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OpenTrials
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NCT Number: NCT06261567

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

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.

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Key information

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Birmingham, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

  1. Proportion of patients in clinical remission

    Time frame: 12 months

    Proportion of patients with zero exacerbations, zero mOCS use and ACQ <1.5

  2. Number and proportion achieving specific criteria for clinical remission

    Time frame: 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
  3. Number and proportion of super-responders

    Time frame: 12 months

  4. Number and proportion of responders

    Time frame: 12 months

  5. Number and proportion of non-responders

    Time frame: 12 months

Secondary outcomes

  1. Age at index

    Time frame: Index (first dose of biologic)

  2. Sex

    Time frame: Index (first dose of biologic)

  3. Ethnicity

    Time frame: Index (first dose of biologic)

  4. Smoking status

    Time frame: Index (first dose of biologic)

  5. BMI

    Time frame: Index (first dose of biologic)

  6. IMD quintile

    Time frame: Index (first dose of biologic)

  7. Comorbidities

    Time frame: Index (first dose of biologic)

  8. COVID-19 vaccination status

    Time frame: Index (first dose of biologic)

  9. Fractional Exhaled Nitric Oxide (FeNO)

    Time frame: Index (first dose of biologic)

  10. Blood eosinophil count (EOS)

    Time frame: Index (first dose of biologic)

  11. IgE

    Time frame: Index (first dose of biologic)

  12. ACQ-6

    Time frame: Index (first dose of biologic)

  13. AQLQ

    Time frame: Index (first dose of biologic)

  14. lung function (FEV1)

    Time frame: Index (first dose of biologic)

  15. Rate of exacerbation in prior 12 months

    Time frame: Index (first dose of biologic)

  16. Asthma treatments at 6 months

    Time frame: 6 months

  17. Asthma treatments at 12 months

    Time frame: 12 months

  18. Annualised exacerbation rate (AER)

    Time frame: 6 months

  19. mOCS use (proportion with 0 mg/day)

    Time frame: 6 months

  20. ACQ-6 score

    Time frame: 6 months

  21. AQLQ score

    Time frame: 6 months

  22. Lung function (FEV-1)

    Time frame: 6 months

  23. Respiratory infections

    Time frame: 6 months

  24. Annualised exacerbation rate (AER)

    Time frame: 12 months

  25. mOCS use (proportion with 0 mg/day)

    Time frame: 12 months

  26. ACQ-6 score

    Time frame: 12 months

  27. AQLQ score

    Time frame: 12 months

  28. Lung function (FEV-1)

    Time frame: 12 months

  29. Respiratory infections

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: REMISSION UK

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 15, 2024
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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