Efficacy and Safety Study Of Short Ragweed Pollen Sublingual-Oral Immunotherapy

Randomized, Double-Blind, Placebo-Controlled, Parallel Group Efficacy And Safety Trial Of Sublingual-Oral Immunotherapy (SLIT) In Adults With Allergic Rhinoconjunctivitis Caused By Ragweed Pollen

The primary objective of this study is to demonstrate that SLIT administered pre-and co-seasonally is effective in reducing rhinoconjunctivitis symptoms during the entire short ragweed pollen season.

Inclusion Criteria:

• allergic to ragweed

Exclusion Criteria:

• not allergic to ragweed
• history of anaphylaxis
• subject with chronic sinusitis, unstable angina, significant arrhythmia, uncontrolled hypertension, or other chronic or immunological disease
• Asthmatic subjects with FEV1 or PEF less than or equal to 80% predicted
• Subjects who have received experimental drug within 30 days prior to study admission
• Subjects who have received anit-IgE medications in the last 12 months
• Subjects who have received ragweed immunotherapy in the last 3 years
• Subjects who are currently users of inhaled, intramuscular, or intravenous corticosteroids, tricyclic anti-depressants, beta blockers, and MAO inhibitors
• Subjects refusing to sign epi-pen training form
• Females who are pregnant or breast feeding