Rhinitis, Allergic, Seasonal Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of TOLAMBA™ in the Control of Symptoms of Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Model
This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter
study. After passing the initial Screening Visit, subjects will be in the environmental
exposure chamber(EEC), a room with a controlled amount of ragweed pollen, for 4 hours each
day on 4 consecutive days. At the last visit, subjects who have achieved a minimum Total
Nasal Symptom Score (TNSS) will be randomized to receive either TOLAMBA or placebo
treatments. Subjects will receive 6 weekly subcutaneous (under the skin) injections of the
study drug. About three weeks after the last injection, subjects will be asked to be in the
EEC for 2 consecutive days (Visits 11 and 12, Days 60 and 61). Approximately 3 weeks after
Visit 12 (Day 61), the subjects will again be in the EEC for 4 consecutive days (Visits
13-16, Days 82-85).
During all EEC visits, the subjects will be exposed to ragweed pollen at an average
concentration of 3500 ± 500 pollen grains per cubic meter. Each EEC visit will last 4 hours.
During each EEC visit, patients will be asked to record symptom scores for nasal and
non-nasal symptoms at scheduled time points.
The total duration of a subject's participation in this study is expected to be a minimum of
85 days.
Ragweed allergy is the most common seasonal allergy in North America. Allergen immunotherapy
is a therapeutic option for patients who have allergy symptoms that cannot be adequately
controlled by avoidance of the allergen or medication. It may also be appropriate for those
who cannot tolerate their medications due to side effects or have difficulties with
medication compliance.
This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter
study. After passing the initial Screening Visit, subjects will be in the environmental
exposure chamber(EEC), a room with a controlled amount of ragweed pollen, for 4 hours each
day on 4 consecutive days. At the last visit, subjects who have achieved a minimum Total
Nasal Symptom Score (TNSS) will be randomized to receive either TOLAMBA or placebo
treatments. Subjects will receive 6 weekly subcutaneous (under the skin) injections of the
study drug. About three weeks after the last injection, subjects will be asked to be in the
EEC for 2 consecutive days (Visits 11 and 12, Days 60 and 61). Approximately 3 weeks after
Visit 12 (Day 61), the subjects will again be in the EEC for 4 consecutive days (Visits
13-16, Days 82-85).
During all EEC visits, the subjects will be exposed to ragweed pollen at an average
concentration of 3500 ± 500 pollen grains per cubic meter. Each EEC visit will last 4 hours.
During each EEC visit, patients will be asked to record symptom scores for nasal and
non-nasal symptoms at scheduled time points.
The total duration of a subject's participation in this study is expected to be a minimum of
85 days.
Comparison: Allergy symptoms of subjects treated with TOLAMBA™ compared with subjects treated
with placebo.
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