Objective of the study is to show, on an exploratory basis, that treatment with SUBLIVAC Birch is also effective compared to treatment with Staloral Birch by means of reduction in allergic symptoms during nasal provocation in subjects suffering from IgE mediated allergic complaints triggered by birch pollen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
74
Start with 1 drop daily of SUBLIVAC Birch and increase by 1 drop daily, until the maintenance dose of 5 drops is reached. This maintenance dose should then be taken daily. Or 1 puff of Staloral Birch 10 I.R./ml on day one, 2 puffs on day two and increase by 2 puffs until at day six 10 puffs are reached. At day seven 1 puff of Staloral Birch 300 I.R./ml is taken, at day eight 2 puffs and day nine 4 puffs. From then on 4 puffs daily are taken. Route of administration: Sublingual application. Drops (for SUBLIVAC Birch) or puffs (for Staloral Birch) are to be held underneath the tongue and then will be swallowed. Duration of treatment: 16-20 weeks per subject (at least 12 weeks for subjects with hazel or alder allergy).
Zentrum für Rhinologie & Allergologie
Wiesbaden, Hesse, Germany
Difference in change of the titrated nasal provocation test (TNPT) between the two treatment groups
Time frame: 16-20 weeks of treatment
Immunoglobulins, changes in TNPT derived variables
Time frame: 16-20 weeks of treatment
Determination of specific IgE and specific IgG to birch at the baseline and the end of study. It is expected that changes in specific IgE and IgG will be equal in both treatment groups
Time frame: 16-20 weeks of treatment
At the baseline and the end of study visit the subject will be asked questions for the evaluation of oral allergy syndrome. It is expected that the reduction of oral allergy syndrome complaints will be equal in both treatment groups.
Time frame: 16-20 weeks of treatment
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