IL-13 Blockade and Airway Autoimmunity in Asthma

Launched by MCMASTER UNIVERSITY · Sep 30, 2022

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ClinConnect Summary

This clinical trial is studying a new treatment for patients with severe to moderate asthma who do not respond well to standard treatments like oral corticosteroids. Researchers believe that a condition called airway autoimmunity might be the reason these patients struggle with their asthma. The trial will test a medication called Dupilumab, which blocks certain substances in the body that cause inflammation, and see if it helps reduce both asthma symptoms and markers of airway autoimmunity over a period of 16 weeks.

To participate in this trial, patients need to have had asthma diagnosed for at least three years and currently be on a high dose of asthma medication. They must also be willing to follow the study rules and provide consent. However, certain people, such as current smokers or those who have recently used other specific asthma treatments, may not be eligible. Participants can expect to receive Dupilumab for at least four months, and researchers will closely monitor their progress to see how well the treatment works.

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Eligibility 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).