The aim of this phase III study is to asses if SUBLIVAC FIX Birch is safe and effective in reducing birch allergy induced symptoms and birch allergy medication usage.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Signed informed consent
* Age ≥ 18 and ≤65 years
* Moderate-to-severe birch pollen induced allergic rhinitis/rhinoconjunctivitis based on ARIA classification for at least 2 consecutive years
* FEV1 (forced expiratory volume at one second) \> 70% (of predicted value) for patients with a history of asthma, FEV1 \> 70% or PEF (peak expiratory flow) \> 80% (of predicted value) for patients without a history of asthma
* Positive SPT (skin prick test) for birch pollen (mean wheal diameter ≥ 3mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter ≥ 3mm)) assessed during screening.
* Serum specific anti-birch IgE (immunoglobulin E) concentration \>0.7 U/ml
* Patients should be willing and capable to complete an e-diary daily during the birch pollen season (≥ 60% compliance in completion between Visit 1 and 2).
* A positive Nasal Provocation Test to birch pollen at Visit 2 (Lebel score ≥ 6) or a documented positive test within 1 year before start of treatment
Exclusion Criteria:
* Patients sensitized and symptomatic to pets should not be included if they are regularly exposed to pets
* Specific immunotherapy (SCIT or SLIT) with birch pollen or a cross-reacting allergen within the last 5 years
* SPT positive (mean wheal diameter ≥ 3mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter ≥ 3mm)) patients to allergen(s) …