A Dose-response Evaluation of the SQ Tree SLIT-tablet Using an Environmental Exposure Chamber (NCT02481856) | Clinical Trial Compass
CompletedPhase 2
A Dose-response Evaluation of the SQ Tree SLIT-tablet Using an Environmental Exposure Chamber
Canada219 participantsStarted 2015-06
Plain-language summary
The trial is a phase II, randomised, parallel-group, double-blind, placebo-controlled multi-site trial conducted in Canada. Before the start of treatment, the subjects will undergo baseline birch and oak Environmental Exposure Chamber sessions. The treatment duration is 24 weeks. The subjects will undergo birch Environmental Exposure Chamber sessions after 8, 16 and 24 weeks of treatment and an oak Environmental Exposure Chamber session after 24 weeks of treatment.
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:
* Written informed consent obtained before any trial related procedures are performed
* Male or female aged 18 to 65 years
* Female subjects of child-bearing potential must have a negative urine pregnancy test and be willing to practise contraceptive methods
* History of moderate-to-severe rhinoconjunctivitis induced by pollens from the birch group with or without asthma despite having received treatment with symptom relieving medication during the previous 2 tree pollen seasons
* Positive SPT response (wheal diameter ≥ 3 mm) to Betula verrucosa
* Positive specific IgE against Bet v1 (≥ IgE Class 2; ≥0.70 kU/L)
* Willing and able to comply with the trial protocol
* Minimum level of rhinoconjunctivitis symptoms, defined as a TSS of at least 7 (of 18), at one timepoint during birch baseline EEC session.
Exclusion Criteria:
* Symptoms induced by interfering allergens that are expected to be present during the periods where the subject attends the EEC sessions
* Rhinoconjunctivitis caused by animal hair and dander to which the subject is regularly exposed.
* Allergic symptoms induced by perennial allergens such as house dust mites, and moulds
* A clinical history of uncontrolled asthma within 3 months prior to screening
* Reduced lung function FEV1 (\< 70% of predicted value after adequate pharmacological treatment)
* Asthma requiring treatment with inhaled corticosteroid within the past 3 months prior to screening
* Previous treatment with any allergy immu…
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.