Real-life First Dose Effect of Fasenra in Patients With Severe Uncontrolled Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 5
- 主要终点
- Emotion confidence score
研究概览
简要总结
This pilot study will use novel technologies to collect information about the patient experience before and early after starting Fasenra (benralizumab) as standard of care for severe uncontrolled asthma in a real-world setting, to determine how the experience changes over time. Any detection of an early, subjective first-dose effect in this pilot study will be further validated in a larger follow-up study.
详细描述
PRIMARY OBJECTIVE: Explore the use of novel technologies to detect early changes in quality of life (QoL) within the first 4 weeks after first dose of Fasenra for the treatment of severe uncontrolled asthma.
ENDPOINTS: Improvement in QoL measures, and physical and mental well-being as assessed by an increase in positive facial expressions, positive keywords, and quality of life biomarkers, with a decrease in asthma symptoms and improvement in FEV1 and PEF within the first 4 weeks after beginning Fasenra.
TARGET POPULATION: Individuals aged 18-75 years with severe asthma uncontrolled (ACQ >=1.5) on current medications (HD-ICS/LABA with/without other maintenance therapies except biologics). Patients beginning Fasenra asstandard of care as specified by NICE guidelines.
STUDY DURATION: The study duration per patient will be approximately 6 weeks from the enrolment visit to end of recorded data. Subjects will record data for 2 weeks prior to their first injection with Fasenra and then for 4 more weeks post-injection. PROCEDURESPatients will be required to visit the study site 3 times (enrolment and onboarding visit, Fasenra injection visit, last visit), and perform daily tasks at home in between site visits
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 18-75 years with severe asthma uncontrolled (ACQ >=1.5) on current medications (HD-ICS/LABA with/without other maintenance therapies except biologics).
- •Patients beginning Fasenra as standard of care as specified by NICE guidelines. That is, patients having either 4 exacerbations in the previous year and an eosinophil count over 300 cells/ microliter OR 3 exacerbations in the previous year and an eosinophil count over 400 cells/ microliter.
- •Provision of informed consent prior to any study specific procedures
- •Patients must have a smartphone that is compatible with the device software (iOS and Android).
- •Availability of, and willingness to use, without reimbursement of any potential additional costs incurred, their computer and/or iOS/Android device for the collection and transmission of information
- •English speaking and reading (ability to understand ICF, patient materials, the study app and to interact with the onboarding agent).
排除标准
- •Patients taking daily prednisolone (or equivalent)
- •Patients currently taking a biologic medication or participating in a clinical study involving a biologic medication for a respiratory illness.
- •Comorbid conditions that cause symptoms similar to those experienced with asthma (e.g./ cough, wheeze, breathlessness, or nighttime awakening).
- •Patients with comorbidities that also significantly affect patient's quality of life and daily functioning as determined by the treating physician.
- •Presence of other chronic pulmonary conditions (e.g./ COPD)
- •Patients that in the opinion of the physician are unlikely to complete 6 weeks of the study (example reasons: digital literacy, unwillingness/inability to interact with apps; historically poor adherence to study procedures)
结局指标
主要结局
Emotion confidence score
时间窗: 6 weeks from baseline
Evaluate if the PROACT system can detect early signs of changes in quality of life (QoL) using emotion confidence score to determine changes in peoples' emotions as a subjective measure of first-dose effects of a medication. Emotion confidence score should be the confidence (probability) of the predicted emotion given by the machine learning model. The scores will be scaled proportionally to have a sum of 1.0 for each frame of the video.
Key phrase extraction
时间窗: 6 weeks from baseline
Evaluate if the PROACT system can detect early signs of changes in quality of life (QoL) using key phrase extraction to determine changes in peoples' emotions as a subjective measure of first-dose effects of a medication. Key phrase extraction is a descriptive summary of the video message recorded.
Message analysis
时间窗: 6 weeks from baseline
Evaluate if the PROACT system can detect early signs of changes in quality of life (QoL) using message analysis to determine changes in peoples' emotions as a subjective measure of first-dose effects of a medication. The message analysis will define: The topic - what it is that the participant is trying to share. This is coded using an evolving, hierarchical, lexicon. The impact - if reported, the impact that this is having on the participant is also coded. An interpreted impact color scale (green-amber-red) is also applied by the analysts to aid quick identification of the most, and least, impactful things. The outcome - if reported, what the person did as a result of what happened. This is also coded so that it can also be aggregated across patients.
Sentiment score
时间窗: 6 weeks from baseline
Evaluate if the PROACT system can detect early signs of changes in quality of life (QoL) using sentiment analysis to determine changes in peoples' emotions as a subjective measure of first-dose effects of a medication. the score should be the positivity of the expression, scaled from 0 (the most negative) to 1.0 (totally positive).
次要结局
- FEV1(6 weeks)
- PEF(6 weeks)
- FEV1/FVC(6 weeks)
- ACQ-6 Score(6 weeks)
- SGRQ Score(4 weeks from Fasenra injection)
- daily UMotif measure(6 weeks)