NCT04184284已完成不适用
imPROve-asthma - A Prospective, 24-month, Observational Study to Investigate the Change in Patient-Reported Outcomes in Severe Eosinophilic Asthma Patients Treated With Benralizumab Biologic Therapy Under Real-life Conditions in Germany
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- The change in asthma control after 6 months of treatment in anti-IL5/IL5R naïve patients initiated with benralizumab treatment
研究概览
简要总结
The main aim of this study is to investigate the change in asthma control after 6 months of therapy in patients treated with benralizumab biologic therapy for severe eosinophilic asthma under real-life conditions in a pulmonary care setting in Germany. The study also aims to investigate Quality-of-Life (QoL), the early treatment response, treatment effectiveness and the change in asthma control over time, following benralizumab therapy. This study will also describe the physician-chosen reasons for starting beralizumab therapy or switching to benralizumab therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 18 years or older with confirmed diagnosis of severe asthma according to the ATS/ERS and local German guidelines
- •Decision was made by the investigator (regardless of this NIS) to start treating the patient with benralizumab according to severe eosinophilic asthma indication (NB: can include patients that are switched from another EU approved biologic treatment if required for a medical reason).
- •Patients must be able and willing to read and comprehend written instructions, and comprehend and complete the questionnaires required by the protocol
- •After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study.
排除标准
- •Concomitant treatment with any other biologic for any indication
- •Patients already treated with benralizumab
- •Clinically important pulmonary disease other than asthma including: chronic obstructive pulmonary disease (as main diagnosis), bronchiectasis, idiopathic pulmonary fibrosis, pulmonary hypertension, alpha-1-antitrypsin-deficiency, and malignancy of any kind (NB: the following conditions are permitted: nasal polyposis, allergic rhinitis, atopic dermatitis, non-idiopathic pulmonary fibrosis).
- •An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to complete questionnaires or participate in this study or impact the interpretations of results.
- •Concurrent biologics for asthma are not allowed except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment). Acceptable wash-out periods for other asthma biologics: ≥30 days from last dose of previous biologic
- •Pregnancy or lactation period
- •Participation in an observational trial that might, in the investigator's opinion, influence the assessment for the current study, or participation in a randomized clinical trial in the last 3 months
结局指标
主要结局
The change in asthma control after 6 months of treatment in anti-IL5/IL5R naïve patients initiated with benralizumab treatment
时间窗: Baseline and 6 months after baseline
Change from baseline in (Asthma Control Test - questionnaire) ACT score after 6 months treatment in anti-IL5/IL5R naïve patients. ACT is a simple, validated, 5-item tool giving a total score from 5 (worst control) to 25 (best control). Scores of 20 to 25 denote well-controlled asthma, scores ≤19 identifies patients with poorly controlled asthma. The minimum clinically important difference (MCID) is reported to be 3 points.
次要结局
- The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 14, VAS-2(Baseline and day 14 after first treatment)
- The investigator reported treatment effectiveness after 6 months of treatment in anti-IL5/IL5R naïve patients initiated with benralizumab treatment(6 months after first treatment)
- The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 7, VAS-2(Baseline and day 7 after first treatment)
- The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 14, ACQ-6(Baseline and day 14 after first treatment)
- The change of asthma control over time and the maintained response after initiation of benralizumab treatment in anti-IL5/IL5R naïve patients initiated with benralizumab treatment using ACQ-6(Date of enrollment until end of follow-up (approx. 24 months after enrollment))
- The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 7, ACQ-6(Baseline and day 7 after first treatment)
- The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 7, VAS-1(Baseline and day 7 after first treatment)
- The change in health-related quality of life (HRQL) in anti-IL5/IL5R naïve patients initiated with benralizumab treatment(Baseline and 6 months after first treatment)
- The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 14, VAS-1(Baseline and day 14 after first treatment)
- The change of asthma control over time and the maintained response after initiation of benralizumab treatment in anti-IL5/IL5R naïve patients initiated with benralizumab treatment using ACT(Date of enrollment until end of follow-up (approx. 24 months after enrollment))
- The reasons for biologic treatment change(Date of enrollment until end of follow-up (approx. 24 months after enrollment))
研究者
研究点 (1)
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