The purpose of this study is to determine the efficacy and safety of three doses of r Bet v1 administered as sublingual tablets in birch pollen allergic subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
483
One sublingual tablet of matching placebo daily during approximately 5.5 months
One sublingual tablet containing rBet v 1 at a dosage of 12.5 µg daily during approximately 5.5 months
One sublingual tablet containing rBet v 1 at a dosage of 25 µg daily during approximately 5.5 months
National University Hospital - Allergy Unit 4222
Copenhagen, Denmark
Helsingin yliopistollinen keskussairaala
Helsinki, Finland
NHC, Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Charité universitaetsmedizin
Berlin, Germany
Average Adjusted Symptom Score
Time frame: ~1 month (whole birch pollen season)
Average Rhinoconjunctivitis Total symptom Score
Time frame: ~1 month (whole birch pollen season)
Rescue Medication Score
Time frame: ~1 month (whole birch pollen season)
Average Combined Score
Time frame: ~1 month (whole birch pollen season)
Proportion of symptom-controlled days
Time frame: ~1 month (whole birch pollen season)
Global evaluation by the patient
Time frame: after 5-6 months of treatment
Immunological markers (IgE and IgG4)
Time frame: 6-7 months
Sensitisation status
Time frame: At least 6 months
Lower airways symptoms
Time frame: ~1 month (whole birch pollen season)
Safety assessments
Time frame: 6-7 months
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One sublingual tablet containing rBet v 1 at a dosage of 50 µg daily during approximately 5.5 months
Public Institution Kaunas Medical University Hospital
Kaunas, Lithuania
SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi
Lodz, Poland
Institute of Immunology of FMBA
Moscow, Russia
Sabina RAK
Gothenburg, Sweden