Clinical trial NCT06261567: A Retrospective Chart Review to Investigate Clinical Remission in Patients With Severe Asthma Treated With Biologics in the United Kingdom National Health Service
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-02-15
Enrollment: 415
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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.


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).

Primary outcomes:
measure: Proportion of patients in clinical remission
timeFrame: 12 months
measure: Number and proportion achieving specific criteria for clinical remission
timeFrame: 12 months
measure: Number and proportion of super-responders
timeFrame: 12 months
measure: Number and proportion of responders
timeFrame: 12 months
measure: Number and proportion of non-responders
timeFrame: 12 months
Secondary outcomes:
measure: Age at index
timeFrame: Index (first dose of biologic)
measure: Sex
timeFrame: Index (first dose of biologic)
measure: Ethnicity
timeFrame: Index (first dose of biologic)
measure: Smoking status
timeFrame: Index (first dose of biologic)
measure: BMI
timeFrame: Index (first dose of biologic)
measure: IMD quintile
timeFrame: Index (first dose of biologic)
measure: Comorbidities
timeFrame: Index (first dose of biologic)
measure: COVID-19 vaccination status
timeFrame: Index (first dose of biologic)
measure: Fractional Exhaled Nitric Oxide (FeNO)
timeFrame: Index (first dose of biologic)
measure: Blood eosinophil count (EOS)
timeFrame: Index (first dose of biologic)
measure: IgE
timeFrame: Index (first dose of biologic)
measure: ACQ-6
timeFrame: Index (first dose of biologic)
measure: AQLQ
timeFrame: Index (first dose of biologic)
measure: lung function (FEV1)
timeFrame: Index (first dose of biologic)
measure: Rate of exacerbation in prior 12 months
timeFrame: Index (first dose of biologic)
measure: Asthma treatments at 6 months
timeFrame: 6 months
measure: Asthma treatments at 12 months
timeFrame: 12 months
measure: Annualised exacerbation rate (AER)
timeFrame: 6 months
measure: mOCS use (proportion with 0 mg/day)
timeFrame: 6 months
measure: ACQ-6 score
timeFrame: 6 months
measure: AQLQ score
timeFrame: 6 months
measure: Lung function (FEV-1)
timeFrame: 6 months
measure: Respiratory infections
timeFrame: 6 months
measure: Annualised exacerbation rate (AER)
timeFrame: 12 months
measure: mOCS use (proportion with 0 mg/day)
timeFrame: 12 months
measure: ACQ-6 score
timeFrame: 12 months
measure: AQLQ score
timeFrame: 12 months
measure: Lung function (FEV-1)
timeFrame: 12 months
measure: Respiratory infections
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Southampton
country: United Kingdom
facility: Research Site
Study officials:
References: