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

Recruiting

• Conditions: Asthma

• Registration Number: NCT06261567
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-09
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-15
• Study Start: 2024-02-27
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12
• Primary Completion: 2024-09-27
• Study Completion: 2024-09-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 425

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number and proportion of responders	12 months
Number and proportion achieving specific criteria for clinical remission	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 non-responders	12 months
Proportion of patients in clinical remission	12 months	Proportion of patients with zero exacerbations, zero mOCS use and ACQ \<1.5
Number and proportion of super-responders	12 months

Secondary Outcome Measures

Name	Time	Method
IMD quintile	Index (first dose of biologic)
Sex	Index (first dose of biologic)
Smoking status	Index (first dose of biologic)
Comorbidities	Index (first dose of biologic)
ACQ-6	Index (first dose of biologic)
AQLQ	Index (first dose of biologic)
Rate of exacerbation in prior 12 months	Index (first dose of biologic)
Age at index	Index (first dose of biologic)
Ethnicity	Index (first dose of biologic)
BMI	Index (first dose of biologic)
Annualised exacerbation rate (AER)	12 months
mOCS use (proportion with 0 mg/day)	12 months
COVID-19 vaccination status	Index (first dose of biologic)
Blood eosinophil count (EOS)	Index (first dose of biologic)
lung function (FEV1)	Index (first dose of biologic)
ACQ-6 score	12 months
Fractional Exhaled Nitric Oxide (FeNO)	Index (first dose of biologic)
IgE	Index (first dose of biologic)
Asthma treatments at 6 months	6 months
Asthma treatments at 12 months	12 months
Lung function (FEV-1)	12 months
AQLQ score	12 months
Respiratory infections	12 months

Trial Locations

Locations (1)

Research Site; 🇬🇧 Southampton, United Kingdom