Therapeutic Relevance of Abnormal Airway Morphology in Asthma: A Path to Optimized Management and Drug Development (AirPATH Study)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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, 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
St. Joseph's Healthcare Hamilton
RECRUITING
Hamilton
Western University
NOT_YET_RECRUITING
London
Contact Information
Primary
Sarah Svenningsen, PhD
svennins@mcmaster.ca
(905) 522-1155 Ext. 32195
Backup
Yonni Friedlander, PhD
yfriedla@stjoes.ca
(905) 522-1155 Ext. 32195
Time Frame
Start Date: 2025-06-02
Estimated Completion Date: 2028-06
Participants
Target number of participants: 242
Treatments
Experimental: Uncontrolled eosinophilic asthma
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.
Related Therapeutic Areas
Sponsors
Leads: McMaster University

This content was sourced from clinicaltrials.gov