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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
213
Inflamax Research Inc.
Mississauga, Ontario, Canada
The change in average Total Rhinoconjunctivitis Symptom Scores (TRSS) from the Baseline EEC Challenge (Visit 1 & Visit 2) to the Post-Treatment EEC Challenge (PTC) (Visit 8 & Visit 9).
The mean TRSS will be calculated for each subject from t =1 hour to t = 6 hours inclusive for the 2 consecutive days (22 time points) of Baseline and post-treatment EEC challenge.
Time frame: before entry in the EEC (time point = 0) and then every 30 minutes up to 6 hours in the EEC (12 time points)
Individual Nasal Symptom Scores (NSS)
• The change in the average of individual NSS from the Baseline EEC Challenge (Visit 1 \& Visit 2) to the Post-Treatment EEC Challenge (Visit 8 \& Visit 9).
Time frame: from t =1 hour to t = 6 hours inclusive for the 2 consecutive days (22 time points) of Baseline and post-treatment EEC challenge
Individual NSS
Individual NSS from Baseline EEC Challenge (Visit 1 \& Visit 2) to Post-Treatment EEC Challenge (Visit 8 \& Visit 9) (24 time points).
Time frame: All time points in the EEC for the 2 consecutive days (24 time points) of Baseline and post-treatment EEC challenge
The Global Evaluation of Treatment Efficacy Questionnaire
Time frame: Visit 9, after the last post-treatment EEC session.
The Asthma Symptom Score (ASS)
The mean ASS will be calculated for each subject from t =1 hour to t = 6 hours inclusive for the 2 consecutive days of the EEC challenge (22 time points). The following will be analyzed: * The change in the average ASS from the Baseline EEC Challenge (Visit 1 \& Visit 2) to the Post-Treatment EEC Challenge (Visit 8 \& Visit 9). * The change in the pre-EEC-Specific Quality of Life Questionnaire (EEC-Specific QoLQ) to post EEC-QoLQ will be calculated at Baseline EEC Challenge (Visit 1 \& Visit 2) and at Post-Treatment EEC Challenge (PTC) (Visit 8 \& Visit 9). Change of (post- pre-EEC) form Baseline to PTC will be compared between treatment groups.
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Time frame: before entry in the EEC (time point =0) and then every 30 minutes up to 6 hours in the EEC (12 time points)
The mean TRSS
The following will be analyzed: * The change in the average TRSS, from Baseline EEC Challenge (Visit 1 \& Visit 2) to Post-Treatment EEC Challenge (Visit 8 \& Visit 9) (24 time points). * The change in the average TRSS from the Baseline EEC Challenge (Visit 1, 12 time points) to the Post-Treatment EEC Challenge (Visit 8, 12 time points) will be calculated.
Time frame: All time points in the EEC for the 2 consecutive days (24 time points) of Baseline and post-treatment EEC challenge
The mean TNSS
The following will be analyzed: * The change in the average TNSS from Baseline EEC Challenge (Visit 1 \& Visit 2) to Post-Treatment EEC Challenge (Visit 8 \& Visit 9) (24 time points). * The change in the average TNSS from the Baseline EEC Challenge (Visit 1, 12 time points) to the Post-Treatment EEC Challenge (Visit 8, 12 time points) will be calculated.
Time frame: All time points in the EEC for the 2 consecutive days (24 time points) of Baseline and post-treatment EEC challenge
The mean TOSS
The following will be analyzed: * The change in the average TOSS from Baseline EEC Challenge (Visit 1 \& Visit 2) to Post-Treatment EEC Challenge (Visit 8 \& Visit 9) (24 time points). * The change in the average TOSS from the Baseline EEC Challenge (Visit 1, 12 time points) to the Post-Treatment EEC Challenge (Visit 8, 12 time points) will be calculated.
Time frame: All time points in the EEC for the 2 consecutive days (24 time points) of Baseline and post-treatment EEC challenge
The mean Total Nasal Symptom Scores (TNSS)
The following will be analyzed: • The change in the average TNSS from the Baseline EEC Challenge (Visit 1 \& Visit 2) to the Post-Treatment EEC Challenge (Visit 8 \& Visit 9).
Time frame: from t =1 hour to t = 6 hours inclusive for the 2 consecutive days (22 time points) of Baseline and post-treatment EEC challenge
Total Ocular Symptom Score (TOSS)
• The changes in the average TOSS from the Baseline EEC Challenge (Visit 1 \& Visit 2) to the Post-Treatment EEC Challenge (Visit 8 \& Visit 9).
Time frame: before entry in the EEC (time point = 0) and then every 30 minutes up to 6 hours in the EEC (12 time points)