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NCT06422078 | RECRUITING | Asthma, Bronchial

A Non-interventional, Prospective Study With Benralizumab
Sponsor:

AstraZeneca

Brief 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.

Condition or disease

Asthma, Bronchial

Detailed 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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 300 participants
Official Title : A Non-interventional, Prospective Study With Benralizumab to Investigate Clinical Outcome Based on Standard of Care Medication in Real-life
Actual Study Start Date : 2024-07-25
Estimated Primary Completion Date : 2027-07-31
Estimated Study Completion Date : 2027-07-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 120 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Male or female patients aged 18 years or older
  • * Confirmed diagnosis of severe eosinophilic asthma (defined according to the European Respiratory 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 market reimbursement criteria
  • * Benralizumab treatment was not part of the study decision and treatment decision was met 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 the study and are willing to participate in the study
  • * Patients must be willing to report asthma patient-reported outcomes (PROs) every 4 weeks and medication intake weekly
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 randomized clinical 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 informed consent was obtained that had not been treated with, or had failed to respond to standard 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 limit the patient's ability to complete questionnaires or participate in this study or impact the interpretations of results
  • * Current or history of malignancy within 5 years before the enrolment date with the following exceptions
    • * In-situ carcinoma of the cervix where curative therapy has been completed and patients 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 safety of the patient
A Non-interventional, Prospective Study With Benralizumab

Location Details

NCT06422078

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Germany,

Research Site

Ahrensburg, Germany,

RECRUITING

Germany,

Research Site

Ansbach, Germany,

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Germany,

Research Site

Auerbach, Germany,

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Germany,

Research Site

Bad Homburg, Germany,

RECRUITING

Germany,

Research Site

Berlin, Germany,

RECRUITING

Germany,

Research Site

Cottbus, Germany,

RECRUITING

Germany,

Research Site

Darmstadt, Germany,

RECRUITING

Germany,

Research Site

Düsseldorf, Germany,

RECRUITING

Germany,

Research Site

Ehringshausen, Germany,

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Germany,

Research Site

Essen, Germany,

RECRUITING

Germany,

Research Site

Flensburg, Germany,

RECRUITING

Germany,

Research Site

Frankfurt am Main, Germany,

RECRUITING

Germany,

Research Site

Halle, Germany,

RECRUITING

Germany,

Research Site

Hamburg, Germany,

RECRUITING

Germany,

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Hanover, Germany,

RECRUITING

Germany,

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Heidelberg, Germany,

RECRUITING

Germany,

Research Site

Hohenstein-Ernstthal, Germany,

RECRUITING

Germany,

Research Site

Itzehoe, Germany,

RECRUITING

Germany,

Research Site

Jena, Germany,

RECRUITING

Germany,

Research Site

Leipzig, Germany,

RECRUITING

Germany,

Research Site

Loreg, Germany,

RECRUITING

Germany,

Research Site

Lübeck, Germany,

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Germany,

Research Site

Lüneburg, Germany,

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Germany,

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Markkleeberg, Germany,

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Germany,

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Neuruppin, Germany,

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Germany,

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Nuremberg, Germany,

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Germany,

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Papenburg, Germany,

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Germany,

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Rostock, Germany,

RECRUITING

Germany,

Research Site

Saalfeld, Germany,

RECRUITING

Germany,

Research Site

Spardorf, Germany,

RECRUITING

Germany,

Research Site

Weißenburg, Germany,

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Germany,

Research Site

Wilhelmshaven, Germany,

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Germany,

Research Site

Würzburg, Germany,

RECRUITING

Germany,

Research Site

Zossen, Germany,