Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic disease the aim of this study was to assess safety and tolerability of three different subcutaneous immunotherapy dose escalations in patients allergic to the pollen of Phleum pratense.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
Increasing doses up to a maximum dose of 500 TSU
Hospital Ramón y Cajal
Madrid, Spain
Number and seriousness of both local and systemic adverse reactions
Time frame: From informed consent signature (V0) until the end of patient participation in the study (depending on the treatment assigned between 4 and 8 weeks )
Immunoglobulin levels (IgE specific, IgG total and IgG4) and prick test dose response
Time frame: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
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