Dose-response trial with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Placebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4.
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg)
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg)
Prof. Dr. med. Ludger Klimek
Wiesbaden, Baden-W., Germany
Systemic reaction (according to Tryba)
Number of patients with at least one systemic reaction (according to Tryba Grade 1-4) with possible, probable or definite relationship to the study medication determined at the end of the uptitration phase.
Time frame: uptitration phase
Late Phase Reactions
Changes of the Late Phase Reactions in specific intracutaneous test with natural allergen before and at the end of the double-blind placebo controlled phase before grass pollen season.
Time frame: before and at the end of the double-blind phase
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg)
Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg)