The goal of this pilot clinical trial is to learn whether it is feasible to conduct a future larger trial of a comprehensive management strategy for adults with severe asthma who are starting biologic therapy.
The main questions this pilot study aims to answer are:
Can eligible participants be recruited and retained in the study? Can the study visits, tests, and other study procedures be successfully completed? Is the comprehensive management strategy acceptable to participants and clinicians? What proportion of participants receiving usual asthma care achieve asthma remission at 12 months?
Researchers will compare usual severe asthma care with a comprehensive management approach that uses specialized tests of airway inflammation and lung abnormalities to help doctors make treatment decisions.
Participants will be followed for 12 months. They will complete questionnaires, lung function tests, blood tests, and sputum testing. Clinically available CT scans obtained as part of usual care may also be used for study assessments. Participants may also choose to undergo optional research MRI scans.
Patient understands study procedures and is will to participate in the study as indicated by the patient's signature.
Provision of written, informed consent prior to any study specific procedures.
Males and females ≥ 18 years of age.
Diagnosis of severe asthma, as defined by ATS/ERS guidelines (requiring high-dose ICS plus second controller and/or OCS, or uncontrolled despite this therapy).
Primary respiratory diagnoses other than asthma (e.g., COPD, bronchiectasis) that would meaningfully affect study endpoints per discretion of clinical team.
Patients with incomplete medical records.
Patients who are already in a state of asthma remission.
Patients with contraindications to PFT, sputum induction, CT imaging.
Parallel
Comprehensive Biomarker-Guided Management Strategy
Other interventionParticipants will receive asthma management according to routine clinical practice in addition to a comprehensive biomarker-guided management strategy. Specialized biomarker assessments, including sputum cell analysis and imaging biomarkers, will be made available to the treating clinician and may be incorporated into clinical decision-making regarding asthma management. Treatment decisions may be informed by these specialized biomarker results throughout the 12-month study period.
Standard of Care
Other interventionParticipants will receive asthma management according to routine clinical practice. Specialized biomarker assessments will be performed, but the results will not be disclosed to the treating clinician and will not be used to guide treatment decisions. Treatment decisions will be based on routinely available clinical information and standard clinical practice.
Eligibility Rate
Percentage of individuals screened for the study who meet the study eligibility criteria. The eligibility rate will be calculated as the number of screened individuals who meet the eligibility criteria divided by the total number of individuals screened, multiplied by 100
Recruitment Rate
The recruitment rate will be calculated as the number of participants enrolled divided by the duration of the recruitment period.
Enrolment Rate
The enrolment rate will be calculated as the number of eligible individuals enrolled divided by the total number of eligible individuals approached for participation, multiplied by 100.
Retention Rate
The retention rate will be calculated as the number of participants who complete the Month 12 follow-up divided by the total number of randomized participants, multiplied by 100.
Study Assessment Completion Rate
Percentage of scheduled study assessments completed by participants. The assessment completion rate will be calculated as the number of completed required study assessments divided by the total number of scheduled required study assessments, multiplied by 100.
Adherence to Study Procedures
Percentage of required study procedures completed according to the study protocol among enrolled participants.
Participant Acceptability of the Comprehensive Management Strategy
Acceptability and satisfaction with the comprehensive biomarker-guided management strategy will be assessed among participants using an Acceptability and Satisfaction Questionnaire.
Clinician Acceptability of the Comprehensive Management Strategy
Acceptability and satisfaction with the comprehensive biomarker-guided management strategy will be assessed among participating clinicians using an Acceptability and Satisfaction Questionnaire.
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Hana Serajeddini
Lead sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor institution
St. Joseph's Health Care London
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
