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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.
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
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| Measure | Description | Time Frame |
|---|---|---|
| Sentiment score | 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). | 6 weeks from baseline |
| Emotion confidence score | 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. | 6 weeks from baseline |
| Key phrase extraction | 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. | 6 weeks from baseline |
| Message analysis | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PEF | Association between any onset of effect seen for PROACT measures and lung function (PEF, Peak Expiratory Flow) measurements. it can either be measured in L/sec or L/min . | 6 weeks |
| FEV1 | Association between any onset of effect seen for PROACT measures and lung function (FEV1, Forced Expiratory Volume in 1 Second) measurements. Measured in liters. |
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Inclusion Criteria:
Exclusion Criteria:
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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) who are beginning Fasenra treatment as standard of care.
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| Name | Affiliation | Role |
|---|---|---|
| Lynn Hagger | Astra Zeneca R&D | Study Director |
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| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| 6 weeks from baseline |
| 6 weeks |
| FEV1/FVC | Association between any onset of effect seen for PROACT measures and lung function (FEV1/FVC (forced vital capacity), ratio of FEV1 to FVC ) measurements. Can be expressed as a percentage or ratio. | 6 weeks |
| ACQ-6 Score | Association between any onset of effect seen for PROACT measures and PRO ACQ-6, using the ACQ-6 score. Patients are asked to recall how their asthma has been during the previous week by responding to 6 questions. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score is the mean of the responses. Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and <1.5 indicate partly controlled asthma, and a score ≥1.5 indicates not well-controlled asthma. | 6 weeks |
| SGRQ Score | Association between any onset of effect seen for PROACT measures and PRO SQRQ, using the SGRQ Score. The SGRQ is a 50-item PRO instrument developed to measure the health status of patients with airway obstruction diseases. The questionnaire is divided into 2 parts: part 1 consists of 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; part 2 consists of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The SGRQ yields a total score and 3 domain scores (symptoms, activity, and impacts). The total score indicates the impact of disease on overall health status. This total score is expressed as a percentage of overall impairment, in which 100 represents the worst possible health status and 0 indicates the best possible health status. Likewise, the domain scores range from 0 to 100, with higher scores indicative of greater impairment. | 4 weeks from Fasenra injection |
| daily UMotif measure | Association between any onset of effect seen in the daily uMotif measures and the ACQ-6 and SQRQ/lung function measurements will be assessed. The UMotif Quality of Life questionnaire consists of 10 separate 5 point Likert scale questions. Of these, 8 are required questions, and the remaining 2 are chosen at enrolment by patients from a choice of 4 possible questions. Responses to each of these questions will be compared to their own baseline at enrolment to derive personalized metrics. A composite metric will also be created by appropriately combining the individual question responses. The required 8 questions will be summarized descriptively by day. The 2 optional questions that patients report daily will be reported descriptively. | 6 weeks |