AzTrials
AzTrials

Asthma, BronchialAIR POWERNCT06422078

A Non-interventional, Prospective Study With Benralizumab

An observational study of Asthma, Bronchial, run by AstraZeneca at 41 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Asthma, Bronchial
How many people
300 participants
Where
41 sitesGermany
Study dates
25 Jul 2024to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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

Who cannot join

  • 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 3 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
Show all 12Show fewer
  • 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

Trial locations and contacts

41 sites in 1 country. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

41 sites in 1 country

Germany41 sites, 40 recruiting
  • Research Site

    Ahrensburg

    Recruiting
  • Research Site

    Ansbach

    Recruiting
  • Research Site

    Aschaffenburg

    Recruiting
  • Research Site

    Auerbach

    Recruiting
  • Research Site

    Augsburg

    Recruiting
  • Research Site

    Bad Homburg

    Recruiting
  • Research Site

    Berlin

    Recruiting
  • Research Site

    Cottbus

    Recruiting
  • Research Site

    Darmstadt

    Recruiting
  • Research Site

    Dresden

    Recruiting
  • Research Site

    Düsseldorf

    Recruiting
  • Research Site

    Ehringshausen

    Recruiting
  • Research Site

    Erkelenz

    Recruiting
  • Research Site

    Essen

    Recruiting
  • Research Site

    Flensburg

    Recruiting
  • Research Site

    Frankfurt am Main

    Recruiting
  • Research Site

    Garmisch-Partenkirchen

    Recruiting
  • Research Site

    Halle

    Recruiting
  • Research Site

    Hamburg

    Recruiting
  • Research Site

    Hanover

    Recruiting
  • Research Site

    Heidelberg

    Withdrawn
  • Research Site

    Heidelberg

    Recruiting
  • Research Site

    Hohenstein-Ernsttahl

    Recruiting
  • Research Site

    Itzehoe

    Recruiting
  • Research Site

    Jena

    Recruiting
  • Research Site

    Leipzig

    Recruiting
  • Research Site

    Loerrach

    Recruiting
  • Research Site

    Lübeck

    Recruiting
  • Research Site

    Lüneburg

    Recruiting
  • Research Site

    Markkleeberg

    Recruiting
  • Research Site

    Mönchengladbach

    Recruiting
  • Research Site

    Neuruppin

    Recruiting
  • Research Site

    Nuremberg

    Recruiting
  • Research Site

    Papenburg

    Recruiting
  • Research Site

    Rostock

    Recruiting
  • Research Site

    Saalfeld

    Recruiting
  • Research Site

    Spardorf

    Recruiting
  • Research Site

    Weißenburg

    Recruiting
  • Research Site

    Wilhelmshaven

    Recruiting
  • Research Site

    Würzburg

    Recruiting
  • Research Site

    Zossen

    Recruiting

Other trials in Germany

About this study

Official title: A Non-interventional, Prospective Study With Benralizumab to Investigate Clinical Outcome Based on Standard of Care Medication in Real-life

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.

Read the 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.

Keywords
benralizumab, severe eosinophilic asthma, quality of life, asthma control
Medical subject headings
Asthma, Pulmonary Eosinophilia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From baseline to week 12, 24 and 52

  2. 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).

    Measured: At baseline, week 12, 24 and 52

  3. 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.

    Measured: From baseline to week 12, 24 and 52

  4. 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.

    Measured: From baseline to week 12, 24 and 52

  5. 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.

    Measured: From baseline to week 52

  6. 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.

    Measured: From baseline to week 52

Secondary outcomes (19)
  1. Proportion of patients meeting any individual criteria for remission at baseline, week 24 and 52 after first benralizumab dose

    To describe the proportion of patients who meet any individual criteria for remission.

    Criteria for remission are defined as no exacerbation, no prescribed use of oral corticosteroids (OCS) for asthma, ACT score ≥20, and stable lung function).

    Measured: At baseline, week 24 and 52

  2. Proportion of patients fulfilling all the criteria for remission at baseline, week 24 and 52 after first benralizumab dose

    To describe the proportion of patients who meet all criteria for remission after initiation of benralizumab treatment.

    Measured: At baseline, week 24 and 52

  3. Total Asthma Impairment and Risk Questionnaire® (AIRQ®) score reduction from baseline to every 4 weeks after first benralizumab dose

    To assess diaries reported asthma control in patients initiating treatment with benralizumab using the AIRQ® score.

    The AIRQ® includes 10 questions (7 assessing symptom impairment and 3 assessing risk) concerning patient medication use, asthma symptoms, medical visits, and tests. The AIRQ® can predict the risk for exacerbations and assess the quality of life of asthma patients.

    AIRQ® score: well-controlled (0-1 points), not well-controlled (2-4 points) and very poorly controlled (≥5 points) asthma

    Measured: From baseline to week 52

  4. Total ACT score reduction from baseline to every 4 weeks after first benralizumab dose

    To assess diaries reported asthma control in patients initiating treatment with benralizumab using the ACT score.

