protocolSection identificationModule nctId: NCT06261567, orgStudyIdInfo id: D2287R00189, briefTitle: A Retrospective Chart Review to Investigate Clinical Remission in Patients With Severe Asthma Treated With Biologics in the United Kingdom National Health Service, acronym: REMISSION UK, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2024-09-27, completionDateStruct date: 2024-09-27, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Asthma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 425, type: ESTIMATED, armsInterventionsModule interventions name: Biologic treatment, outcomesModule primaryOutcomes measure: Proportion of patients in clinical remission, primaryOutcomes measure: Number and proportion achieving specific criteria for clinical remission, primaryOutcomes measure: Number and proportion of super-responders, primaryOutcomes measure: Number and proportion of responders, primaryOutcomes measure: Number and proportion of non-responders, secondaryOutcomes measure: Age at index, secondaryOutcomes measure: Sex, secondaryOutcomes measure: Ethnicity, secondaryOutcomes measure: Smoking status, secondaryOutcomes measure: BMI, secondaryOutcomes measure: IMD quintile, secondaryOutcomes measure: Comorbidities, secondaryOutcomes measure: COVID-19 vaccination status, secondaryOutcomes measure: Fractional Exhaled Nitric Oxide (FeNO), secondaryOutcomes measure: Blood eosinophil count (EOS), secondaryOutcomes measure: IgE, secondaryOutcomes measure: ACQ-6, secondaryOutcomes measure: AQLQ, secondaryOutcomes measure: lung function (FEV1), secondaryOutcomes measure: Rate of exacerbation in prior 12 months, secondaryOutcomes measure: Asthma treatments at 6 months, secondaryOutcomes measure: Asthma treatments at 12 months, secondaryOutcomes measure: Annualised exacerbation rate (AER), secondaryOutcomes measure: mOCS use (proportion with 0 mg/day), secondaryOutcomes measure: ACQ-6 score, secondaryOutcomes measure: AQLQ score, secondaryOutcomes measure: Lung function (FEV-1), secondaryOutcomes measure: Respiratory infections, secondaryOutcomes measure: Annualised exacerbation rate (AER), secondaryOutcomes measure: mOCS use (proportion with 0 mg/day), secondaryOutcomes measure: ACQ-6 score, secondaryOutcomes measure: AQLQ score, secondaryOutcomes measure: Lung function (FEV-1), secondaryOutcomes measure: Respiratory infections, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 130 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, status: NOT_YET_RECRUITING, city: Birmingham, country: United Kingdom, geoPoint lat: 52.48142, lon: -1.89983, locations facility: Research Site, status: RECRUITING, city: London, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Manchester, country: United Kingdom, geoPoint lat: 53.48095, lon: -2.23743, locations facility: Research Site, status: RECRUITING, city: Southampton, country: United Kingdom, geoPoint lat: 50.90395, lon: -1.40428, hasResults: False