Airway Auto Immunity in AsthmaIL-SAANCT05564078
IL-13 Blockade and Airway Autoimmunity in Asthma
An observational study of Airway Auto Immunity in Asthma, run by McMaster University at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Airway Auto Immunity in Asthma
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 28 Sep 2022to 17 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: Severe asthmatics on newly prescribed Dupilimab.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Research Institute of St. Joe's Hamilton
Hamilton, Ontario, L8N4A6
About this study
Official title: 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
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.
Read the detailed description
Asthma, a chronic airway disease characterized by reversible airflow, airway inflammation and hyper responsiveness. A prominent phenotype is eosinophilic asthma, with a prevalence rate of ~50% and characterised by blood eosinophils >300 cells/μL and sputum eosinophils >3%. Inhaled corticosteroids (ICS) have been successful for treatment of mild-to-moderate asthma. However, ~10% of eosinophilic asthmatics remain uncontrolled despite being on high dose oral corticosteroids. This small percentage contributes disproportionately to 80% of asthma healthcare costs [8-10]. As a steroid-sparing strategy, monoclonal antibody (mAb) therapies targeting interleukin (IL)-5 signalling have been developed that are projected to benefit this difficult-to-treat population. Yet, a subset (30-50%) of them remain symptomatic despite being on oral corticosteroids (OCS) and adjunct anti-IL-5 mAb. Anti- eosinophil peroxidase (EPX) Immunoglobulin G (IgG) levels in the airways strongly correlated with the presence of other auto antibodies, in particular the anti-nuclear antibodies (ANAs) as well as various clinical features of asthma severity. Therefore, a better understanding of the underlying pathology with subsequent identification of clinical/molecular biomarkers remains an unmet clinical need for optimal asthma management. Airway autoimmune responses in severe asthma is an important contributor to airway mucus and this can be ameliorated by blocking the IL-4/IL-13 inflammatory axis.
- Conditions
- Airway Auto Immunity in Asthma
- Keywords
- auto immune, severe asthmatics, exacerbations, eosinophilic Asthma
- Medical subject headings
- Asthma, Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Eosinophilic Asthma | Not described | |
| Subjects without Asthma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of severe asthmatics with a reduction in anti-EPX IgG in airway secretions (marker of airway autoimmunity)
Reduction in anti-EPX IgG
Measured: 12 weeks
Secondary outcomes (3)
To determine the effect of dupilumab on luminal plugging (CT mucus score) and airway obstruction (FEV1) from baseline to post 4 months of therapy
CT mucus score
Measured: 12 weeks
To associate changes with respect to clinical indices of asthma control: blood eosinophils, fractional exhaled nitric oxide (FeNO) and asthma control questionnaire (ACQ)
Blood eosinophil count
Measured: 12 weeks
To determine the changes in sputum composition (sputum eosinophils, neutrophils, free eosinophil granules) and inflammatory mediators (eosinophil peroxidase, T2 cytokines and chemokines) from baseline to post 4 months of therapy
Sputum cell differential count
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start28 Sep 2022
- Primary completion17 Sep 2025
- Study completion17 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Auto Immunity in AsthmaStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Manali Mukherjee, PHD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564078
- Sponsor's protocol ID
- 14816
- Acronym
- IL-SAA
- Status last verified
- Dec 2025
- First submitted
- 30 Sep 2022
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05564078
- Acronym / sponsor ID
- IL-SAA / 14816
- Conditions
- Airway Auto Immunity in Asthma
- Keywords
- auto immune, severe asthmatics, exacerbations, eosinophilic Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 17 Sep 2025 (actual)
- Study completion
- 17 Sep 2025 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Asthma, a chronic airway disease characterized by reversible airflow, airway inflammation and hyper responsiveness. A prominent phenotype is eosinophilic asthma, with a prevalence rate of ~50% and characterised by blood eosinophils >300 cells/μL and sputum eosinophils >3%. Inhaled corticosteroids (ICS) have been successful for treatment of mild-to-moderate asthma. However, ~10% of eosinophilic asthmatics remain uncontrolled despite being on high dose oral corticosteroids. This small percentage contributes disproportionately to 80% of asthma healthcare costs [8-10]. As a steroid-sparing strategy, monoclonal antibody (mAb) therapies targeting interleukin (IL)-5 signalling have been developed that are projected to benefit this difficult-to-treat population. Yet, a subset (30-50%) of them remain symptomatic despite being on oral corticosteroids (OCS) and adjunct anti-IL-5 mAb. Anti- eosinophil peroxidase (EPX) Immunoglobulin G (IgG) levels in the airways strongly correlated with the presence of other auto antibodies, in particular the anti-nuclear antibodies (ANAs) as well as various clinical features of asthma severity. Therefore, a better understanding of the underlying pathology with subsequent identification of clinical/molecular biomarkers remains an unmet clinical need for optimal asthma management. Airway autoimmune responses in severe asthma is an important contributor to airway mucus and this can be ameliorated by blocking the IL-4/IL-13 inflammatory axis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with Eosinophilic Asthma | – | – |
| Subjects without Asthma | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Severe asthmatics on newly prescribed Dupilimab.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of severe asthmatics with a reduction in anti-EPX IgG in airway secretions (marker of airway autoimmunity)
Time frame: 12 weeks
Reduction in anti-EPX IgG
3 secondary outcomes
To determine the effect of dupilumab on luminal plugging (CT mucus score) and airway obstruction (FEV1) from baseline to post 4 months of therapy
Time frame: 12 weeks
To associate changes with respect to clinical indices of asthma control: blood eosinophils, fractional exhaled nitric oxide (FeNO) and asthma control questionnaire (ACQ)
Time frame: 12 weeks
To determine the changes in sputum composition (sputum eosinophils, neutrophils, free eosinophil granules) and inflammatory mediators (eosinophil peroxidase, T2 cytokines and chemokines) from baseline to post 4 months of therapy
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manali Mukherjee, PHD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Auto Immunity in Asthma, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of severe asthmatics with a reduction in anti-EPX IgG in airway secretions (marker of airway autoimmunity) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.