A Non-interventional, Prospective Study With Benralizumab

Official title

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

Overview

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.

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.

Primary outcome measures

• 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]
• Proportion of responders at baseline, week 12, 24 and 52 after first benralizumab dose, using ACT [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: From baseline to week 52]
• Reduction (in percentage) in patient-reported daily ICS dose intake from baseline to week 52 after first benralizumab dose [Time frame: From baseline to week 52]

Secondary outcome measures (12)

• Proportion of patients meeting any individual criteria for remission at baseline, week 24 and 52 after first benralizumab dose [Time frame: 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 [Time frame: 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 [Time frame: From baseline to week 52]
• Total ACT score reduction from baseline to every 4 weeks after first benralizumab dose [Time frame: 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 [Time frame: From baseline to week 12, 24 and 52]
• Change in daily doses of prescribed relevant background medication from baseline to week 12, 24 and 52 after first benralizumab dose [Time frame: From baseline to week 12, 24 and 52]
• Proportion of patients with increased daily dose of relevant background medication from baseline to week 12, 24 and 52 after first benralizumab dose [Time frame: From baseline to week 12, 24 and 52]
• Proportion of patients with decreased daily dose of relevant background medication from baseline to week 12, 24 and 52 after first benralizumab dose [Time frame: From baseline to week 12, 24 and 52]
• Proportion of patients with equal daily dose of relevant background medication from baseline to week 12, 24 and 52 after first benralizumab dose [Time frame: From baseline to week 12, 24 and 52]
• Annualized exacerbation rate assessed at baseline, week 12, 24 and 52 after first benralizumab dose [Time frame: From baseline to week 12, 24 and 52]
• Proportion of patients without exacerbations at baseline, week 12, 24 and 52 after first benralizumab dose [Time frame: From baseline to week 12, 24 and 52]
• 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 [Time frame: At baseline, week 12, 24 and 52]

Eligibility 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 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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Germany · 41 centers

• Research Site — Ahrensburg
• Research Site — Ansbach
• Research Site — Aschaffenburg
• Research Site — Auerbach
• Research Site — Augsburg
• Research Site — Bad Homburg
• Research Site — Berlin
• Research Site — Cottbus
• … and 33 more centers

Identifiers

NCT: NCT06422078 · D3250R00124

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