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

NCT06261567 | Completed

• 1 other identifier: D2287R00189
• Study Type: observational
• Target: 415
• Locations: 1 country
• Sites: 4

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (29)

• 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)

Interventions

Biologic treatment DRUG

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

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients who were involved in any interventional clinical trial during the study period (+/- 12 months from index).

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (4)

Research Site

Birmingham, United Kingdom

Location

Research Site

London, United Kingdom

Location

Research Site

Manchester, United Kingdom

Location

Research Site

Southampton, United Kingdom

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: February 15, 2024
• Study Start: February 27, 2024
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• 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
• 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.

Locations

GB (4)