Recruiting

Medical Imaging

Sponsor:

McMaster University

Code:

NCT06970080

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Inhaled corticosteroid (ICS)

Oral Corticosteroid (OCS)

Study Details

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, 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.

Conditions

Asthma

Study ID

NCT06970080

Start date

Jun 2, 2025

Status verified date

Sep, 2025

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

242 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Inhaled corticosteroid (ICS)

In Phase I, participants will receive additional same dose of extra-fine particle ICS (i.e., their ICS would be doubled) for 12-weeks.

Oral Corticosteroid (OCS)

In phase II, participants will receive add-on oral prednisone (30mg/day) for one-week.

Primary outcome measure

  • Biological response to additional ICS [ Time Frame: 12 weeks ]
  • Biological response to add-on OCS [ Time Frame: 1 week ]

Central Contacts and Locations

Central contacts

Sarah Svenningsen, PhD

(905) 522-1155 Ext. 32195svennins@mcmaster.ca

Yonni Friedlander, PhD

(905) 522-1155 Ext. 32195yfriedla@stjoes.ca

Locations

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N4A6

Contacts

Sarah Svenningsen, PhD

905-522-1155svennins@mcmaster.ca

More Information

Sponsor

McMaster University

Last update posted

Sep 11, 2025

Last verified

Sep, 2025

Keywords

  • asthma
  • computed tomography
  • corticosteroids
  • inhaled drug deposition
  • magnetic resonance imaging
  • airway morphology
  • eosinophilic inflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2025-09-11.