A Non-interventional, Prospective Study With Benralizumab (AIR POWER)

AstraZeneca

Status: Enrolling

Conditions: Asthma, Bronchial

Study type: Observational

Funder types: Industry

Identifiers

NCT06422078

D3250R00124

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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