Allergic Rhino-Conjunctivitis Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled, Randomized Trial to Compare the Efficacy and Tolerability of Three Dose Regimens of AllerT, in Adults With Allergic Rhino-Conjunctivitis to Birch Pollen Studied in Environmental Exposure Chamber
The purpose of this study is to find the optimal dose of AllerT that should be used to treat
moderate to severe allergies due to birch tree pollen.
There are 4 treatment groups in this study; 3 treatment groups will receive AllerT at
different doses and 1 treatment group will receive placebo.
This study will also assess the effectiveness and safety of AllerT compared to placebo in
relieving allergy symptoms.
Primary Objective: To evaluate the dose-response trend of three doses of adjuvanted AllerT
and of placebo in reducing symptoms of allergic rhino-conjunctivitis in subjects exposed to
birch tree pollen in an environmental exposure chamber (EEC).
Secondary Objectives:
- To evaluate three dose regimens of AllerT , versus a placebo in reducing symptoms of
allergic rhino-conjunctivitis in subjects exposed to birch tree pollen in an EEC.
- To assess the safety and tolerability of a two month treatment with three dose
regiments of AllerT (10 µg, 25 µg and 50 µg with Al(OH)3).
- To explore the immunological response to AllerT.
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Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment