Allergy Clinical Trial
Official title:
Intralymphatic Specific Immunotherapy - as a New Treatment Form for Grass-pollen Allergic Subjects
The purpose of the study is to try a new route for specific immunotherapy (SIT). The current
treatment form for SIT is subcutaneously (SCIT), which is a long treatment with up to 50
injections subcutaneously in the upper arm.
The investigators believe that there is additional effect if the allergen is injected
directly into the lymph node, since it is here, the allergen presentation is happening. The
trial has been performed in Switzerland with significant effect of only three injections of
grass-allergen into a lymph node (Clinicaltrials.gov; NCT00470457).
The investigators would like to see what happens if the the dose is doubled, so the patients
will receive 6 injections all in all, with the same amount of allergen as the earlier study
(1000 SQ-U). Also the outcome measurements is slightly different as the patients will note
their symptoms in a diary.
The patients will be divided into three groups using allocation:
1 group with 6 injections of allergen
1 group with 3 injections of allergen and 3 injections of placebo
1 group with 6 injections of placebo. The trial will be double blinded.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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