NCT05564078Completed
IL-13 Blockade and 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
Source: ClinicalTrials.gov · Last updated 9 Jan 2026
Brief summary (registry, in English)
It has been observed that certain section of patients having severe to moderate Asthma, do not benefit from oral corticosteroids and IL-5 blocking biologics. There is increasing evidence that Airway auto immunity may be responsible for this poor response to treatment. It has been seen in earlier study done at Nair lab that these patients might benefit from Dupilumab, a biologic blocking IL-13/ IL-4. IL-13/IL-4 are the cytokines responsible for increased inflammation in these Asthmatics. The hypothesis is that blocking IL-13/IL-4 will also reduce the airway auto immunity which can be measured by comparing the auto immune markers in airway at baseline (before starting Dupilumab) and 16 weeks (after 4 months of Dupilumab treatment.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 30 (actual)
- First submitted
- 30 Sept 2022
- Start date
- 28 Sept 2022
- Primary completion date
- 17 Sept 2025
- Lead sponsor
- McMaster University
- Diseases
- Asthma
- NCT number
- NCT05564078
What you commit to
- Study type: Observational
- Participants enrolled: 30
- From 28 Sept 2022 to the primary completion date, 17 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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).
Other
- Ex-smokers with ≥ 20 pack-year smoking history
- Current pregnancy or lactation
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Research Institute of St. Joe's Hamilton Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.