An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber
Status:
Completed
Trial end date:
2008-05-01
Target enrollment:
Participant gender:
Summary
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.