Blocking IL-13 to address airway autoimmunity in asthma
A Single-centre, Observational, Prospective Study to Investigate the Effect of IL-13/IL-4 Blockade on Reducing Markers of Airway Autoimmunity in Severe Asthmatics
This study is testing whether a new treatment that blocks a specific protein can help people with severe asthma who haven't responded to other medications feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | McMaster University Academic / other |
| Drugs / interventions | dupilumab, prednisone |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT05564078 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the role of IL-13 blockade in patients with severe asthma who do not respond to standard treatments like oral corticosteroids and IL-5 blocking biologics. It aims to understand the relationship between airway autoimmunity and asthma severity by measuring autoimmune markers before and after treatment with Dupilumab, a biologic that targets IL-13 and IL-4. The study will enroll patients diagnosed with asthma for at least 36 months and who are clinically indicated for Dupilumab therapy. The outcomes will help clarify the underlying pathology of asthma in this difficult-to-treat population.
Who should consider this trial
Good fit: Ideal candidates are patients with severe eosinophilic asthma who have been on high-dose corticosteroids and are clinically indicated for Dupilumab treatment.
Not a fit: Patients who are current smokers, pregnant, or have a significant history of smoking may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with severe asthma who currently have limited therapeutic options.
How similar studies have performed: Previous studies have shown promise in targeting IL-13 and IL-4 in asthma treatment, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Prior to the beginning of the study, patients must be willing and fully capable to provide written informed consent * Subjects must be able and willing to comply with the study protocol * Asthma diagnosed by a respiratory physician ≥ 36 months prior to study enrollment based on the Global Initiative for Asthma (GINA) 2014 guidelines * Patients referred or routinely followed for asthma by Dr. Nair * Clinical indication to prescribe dupilumab or will enter a clinical trial where patient will receive drug for at least 4 months * ICS dose ≥ 500 mcg of fluticasone equivalent/day, and/or daily prednisone Exclusion Criteria: * Current smoker defined as having smoked at least one cigarette (or pipe, cigar, or marijuana) per day for ≥ 30 days within the three months prior to screening * Ex-smokers with ≥ 20 pack-year smoking history * Current pregnancy or lactation * Treatment with anti- Immunoglobulin E (IgE), anti-IL-5, or anti-IL-5 Receptor targeted therapy currently or within three months prior to Visit 1 * Any prior medical conditions or treatment history that the physician deems unfit (including but not restricted to chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension, tuberculosis).
Where this trial is running
Hamilton, Ontario
- The Research Institute of St. Joe's Hamilton — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Manali Mukherjee, PHD — McMaster University
- Study coordinator: Manali Mukherjee, PhD
- Email: mukherj@mcmaster.ca
- Phone: 9055221155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.