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

NCT ID: NCT06261567

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

415 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-27

Study Completion Date

2024-08-20

Brief Summary

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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

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Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Biologic treatment

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

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Birmingham, , United Kingdom

Site Status

Research Site

London, , United Kingdom

Site Status

Research Site

Manchester, , United Kingdom

Site Status

Research Site

Southampton, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D2287R00189

Identifier Type: -

Identifier Source: org_study_id

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