Determining how memory T helper type 2 (Th2) initiate recall responses to aeroallergens has the potential to change the therapeutic approach to allergic asthma, the most common asthma subtype. \~5-10% of effector Th2 cells recruited into the lung give rise to long-lived tissue resident memory cells that are poised to respond upon allergen re-exposure.Consequently, targeting memory Th2 cell activation is an attractive therapeutic strategy. However, it is not well understood how allergen inhalation initiates a memory Th2 cell response in the lung. The focus of this new study on the role of lung-resident memory Th2 cells in orchestrating the recall response to allergen in the lung, including the recruitment and activation of circulating Th2 cells, is a natural, timely and exciting extension of the investigators' ongoing Allergen Challenge Protocol.
Who can participate
Age range
18 Years – 55 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
. All subjects will have a baseline FEV1 no less than 75% of the predicted value.
. All subjects will have a clinical history of allergic symptoms to an indoor allergen present in their home environment, either cat, dog or dust mite allergen, and confirmed skin reactivity (a positive allergen prick test) to the same allergen. The investigators will recruit both:
. subjects with mild intermittent or mild persistent asthma (consistent with NAEP Step 1 or Step 2 treatment options) who are not taking regular daily inhaled corticosteroids (ICS), and
. subjects with moderate persistent asthma (consistent with NAEP Step 3 treatment options) who are taking regular daily inhaled corticosteroids (ICS). In this subgroup, the maximum allowable daily ICS dose will be 220 MCG twice daily of fluticasone or equivalent ICS at screening.
. Life-long absence of cigarette smoking (lifetime total of \< 5 pack-years and none in 5 years).
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.
What they're measuring
1
The phenotype of Th2-Trm recovered from the airway mucosa
Timeframe: This is a single time point study with all information obtained at the time of bronchoscopy defined as Day 0.
2
The transcriptional profile of Th2-Trm recovered from the airway mucosa
Timeframe: This is a single time point study with all information obtained at the time of bronchoscopy defined as Day 0.
. Expressed the desire to participate in an interview with the principal investigator.
. Age between 18 and 55 years.
Exclusion criteria
. Women of childbearing potential who are pregnant (based on urine beta-HCG testing), are sexually active and not using contraception, are seeking to become pregnant or who are nursing.
. The presence of spontaneous asthmatic exacerbation or clinical evidence of upper respiratory tract infection within the previous 6 weeks and not requiring a change in daily inhaled corticosteroids (ICS) in the past 4 weeks.
. Participation in a research study involving a drug or biologic agent during the 30 days prior to the study.
. Intolerance to albuterol, atropine, lidocaine, fentanyl, or midazolam.
. Antihistamines within 7 days of the screening visit.
. Presence of diabetes mellitus, congestive heart failure, ventricular arrhythmias, history of a cerebrovascular accident, renal failure, history of anaphylaxis or cirrhosis.
. Use of systemic steroids, increased use of inhaled steroids, beta blockers and MAO inhibitors or a visit for an asthma exacerbation within 1 month of the screening visit.
. Antibiotic use for respiratory disease within 1 month of the characterization visit or a respiratory tract infection within 6 weeks of the bronchoscopy visits.