Asthma (Diagnosis)
Conditions
Keywords
asthma, Severe Asthma, Biologic Therapy, Asthma Remission
Brief summary
This study will evaluate whether specialized tests of airway inflammation and lung abnormalities can better predict asthma remission and relapse than standard clinical assessments in adults with severe asthma who are starting biologic therapy. Participants will be randomly assigned to receive either standard asthma care or a comprehensive management approach guided by specialized biomarker results. Participants will be followed for 12 months and will undergo assessments including questionnaires, lung function testing, blood collection, sputum analysis, CT imaging, and MRI imaging. The results of this study may help improve the prediction of asthma outcomes and support more personalized treatment strategies for patients with severe asthma.
Detailed description
Current clinical assessments and conventional biomarkers have limited ability to predict which patients will respond most favorably to treatment. This pilot randomized controlled trial will evaluate whether specialized biomarkers of airway inflammation and lung abnormalities can better predict important asthma outcomes, including remission and relapse, than conventionally available biomarkers. The study will also assess whether a comprehensive management strategy guided by specialized biomarker assessments improves asthma outcomes compared with standard care. Fifty adults with severe asthma who are initiating biologic therapy will be enrolled and randomized in a 1:1 ratio to either a standard of care group or a comprehensive management group. Participants assigned to the comprehensive management group will have treatment decisions informed by specialized biomarker results, while clinicians caring for participants in the standard of care group will remain blinded to these results. Participants will be followed for 12 months and will undergo study assessments that include asthma questionnaires, pulmonary function testing, fractional exhaled nitric oxide (FeNO) testing, blood biomarker assessments, sputum cell analysis, computed tomography (CT) imaging, and magnetic resonance imaging (MRI). The study will compare asthma remission, relapse, airway inflammation, and structural airway abnormalities between groups. The findings from this study will provide preliminary evidence regarding the utility of specialized biomarkers and biomarker-guided management strategies in severe asthma and may inform future larger clinical trials and personalized treatment approaches.
Interventions
OTHERComprehensive Biomarker-Guided Management Strategy
Intervention Description 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.
OTHERStandard 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.
Sponsors
Hana Serajeddini
St. Joseph's Health Care London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will remain blinded to study arm allocation throughout the study. Clinicians are not blinded to study arm allocation because they will know whether specialized biomarker results are available to guide treatment decisions. Clinicians in the standard of care arm will be blinded to specialized biomarker results, while clinicians in the comprehensive management arm will have access to these results for clinical decision-making.
Intervention model description
Participants will be randomized in a 1:1 ratio to either a standard of care (control) group or a comprehensive management (intervention) group. Participants in both groups will undergo the same study assessments. In the intervention group, clinicians will have access to specialized biomarker results and may use these results to guide treatment decisions. In the control group, clinicians will remain blinded to specialized biomarker results, and treatment decisions will be based on standard clinical assessments and routine care. Participants will be followed for 12 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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. * 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, and X weeks after last dose of study drug, with negative urine pregnancy test result at Visit 1 and Visit 5. * Male participants who are sexually active must agree to use a double barrier method of contraception (male condom with diaphragm or male condom with cervical cap) from the first dose of the study drug until X weeks after last dose.
Exclusion criteria
* • Primary respiratory diagnoses other than asthma (e.g., COPD, bronchiectasis). * Patients with incomplete medical records. * Patients who have received biologic treatment for asthma within the last 6 months. * 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 MRI or CT, such as severe claustrophobia. * Patients with contraindications to PFT, sputum induction, CT or MRI imaging. * Patients who are pregnant or breastfeeding. * Patients who are unable or unwilling to comply with study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predictive Performance of Specialized Biomarkers for Asthma Remission and Relapse | Baseline to Month 12 | To evaluate the association between baseline specialized clinical, physiologic, airway inflammatory, and imaging biomarkers and asthma outcomes, including sustained remission and relapse, over the 12-month follow-up period. The predictive performance of specialized biomarkers will be compared with that of conventionally available biomarkers. |
Countries
Canada
Contacts
CONTACTHana Serajeddini, MD, FRCPC
Outcome results
None listed