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Severe Uncontrolled AsthmaTWINKLENCT04200326

Real-life First Dose Effect of Fasenra in Patients With Severe Uncontrolled Asthma

An observational study of Severe Uncontrolled Asthma, run by AstraZeneca.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Severe Uncontrolled Asthma
How many people
5 participants
Where
No sites listed yet
Study dates
20 Dec 2019to 9 Apr 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study 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) who are beginning Fasenra treatment as standard of care.

Who may be able to join

  • 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).

Who cannot join

  • 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)

About this study

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.

Read the detailed description

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 6 weeks from baseline

  2. 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.

    Measured: 6 weeks from baseline

  3. 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.

    Measured: 6 weeks from baseline

  4. 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.

    Measured: 6 weeks from baseline

Secondary outcomes (6)

  1. 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 .

    Measured: 6 weeks

  2. 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.

    Measured: 6 weeks

  3. 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.

    Measured: 6 weeks

  4. 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.

    Measured: 6 weeks

  5. 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.

    Measured: 4 weeks from Fasenra injection

  6. 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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2019
  2. Study start20 Dec 2019
  3. Primary completion9 Apr 2020
  4. Study completion9 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04200326
Sponsor's protocol ID
D3250R00061
Acronym
TWINKLE
Status last verified
Apr 2021
First submitted
5 Nov 2019
Last updated
8 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Uncontrolled Asthma, run by AstraZeneca.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sentiment score (time frame: 6 weeks from baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04200326.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.

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