A Non-interventional, Prospective Study With Benralizumab to Investigate Clinical Outcome Based on Standard of Care Medication in Real-life
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Asthma, Bronchial
- 发起方
- AstraZeneca
- 入组人数
- 300
- 试验地点
- 42
- 主要终点
- Change in Asthma Control Test (ACT) total score in patients from baseline to week 12, 24 and 52 after first benralizumab dose
- 状态
- 招募中
- 最后更新
- 19天前
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Asthma Control Test (ACT) total score in patients from baseline to week 12, 24 and 52 after first benralizumab dose
时间窗: From baseline to week 12, 24 and 52
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.
Proportion of responders at baseline, week 12, 24 and 52 after first benralizumab dose, using ACT
时间窗: At baseline, week 12, 24 and 52
To assess asthma control in patients initiating treatment with benralizumab. Responders are defined as patients with well-controlled asthma (ACT score ≥20).
Change in daily doses of prescribed inhaled corticosteroids (ICS) intake from baseline to week 12, 24 and 52 after first benralizumab dose
时间窗: From baseline to week 12, 24 and 52
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.
Reduction (in percentage) in patient-reported daily ICS dose intake from baseline to week 52 after first benralizumab dose
时间窗: From baseline to week 52
To assess patient-reported daily ICS dose of benralizumab treated patients with ICS dose reduction.
Change in daily doses of patient-reported inhaled corticosteroids (ICS) intake from baseline to week 12, 24 and 52 after first benralizumab dose
时间窗: From baseline to week 12, 24 and 52
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.
Reduction (in percentage) in prescribed daily ICS dose intake from baseline to week 52 after first benralizumab dose
时间窗: From baseline to week 52
To assess prescribed daily ICS dose of benralizumab treated patients with ICS dose reduction.
次要结局
- Total ACT score reduction from baseline to every 4 weeks after first benralizumab dose(From baseline to week 52)
- Proportion of patients without exacerbations at baseline, week 12, 24 and 52 after first benralizumab dose(From baseline to week 12, 24 and 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)
- Annualized exacerbation rate assessed at baseline, week 12, 24 and 52 after first benralizumab dose(From baseline to week 12, 24 and 52)
- Level of lung function parameters - total specific airway resistance (sRtot) at baseline, week 12, 24 and 52 after first benralizumab dose(At baseline, week 12, 24 and 52)
- 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)
- Proportion of patients with increased daily dose of relevant background medication from baseline to week 12, 24 and 52 after first benralizumab dose(From baseline to week 12, 24 and 52)
- Level of lung function parameters - total lung capacity (TLC) at baseline, week 12, 24 and 52 after first benralizumab dose(At baseline, week 12, 24 and 52)
- Level of diffusing capacity of the lungs for carbon monoxide (DLCO) at baseline, week 12, 24 and 52 after first benralizumab dose(At baseline, week 12, 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)
- Change in daily doses of prescribed relevant background medication from baseline to week 12, 24 and 52 after first benralizumab dose(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(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(From baseline to week 12, 24 and 52)
- Level of lung function parameters - residual volume (RV) at baseline, week 12, 24 and 52 after first benralizumab dose(At baseline, week 12, 24 and 52)
- Level of biomarkers - fractional exhaled nitric oxide (FeNO) at baseline, week 12, 24 and 52 after first benralizumab dose(At baseline, 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(At baseline, week 12, 24 and 52)
- Level of biomarkers - eosinophils at baseline, week 12, 24 and 52 after first benralizumab dose(At baseline, week 12, 24 and 52)
- Level of biomarkers - total immunglobulin E (IgE) at baseline, week 12, 24 and 52 after first benralizumab dose(At baseline, week 12, 24 and 52)