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

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 Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Biologic treatment

• Study Type: Observational
• Enrollment (Actual): 415

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom
    • Research Site
  • London, United Kingdom
    • Research Site
  • Manchester, United Kingdom
    • Research Site
  • Southampton, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients in clinical remission	Proportion of patients with zero exacerbations, zero mOCS use and ACQ <1.5	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	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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Actual): August 20, 2024
• Study Completion (Actual): August 20, 2024

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: D2287R00189

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.