudonymised format by members of the direct care team ready for analysis.
- Conditions
- Asthma
- Being tested
- Biologic treatment
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologic treatmentDrug
Patients receiving treatment with any biologic treatment for severe asthma which is approved within the UK NHS. These include omalizumab, mepolizumab, reslizumab, benralizumab and/or dupilumab
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients in clinical remission
Proportion of patients with zero exacerbations, zero mOCS use and ACQ <1.5
Measured: 12 months
Number and proportion achieving specific criteria for clinical remission
Number and proportion achieving the following criteria for clinical remission:
- any 1 criterion
- any 2 criteria
- any 3 criteria
- exacerbation AND maintenance oral corticosteroids (mOCS) criteria
- exacerbation, mOCS, AND asthma symptom control criteria
Measured: 12 months
Number and proportion of super-responders
Measured: 12 months
Number and proportion of responders
Measured: 12 months
Number and proportion of non-responders
Measured: 12 months
Secondary outcomes (29)
Age at index
Measured: Index (first dose of biologic)
Sex
Measured: Index (first dose of biologic)
Ethnicity
Measured: Index (first dose of biologic)
Smoking status
Measured: Index (first dose of biologic)
BMI
Measured: Index (first dose of biologic)
IMD quintile
Measured: Index (first dose of biologic)
Comorbidities
Measured: Index (first dose of biologic)
COVID-19 vaccination status
Measured: Index (first dose of biologic)
Fractional Exhaled Nitric Oxide (FeNO)
Measured: Index (first dose of biologic)
Blood eosinophil count (EOS)
Measured: Index (first dose of biologic)
IgE
Measured: Index (first dose of biologic)
ACQ-6
Measured: Index (first dose of biologic)
AQLQ
Measured: Index (first dose of biologic)
lung function (FEV1)
Measured: Index (first dose of biologic)
Rate of exacerbation in prior 12 months
Measured: Index (first dose of biologic)
Asthma treatments at 6 months
Measured: 6 months
Asthma treatments at 12 months
Measured: 12 months
Annualised exacerbation rate (AER)
Measured: 6 months
mOCS use (proportion with 0 mg/day)
Measured: 6 months
ACQ-6 score
Measured: 6 months
AQLQ score
Measured: 6 months
Lung function (FEV-1)
Measured: 6 months
Respiratory infections
Measured: 6 months
Annualised exacerbation rate (AER)
Measured: 12 months
mOCS use (proportion with 0 mg/day)
Measured: 12 months
ACQ-6 score
Measured: 12 months
AQLQ score
Measured: 12 months
Lung function (FEV-1)
Measured: 12 months
Respiratory infections
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start27 Feb 2024
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
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.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261567
- Sponsor's protocol ID
- D2287R00189
- Acronym
- REMISSION UK
- Status last verified
- Aug 2025
- First submitted
- 9 Jan 2024
- Last updated
- 19 Aug 2025
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Chart Review to Investigate Clinical Remission in Patients With Severe Asthma Treated With Biologics in the United Kingdom National Health Service
- ClinicalTrials.gov ID
- NCT06261567
- Acronym / sponsor ID
- REMISSION UK / D2287R00189
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 15 Feb 2024 (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.
Asthma is a common lung condition that causes occasional breathing difficulties and affects around 5.4 million people in the UK of all ages. Common symptoms can include wheezing when breathing, breathlessness, a tight chest and coughing. However, these symptoms can get worse and lead to an asthma attack which can be fatal.
There is currently no cure for asthma but there are treatments that can help keep the symptoms under control. The main types of treatment include reliever inhalers used when needed quickly to reverse asthma symptoms for a short time, and preventer inhalers that are used everyday to prevent symptoms for starting. Unfortunately, not all patients are able to control their asthma on these treatments alone. Biologic treatments, also known as monoclonal antibodies, have been introduced to treat certain types of severe asthma over recent years. These specialist treatments use antibodies produced from cells in a laboratory to help reduce inflammation and might offer the possibility of higher levels of disease control including the reduction or absence of symptoms and normal lung function. This higher level of disease control is called remission.
This study aims to understand whether or not remission is possible in patients with severe asthmas treated with biologics in the NHS. This study will take place a 4 specialist asthma centres in the UK and seeks to include retrospective data from approximately 450 adult patients that were treated with biologics as part of routine care between 01 October 2021 and 30 September 2022. Data will be collected directly from medical records and entered into the study database in a pseudonymised format by members of the direct care team ready for analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The source population for this study will be patients who were treated with a biologic for severe asthma in UK NHS centres between October 2021 and September 2022
Key inclusion criteria (3 listed)
- Initiated on a biologic treatment for SA between 1st October 2021 and 30th September 2022
- Patients who received ≥1 dose of biologic treatment
- Patients aged ≥18 years at index
Key exclusion criteria (1 listed)
- Patients who were involved in any interventional clinical trial during the study period (+/- 12 months from index).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biologic treatmentPatients receiving treatment with any biologic treatment for severe asthma which is approved within the UK NHS. These include omalizumab, mepolizumab, reslizumab, benralizumab and/or dupilumab | Drug | – |
Primary outcome
Proportion of patients in clinical remission
Time frame: 12 months
Proportion of patients with zero exacerbations, zero mOCS use and ACQ <1.5
Number and proportion achieving specific criteria for clinical remission
Time frame: 12 months
Number and proportion achieving the following criteria for clinical remission: * any 1 criterion * any 2 criteria * any 3 criteria * exacerbation AND maintenance oral corticosteroids (mOCS) criteria * exacerbation, mOCS, AND asthma symptom control criteria
Number and proportion of super-responders
Time frame: 12 months
Number and proportion of responders
Time frame: 12 months
Number and proportion of non-responders
Time frame: 12 months
29 secondary outcomes
Age at index
Time frame: Index (first dose of biologic)
Sex
Time frame: Index (first dose of biologic)
Ethnicity
Time frame: Index (first dose of biologic)
Smoking status
Time frame: Index (first dose of biologic)
BMI
Time frame: Index (first dose of biologic)
IMD quintile
Time frame: Index (first dose of biologic)
Comorbidities
Time frame: Index (first dose of biologic)
COVID-19 vaccination status
Time frame: Index (first dose of biologic)
Fractional Exhaled Nitric Oxide (FeNO)
Time frame: Index (first dose of biologic)
Blood eosinophil count (EOS)
Time frame: Index (first dose of biologic)
IgE
Time frame: Index (first dose of biologic)
ACQ-6
Time frame: Index (first dose of biologic)
AQLQ
Time frame: Index (first dose of biologic)
lung function (FEV1)
Time frame: Index (first dose of biologic)
Rate of exacerbation in prior 12 months
Time frame: Index (first dose of biologic)
Asthma treatments at 6 months
Time frame: 6 months
Asthma treatments at 12 months
Time frame: 12 months
Annualised exacerbation rate (AER)
Time frame: 6 months
mOCS use (proportion with 0 mg/day)
Time frame: 6 months
ACQ-6 score
Time frame: 6 months
AQLQ score
Time frame: 6 months
Lung function (FEV-1)
Time frame: 6 months
Respiratory infections
Time frame: 6 months
Annualised exacerbation rate (AER)
Time frame: 12 months
mOCS use (proportion with 0 mg/day)
Time frame: 12 months
ACQ-6 score
Time frame: 12 months
AQLQ score
Time frame: 12 months
Lung function (FEV-1)
Time frame: 12 months
Respiratory infections
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites 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 AstraZeneca at 4 sites 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in clinical remission (time frame: 12 months). The study lists 5 primary outcomes in all. 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 19 Aug 2025.