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 range18 Years – 65 Years
SexALL
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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…