A Non-interventional, Prospective Study With Benralizumab
AIR POWER
1 other identifier
observational
300
1 country
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2024
Typical duration for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2024
CompletedFirst Posted
Study publicly available on registry
May 20, 2024
CompletedStudy Start
First participant enrolled
July 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
April 13, 2026
April 1, 2026
3 years
May 15, 2024
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Change in Asthma Control Test (ACT) total score in patients from baseline to week 12, 24 and 52 after first benralizumab dose
To assess asthma control in patients initiating treatment with benralizumab over time. The ACT includes 5 questions. The score can range from 5 (worst control) to 25 (best control). Scores between 20 and 25 indicate well-controlled asthma, and scores lower than 20 indicate patients with not-well controlled asthma.
From baseline to week 12, 24 and 52
Proportion of responders at baseline, week 12, 24 and 52 after first benralizumab dose, using ACT
To assess asthma control in patients initiating treatment with benralizumab. Responders are defined as patients with well-controlled asthma (ACT score ≥20).
At baseline, week 12, 24 and 52
Change in daily doses of prescribed inhaled corticosteroids (ICS) intake from baseline to week 12, 24 and 52 after first benralizumab dose
To assess prescribed daily ICS dose of benralizumab treated patients over time. Doses of medication will be converted to equivalents to be able to make comparisons.
From baseline to week 12, 24 and 52
Change in daily doses of patient-reported inhaled corticosteroids (ICS) intake from baseline to week 12, 24 and 52 after first benralizumab dose
To assess patient-reported daily ICS dose of benralizumab treated patients over time. Doses of medication will be converted to equivalents to be able to make comparisons.
From baseline to week 12, 24 and 52
Reduction (in percentage) in prescribed daily ICS dose intake from baseline to week 52 after first benralizumab dose
To assess prescribed daily ICS dose of benralizumab treated patients with ICS dose reduction.
From baseline to week 52
Reduction (in percentage) in patient-reported daily ICS dose intake from baseline to week 52 after first benralizumab dose
To assess patient-reported daily ICS dose of benralizumab treated patients with ICS dose reduction.
From baseline to week 52
Secondary Outcomes (19)
Proportion of patients meeting any individual criteria for remission at baseline, week 24 and 52 after first benralizumab dose
At baseline, week 24 and 52
Proportion of patients fulfilling all the criteria for remission at baseline, week 24 and 52 after first benralizumab dose
At baseline, week 24 and 52
Total Asthma Impairment and Risk Questionnaire® (AIRQ®) score reduction from baseline to every 4 weeks after first benralizumab dose
From baseline to week 52
Total ACT score reduction from baseline to every 4 weeks after first benralizumab dose
From baseline to week 52
Change in total Mini Asthma Quality of Life Questionnaire (miniAQLQ) score from baseline to week 12, 24, and 52 after first benralizumab dose
From baseline to week 12, 24 and 52
- +14 more secondary outcomes
Eligibility Criteria
The study population will consist of adult patients, who were diagnosed with severe eosinophilic asthma treated by pulmonary specialists, for whom the indication to start benralizumab therapy was received independently of study participation.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (41)
Research Site
Ahrensburg, Germany
Research Site
Ansbach, Germany
Research Site
Aschaffenburg, Germany
Research Site
Auerbach, Germany
Research Site
Augsburg, Germany
Research Site
Bad Homburg, Germany
Research Site
Berlin, Germany
Research Site
Cottbus, Germany
Research Site
Darmstadt, Germany
Research Site
Dresden, Germany
Research Site
Düsseldorf, Germany
Research Site
Ehringshausen, Germany
Research Site
Erkelenz, Germany
Research Site
Essen, Germany
Research Site
Flensburg, Germany
Research Site
Frankfurt am Main, Germany
Research Site
Garmisch-Partenkirchen, Germany
Research Site
Halle, Germany
Research Site
Hamburg, Germany
Research Site
Hanover, Germany
Research Site
Heidelberg, Germany
Research Site
Heidelberg, Germany
Research Site
Hohenstein-Ernsttahl, Germany
Research Site
Itzehoe, Germany
Research Site
Jena, Germany
Research Site
Leipzig, Germany
Research Site
Loerrach, Germany
Research Site
Lübeck, Germany
Research Site
Lüneburg, Germany
Research Site
Markkleeberg, Germany
Research Site
Mönchengladbach, Germany
Research Site
Neuruppin, Germany
Research Site
Nuremberg, Germany
Research Site
Papenburg, Germany
Research Site
Rostock, Germany
Research Site
Saalfeld, Germany
Research Site
Spardorf, Germany
Research Site
Weißenburg, Germany
Research Site
Wilhelmshaven, Germany
Research Site
Würzburg, Germany
Research Site
Zossen, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2024
First Posted
May 20, 2024
Study Start
July 25, 2024
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma 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 deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.