Status:
RECRUITING
Therapeutic Relevance of Abnormal Airway Morphology in Asthma
Lead Sponsor:
McMaster University
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Most individuals with asthma can effectively manage their symptoms and maintain normal lung function using inhaled medications, unfortunately, there is a subset of asthma sufferers whose symptoms, lun...
Detailed Description
The cornerstone of asthma management lies in inhaled medications, including corticosteroids (ICS) and long-acting beta2-agonists (LABA). Unfortunately, individual responses to these first-line inhaler...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT06970080
Start Date
June 2 2025
End Date
June 1 2028
Last Update
September 11 2025
Active Locations (2)
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1
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N4A6
2
Western University
London, Ontario, Canada, N6A 3K7