How abnormal airway shape affects asthma treatment options.
Therapeutic Relevance of Abnormal Airway Morphology in Asthma: A Path to Optimized Management and Drug Development (AirPATH Study)
This project will try to see if MRI and CT pictures of airway shape can help predict which adults with uncontrolled eosinophilic asthma do better with inhaled versus oral corticosteroids.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 242 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McMaster University Academic / other |
| Drugs / interventions | prednisone |
| Locations | 2 sites (Hamilton, Ontario and 1 other locations) |
| Trial ID | NCT06970080 on ClinicalTrials.gov |
What this trial studies
AirPATH is an open-label, two-phase interventional study enrolling adults with uncontrolled eosinophilic asthma. Participants receive advanced MRI and CT imaging to measure airway morphology and function, along with physiologic testing (methacholine challenge or bronchodilator response), sputum eosinophils, and FeNO. In a 12-week Phase I, responses to inhaled corticosteroid therapy and a course of oral corticosteroids are compared to imaging-derived metrics to see whether airway structure affects drug delivery and clinical response. The study aims to identify imaging markers that could indicate when systemic therapy may better reach diseased airways than inhaled treatment.
Who should consider this trial
Good fit: Adults (≥18 years) with physician-diagnosed, uncontrolled eosinophilic asthma (ACQ ≥1.5 and sputum eosinophils ≥3% or FeNO ≥35 ppb, plus airway hyperresponsiveness or bronchodilator reversibility) who can attend study visits and consent.
Not a fit: People who smoke, are pregnant or breastfeeding, have significant other lung diseases, recent oral steroids or biologic therapy, or non-eosinophilic asthma are excluded and unlikely to benefit from the imaging-guided comparisons in this protocol.
Why it matters
Potential benefit: If successful, clinicians could use imaging to personalize whether a patient should receive inhaled or oral corticosteroids, potentially improving symptom control and reducing asthma attacks.
How similar studies have performed: This application of CT/MRI to guide the choice between inhaled and oral corticosteroids is novel; prior imaging work has characterized airway abnormalities but has not directly used those images to direct steroid route of delivery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able and willing to provide written informed consent. * Able and willing to comply with the study protocol. * Males and females ≥ 18 years of age. * Asthma diagnosed by a respiratory physician. * Airway hyperresponsiveness (defined as methacholine PC20 ≤8mg/mL) and/or bronchodilator reversibility (defined as post-bronchodilator FEV1 improvement ≥200mL and 12%) in the last 6 months * ACQ ≥1.5 during the screening period. * Sputum eosinophils ≥3% and/or FeNO ≥35ppb during the screening period. Exclusion Criteria: * Current smoker, defined as someone having smoked ≥1 cigarette/day (or vape/pipe/cigar/marijuana) for ≥30 days within 12 months prior to screening. * Pregnant or breastfeeding * Non-English speaking * Oral corticosteroids in past 1-month * Biologic therapy in past 6-months * Unable to perform proper MDI technique during the screening period * Other pulmonary diseases (e.g., chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension, tuberculosis) requiring treatment within 12 months prior to screening. * Unable to undergo MRI. 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). Suffers from any physical, psychological, or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia.
Where this trial is running
Hamilton, Ontario and 1 other locations
- St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada (Recruiting)
- Western University — London, Ontario, Canada (Not_yet_recruiting)
Study contacts
- Study coordinator: Sarah Svenningsen, PhD
- Email: svennins@mcmaster.ca
- Phone: (905) 522-1155 Ext. 32195
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.