The primary aim of this trial is to evaluate the dose-response relationship for the ALK tree AIT administered once daily in order to define a dose-range that would be suitable for at-home administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
637
Skin and Allergy Hospital, Helsinki University Central Hospital
Helsinki, HUS, Finland
Slotervaart Ziekenhuis
Amsterdam, Netherlands
Allergy symptom severity scores on a scale from 0-3
Determine the dose-efficacy response relationship of the ALK tree AIT. This information will, in combination with the evaluation of the frequency and severity of adverse events, form the basis of the conclusion on the primary endpoint.
Time frame: During the birch pollen season 2013, an expected average of 3 weeks
Adverse events frequency
Determine the dose-safety response relationship of the ALK tree AIT. This information will, in combination with the evaluation of the allergy symptoms, form the basis of the conclusion on the primary endpoint.
Time frame: Throughout the trial, an expected average of 8 months
Adverse events severity
Determine the dose-safety response relationship of the ALK tree AIT. This information will, in combination with the evaluation of the allergy symptoms, form the basis of the conclusion on the primary endpoint.
Time frame: Throughout the trial, an expected average of 8 months
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