The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Phleum pratense based on reduction of upper airways reactivity after 5 months of treatment with different dosages of SUBLIVAC FIX Phleum pratense compared to placebo. Furthermore, safety and tolerability will be assessed by the number of related Adverse Events of different dosages of SUBLIVAC FIX Phleum pratense compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
266
Comparison of different dosages to placebo
CIMS Studienzentrum Bamberg
Bamberg, Germany
Nasal Provocation Test (NPT)
Time frame: 5 months
Number of related AEs
Time frame: First ten days of study medication intake
Serum specific immunoglobulin levels (IgE, IgG, IgG4)
Time frame: 5 months
Number of local and systemic reactions
Time frame: Duration of study medication intake (approximately 5 months)
Peak Nasal Inspiratory Flow (PNIF)
Time frame: 5 months
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