A multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and Tolerability of Two Dosing Regimens of AllerT, a Combination of Contiguous Overlapping Peptides Derived from Bet v 1, in Adults with Birch Pollen Allergic Rhinitis/Rhinoconjunctivitis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
421
Combined Symptom and Medication Score (CSMS)
the CSMS will be assessed daily throughout the first birch pollen season following the end of the preseasonal 2-month treatment. The difference in average daily CSMS per treatment group will be compared taking into account all days of the birch pollen season at each study center. All patients will receive treatment during the preceding winter or spring and will thus have the primary outcome assessment performed between 2 and 6 months after the end of treatment.
Time frame: 2 to 6 months after the end of treatment
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Lungemedicinsk Forskningsafdeling,
Aarhus, Denmark
Herlev-Gentofte Hospital, Hud - og Allergiafdelingen,
Hellerup, Denmark
Kolding Hospital
Kolding, Denmark
Næstved Sygehus, Lungemedicinsk avd
Næstved, Denmark
Odense Universitetshospital
Odense, Denmark
Oulun Yliopistollinen sairaala Korva-, nenä- ja kurkkutautien poliklinikka.
Oulu, Finland
TYKS T-sairaala Allergiayksikkö TA2
Turku, Finland
HNO Heilkunde u. Allergologie praxis
Berlin, Germany
HNO Praxis Dr Yarin
Dresden, Germany
HNO Praxis Dr Thieme
Duisburg, Germany
...and 26 more locations