Clinical trial NCT04200326: Real-life First Dose Effect of Fasenra in Patients With Severe Uncontrolled Asthma
Official title: Real-life First Dose Effect of Fasenra in Patients With Severe Uncontrolled Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Uncontrolled Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-12-16
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. Any detection of an early, subjective first-dose effect in this pilot study will be further validated in a larger follow-up study.

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

Eligibility criteria: 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)

Primary outcomes:
measure: Sentiment score
timeFrame: 6 weeks from baseline
measure: Emotion confidence score
timeFrame: 6 weeks from baseline
measure: Key phrase extraction
timeFrame: 6 weeks from baseline
measure: Message analysis
timeFrame: 6 weeks from baseline
Secondary outcomes:
measure: PEF
timeFrame: 6 weeks
measure: FEV1
timeFrame: 6 weeks
measure: FEV1/FVC
timeFrame: 6 weeks
measure: ACQ-6 Score
timeFrame: 6 weeks
measure: SGRQ Score
timeFrame: 4 weeks from Fasenra injection
measure: daily UMotif measure
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Astra Zeneca R&D
name: Lynn Hagger
role: STUDY_DIRECTOR
References: