Comprehensive Biomarker-Guided Management StrategyStandard of Care
Comprehensive Biomarker-Guided Management Strategy: Participants 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: Participants 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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).
* Eligible for initiation of biologic therapy for treatment of asthma or already on active treatment but not yet in a state of four-domain asthma remission.
* Women of childbearing potential (after menarche) must ensure that they are using an effective form of birth control for at least 2 months prior to each imaging visit. Examples of effective birth control include:
* True sexual abstinence
* A vasectomized sexual partner
* Implanon®
* Female sterilization by tubal occlusion
* Effective intrauterine device (IUD)/levonogestrel intrauterine system (IUS)
* Depo-Provera™ injections
* Oral contraceptive
* Evra Patch™
* Nuvaring™
* Women of childbearing potential (after menarche) must agree to use a highly effective form of birth control, as defined above, from enrollment, throughout the study duration.
Exclusion Criteria:
* 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.
* Patients who are pregnant or breastfeeding.
* Patients who are unable or unwilling to comply with study procedures.
* For the optional MRI procedure only: Patient has an implanted mechanically, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) (at the discretion of the MRI Technologist).
* In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the optional MRI or CT, such as severe claustrophobia.
* Other contraindications to MRI.
Primary outcome measure(s)
Eligibility Rate — During the study recruitment period 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 — During the study recruitment period The recruitment rate will be calculated as the number of participants enrolled divided by the duration of the recruitment period.
Enrolment Rate — During the study recruitment period 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 — Baseline(randomization) through Month 12 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.
Four-Domain Asthma Remission Rate in the Standard-of-Care Group — Baseline(randomization) through Month 12 Percentage of participants randomized to the standard-of-care (control) group who meet the protocol-defined criteria for 4-domain asthma remission at Month 12. The remission rate will be a corresponding confidence interval and will be used to inform sample size calculations for a future full-scale randomized controlled trial.
Trial sites (1)
Facility
City
Region
Status
St. Joseph's Health Care London
London
Ontario
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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