A Non-interventional, Prospective Study With Benralizumab

Last updated: March 13, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

Asthma

Treatment

N/A

Clinical Study ID

NCT06422078
D3250R00124
  • Ages 18-120
  • All Genders

Study Summary

This is a prospective, non-interventional, single-arm, multicenter study to investigate asthma control, and health-related quality of life (HRQL), lung function and asthma medication intake in severe eosinophilic asthma patients treated with benralizumab in a real-life setting in Germany.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female patients aged 18 years or older

  • Confirmed diagnosis of severe eosinophilic asthma (defined according to the EuropeanRespiratory Society and American Thoracic Society and local German guidelines)treated with high-dose inhaled corticosteroids (ICS) plus long-acting beta agonists (LABA)

  • Prescribed treatment with benralizumab according to label and local marketreimbursement criteria

  • Benralizumab treatment was not part of the study decision and treatment decision wasmet prior and independently of the study

  • Patients must be able and willing to read and comprehend written instructions

  • After full explanation, patients must have signed an informed consent form (ICF)indicating that they understand the purpose of, and the procedures required for thestudy and are willing to participate in the study

  • Patients must be willing to report asthma patient-reported outcomes (PROs) every 4weeks and medication intake weekly

Exclusion

Exclusion Criteria:

  • Patients who participate in an observational trial that might, in the investigators'opinion, influence the assessment for current study; or participated in a randomizedclinical trial in the last 3 months

  • History of anaphylaxis to any biologic therapy

  • Prior treatment with any asthma biologic therapy within the last 6 months

  • Concurrent asthma biologic therapy

  • Helminth parasitic infection diagnosed within 24 weeks prior to the date informedconsent was obtained that had not been treated with, or had failed to respond tostandard of care (SOC) therapy

  • Any other pulmonary disease than asthma that, in the investigator's point of view,would have an impact on the interpretation of results

  • An acute or chronic condition that, in the investigator's point of view, would limitthe patient's ability to complete questionnaires or participate in this study orimpact the interpretations of results

  • Current or history of malignancy within 5 years before the enrolment date with thefollowing exceptions:

  • In-situ carcinoma of the cervix where curative therapy has been completed andpatients are in remission for at least 12 months prior to enrolment date

  • Basal cell or superficial squamous skin cancer

  • Pregnancy or lactation period (status to be proactively asked by the investigator)

  • Any condition, that, in the opinion of the investigator, could jeopardize the safetyof the patient

Study Design

Total Participants: 300
Study Start date:
July 25, 2024
Estimated Completion Date:
December 31, 2026

Study Description

This is a prospective observational study to investigate the asthma control and health realted quality of life (HRQL) of benralizumab treated patients in routine clinical practice, their asthma medication intake, and their changes in asthma medication during the study, up to 52 weeks.

The asthma control will be analyzed by using the Asthma Control Test (ACT) and the Asthma Impairment and Risk Questionnaire (AIRQ®) at different timepoints during the study period either collected by the investigator or self-reported by the patient. In addition, health realted quality of life will be assessed at baseline and routine follow-up visits using the mini Asthma Quality of Life Questionnaire (miniAQLQ) which is collected by the investigator. To investigate the medication intake and assess the changes in asthma medication, the patients will record their weekly medication intake in a paper-based or an electronic medication diary throughout the study.

Connect with a study center

  • Research Site

    Ansbach,
    Germany

    Active - Recruiting

  • Research Site

    Auerbach,
    Germany

    Active - Recruiting

  • Research Site

    Berlin,
    Germany

    Active - Recruiting

  • Research Site

    Cottbus,
    Germany

    Active - Recruiting

  • Research Site

    Darmstadt,
    Germany

    Active - Recruiting

  • Research Site

    Dusseldorf,
    Germany

    Active - Recruiting

  • Research Site

    Ehringshausen,
    Germany

    Active - Recruiting

  • Research Site

    Frankfurt am Main,
    Germany

    Active - Recruiting

  • Research Site

    Hamburg,
    Germany

    Active - Recruiting

  • Research Site

    Heidelberg,
    Germany

    Active - Recruiting

  • Research Site

    Itzehoe,
    Germany

    Active - Recruiting

  • Research Site

    Jena,
    Germany

    Active - Recruiting

  • Research Site

    Leipzig,
    Germany

    Active - Recruiting

  • Research Site

    Lorrach,
    Germany

    Active - Recruiting

  • Research Site

    Lubeck,
    Germany

    Active - Recruiting

  • Research Site

    Markkleeberg,
    Germany

    Active - Recruiting

  • Research Site

    Papenburg,
    Germany

    Active - Recruiting

  • Research Site

    Rostock,
    Germany

    Active - Recruiting

  • Research Site

    Saalfeld,
    Germany

    Active - Recruiting

  • Research Site

    Weissenburg,
    Germany

    Active - Recruiting

  • Research Site

    Wilhelmshaven,
    Germany

    Active - Recruiting

  • Research Site

    Wurzburg,
    Germany

    Active - Recruiting

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