Tezepelumab and Methacholine Airway Hyperresponsiveness in Participants With Mild Allergic Asthma (NCT05740748) | Clinical Trial Compass
UnknownPhase 2
Tezepelumab and Methacholine Airway Hyperresponsiveness in Participants With Mild Allergic Asthma
Canada34 participantsStarted 2023-04-01
Plain-language summary
Asthma is a condition where small inhaled particles can cause inflammation in the lung leading to constriction of airways and wheeze. Mast cells are immune cells in airways that can release chemical causing constriction of the airways and wheeze. Tezepelumab is an injectable medication that improves asthma by stopping inflammation, but the effect on mast cells is not known. Tezepelumab was approved in Canada July 2022 for treatment of severe asthma. Tezepelumab is not approved for treatment of mild asthma by any health authority, except for use in research studies like this. This study will examine the effect of tezepelumab on mast cells and airway constriction to understand the mechanisms of asthma, and which patients will benefit most from drugs like tezepelumab.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provision of informed consent prior to any study specific procedures
. Male and female 18 through 65 years of age
. Positive skin-prick test to a common aeroallergen
. Methacholine PD20 ≤ 200mcg
. Mannitol DRR ≤ 42.3mg/FEV1 %f all (equivalent to PD15 ≤ 635mg)
. Baseline FEV1 ≥ 70% of the predicted value
. Negative pregnancy test (urine) for female participants of childbearing potential.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Current or former smoker with \>10-pack-year history
. Current or previous history of lung disease other than mild stable allergic asthma
. Significant systemic disease, including history of current malignancy or autoimmune disease
. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
. Previous randomisation in the present study. Re-screening (Week -1) for FEV1 and AHR is permitted once for each test.
. Participation in another clinical study with an investigational product during the last 30 days or 5 half-lives of the drug (whichever is longer)
. Use of any medications for treatment of asthma other than prophylactic short-acting β2-agonists, or use of short-acting β2-agonists for relief of symptoms less than once weekly.
. Participants with known hypersensitivity to tezepelumab or any of the excipients of the product.