Corticosteroids for Asthma

(AirPATH Trial)

Recruiting at 1 trial location

Overseen By Yonni Friedlander, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: McMaster University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

242 Participants Needed

Trial Summary

What is the purpose of this trial?

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, lung function, and risk of asthma attacks remain unimproved despite conventional inhaled medications. There could be several reasons for this. One possibility is that inhaled medications fail to reach the intended areas within the lungs, due to structural abnormalities within the airways themselves. Much like road conditions or closures can impede the speed and efficiency of vehicle travel, factors such as airway narrowing or mucus blockages, which are common in asthma, can obstruct the passage of inhaled medications through the airways. Our team has now optimized advanced medical imaging techniques, including magnetic resonance imaging (MRI) and computed tomography (CT), required to investigate this. This study will use these imaging methods to visually assess and measure individual patients' airways and determine whether abnormal airway structures impact how well they respond to inhaled and orally delivered medications. We anticipate finding that abnormal airway structures make inhaled medications less effective, but that they do not affect the response to oral medications.

Eligibility Criteria

This trial is for asthma patients who don't get better with regular inhaled meds. It's likely because the meds can't reach all parts of their lungs due to airway issues like narrowing or mucus. To join, they need a detailed lung scan using MRI or CT.

Inclusion Criteria

Able and willing to provide written informed consent

Able and willing to comply with the study protocol

ACQ ≥1.5 during the screening period

Exclusion Criteria

Non-English speaking

Unable to undergo MRI due to implanted devices or metal in body, severe claustrophobia, or other conditions preventing MRI performance.

Pregnant or breastfeeding

Treatment Details

Interventions

• Inhaled corticosteroid (ICS)
• Oral Corticosteroid (OCS)

Trial Overview The study tests if abnormal airways affect how well inhaled and oral asthma meds work. Using advanced imaging (MRI/CT), researchers will see if these structural problems make inhaled drugs less effective compared to oral ones.

Participant Groups

Group I: Uncontrolled eosinophilic asthma Experimental Treatment 2 Interventions

In Phase I, participants will receive a doubling of their current ICS dose. If their asthma remains uncontrolled, they will receive an OCS burst in phase II.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+