Clinical trial

A Retrospective Chart Review to Investigate Clinical Remission in Patients With Severe Asthma Treated With Biologics in the United Kingdom National Health Service

Name
D2287R00189
Description
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.
Trial arms
Trial start
2024-02-27
Estimated PCD
2024-09-27
Trial end
2024-09-27
Status
Recruiting
Treatment
Biologic treatment
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
Size
425
Primary endpoint
Proportion of patients in clinical remission
12 months
Number and proportion achieving specific criteria for clinical remission
12 months
Number and proportion of super-responders
12 months
Number and proportion of responders
12 months
Number and proportion of non-responders
12 months
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Patients who were involved in any interventional clinical trial during the study period (+/- 12 months from index).
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 425, 'type': 'ESTIMATED'}}
Updated at
2024-05-21

1 organization

1 product

1 indication

Organization
AstraZeneca
Indication
Asthma