Understanding Airway Structure's Impact on Asthma Treatment
Therapeutic Relevance of Abnormal Airway Morphology in Asthma
Recruiting
Phase 4Interventional Study
Asthma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
242 (estimated)
Sponsor
McMaster University · Other
Who this trial is looking for
This trial is looking for adults with asthma who want to help researchers understand how abnormal airway structures affect asthma treatment. Participants will undergo imaging tests to look at their airways and assess their medication responses.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with asthma.
I can provide written consent.
I can follow the study rules.
I had airway hyperresponsiveness or improvement in lung function recently.
I had a score of 1.5 or higher on the Asthma Control Questionnaire.
My sputum eosinophils are 3% or higher, or my FeNO levels are 35 ppb or higher.
You may not be able to join if
I smoke cigarettes or have smoked any tobacco or similar products regularly in the last year.
I am pregnant or breastfeeding.
I do not speak English.
I have taken oral corticosteroids in the past month.
I have received biologic therapy in the past 6 months.
I cannot use my inhaler properly.
I have other serious lung diseases in the last year.
I cannot undergo an MRI due to metal implants or other reasons.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 th…
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.
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Eligibility 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 bronchod…
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.
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