    Measured: From baseline to week 52

  5. Change in total Mini Asthma Quality of Life Questionnaire (miniAQLQ) score from baseline to week 12, 24, and 52 after first benralizumab dose

    To describe patient-reported health-related quality of life (HRQL) in patients initiating treatment with benralizumab using the miniAQLQ.

    The miniAQLQ is composed of 15 questions covering 4 different domains, namely symptoms, activities, emotions, and environment experienced during the previous 2 weeks. The score in each item can vary from 1 to 7, with a higher score indicating better quality of life (QoL). The mean score is calculated as the total score divided by the number of items, and the domain scores are calculated as the total score divided by the number of items for respective domain. A change in score of ≥0.5 can be considered clinically important

    Measured: From baseline to week 12, 24 and 52

  6. Change in daily doses of prescribed relevant background medication from baseline to week 12, 24 and 52 after first benralizumab dose

    To describe the proportion of patients regarding prescribed standard-of-care (SOC) asthma medication dose change in patients initiating treatment with benralizumab.

    Measured: From baseline to week 12, 24 and 52

  7. Proportion of patients with increased daily dose of relevant background medication from baseline to week 12, 24 and 52 after first benralizumab dose

    To describe the proportion of patients regarding prescribed increased SOC asthma medication dose in patients initiating treatment with benralizumab.

    Measured: From baseline to week 12, 24 and 52

  8. Proportion of patients with decreased daily dose of relevant background medication from baseline to week 12, 24 and 52 after first benralizumab dose

    To describe the proportion of patients regarding prescribed decreased SOC asthma medication dose in patients initiating treatment with benralizumab.

    Measured: From baseline to week 12, 24 and 52

  9. Proportion of patients with equal daily dose of relevant background medication from baseline to week 12, 24 and 52 after first benralizumab dose

    To describe the proportion of patients regarding prescribed equal SOC asthma medication dose in patients initiating treatment with benralizumab.

    Measured: From baseline to week 12, 24 and 52

  10. Annualized exacerbation rate assessed at baseline, week 12, 24 and 52 after first benralizumab dose

    To assess the annualized asthma exacerbation rate in patients initiating treatment with benralizumab.

    Measured: From baseline to week 12, 24 and 52

  11. Proportion of patients without exacerbations at baseline, week 12, 24 and 52 after first benralizumab dose

    To describe the proportion of patients without asthma exacerbations in patients initiating treatment with benralizumab.

    Measured: From baseline to week 12, 24 and 52

  12. Level of lung function parameters - forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC) at baseline, week 12, 24 and 52 after first benralizumab dose

    To describe the FEV1 and FVC levels in patients initiating treatment with benralizumab.

    From FEV1 and FVC the Tiffenau-Index will be calculated as follows: FEV1/FVC

    Measured: At baseline, week 12, 24 and 52

  13. Level of lung function parameters - residual volume (RV) at baseline, week 12, 24 and 52 after first benralizumab dose

    To describe the level of RV in patients initiating treatment with benralizumab.

    Measured: At baseline, week 12, 24 and 52

  14. Level of lung function parameters - total lung capacity (TLC) at baseline, week 12, 24 and 52 after first benralizumab dose

    To describe the level of TLC in patients initiating treatment with benralizumab.

    Measured: At baseline, week 12, 24 and 52

  15. Level of lung function parameters - total specific airway resistance (sRtot) at baseline, week 12, 24 and 52 after first benralizumab dose

    To describe the level of sRtot in patients initiating treatment with benralizumab.

    Measured: At baseline, week 12, 24 and 52

  16. Level of diffusing capacity of the lungs for carbon monoxide (DLCO) at baseline, week 12, 24 and 52 after first benralizumab dose

    To describe the level of DLCO in patients initiating treatment with benralizumab.

    Measured: At baseline, week 12, 24 and 52

  17. Level of biomarkers - eosinophils at baseline, week 12, 24 and 52 after first benralizumab dose

    To describe the level of eosinophils in patients initiating treatment with benralizumab.

    Measured in cells per microliter.

    Measured: At baseline, week 12, 24 and 52

  18. Level of biomarkers - total immunglobulin E (IgE) at baseline, week 12, 24 and 52 after first benralizumab dose

    To describe the level of total IgE in patients initiating treatment with benralizumab.

    Total IgE, measured in international units per milliliter (IU/ml).

    Measured: At baseline, week 12, 24 and 52

  19. Level of biomarkers - fractional exhaled nitric oxide (FeNO) at baseline, week 12, 24 and 52 after first benralizumab dose

    To describe the level of FeNO in patients initiating treatment with benralizumab.

    Measured in parts per billion (ppb).

    Measured: At baseline, week 12, 24 and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2024
  2. Study start25 Jul 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06422078
Sponsor's protocol ID
D3250R00124
Acronym
AIR POWER
Status last verified
Aug 2026
First submitted
15 May 2024
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, Bronchial, run by AstraZeneca at 41 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Asthma Control Test (ACT) total score in patients from baseline to week 12, 24 and 52 after first benralizumab dose (time frame: From baseline to week 12, 24 and 52). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in