Severe Uncontrolled Asthma Clinical Trial
— TWINKLEOfficial title:
Real-life First Dose Effect of Fasenra in Patients With Severe Uncontrolled Asthma
NCT number | NCT04200326 |
Other study ID # | D3250R00061 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 20, 2019 |
Est. completion date | April 9, 2020 |
Verified date | April 2021 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | April 9, 2020 |
Est. primary completion date | April 9, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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). Exclusion Criteria: - 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) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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AstraZeneca |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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. |
6 weeks from baseline | |
Secondary | 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 | |
Secondary | 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. | 6 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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