Trial Information

Summary: Evaluation of using an immunizing extract/vaccine under the tongue rather than by injection for ragweed

Subjects will be screened using a skin prick test and medical histories. This begins a 30 week participation with medical examinations, dosing and completion of patient diaries and notebooks. Enrollment and randomization (like tossing a coin to determine which treatment course each subject will take) follows the screening. Treatment after initial dosing will be daily self-administration in the morning and the e-diary must be maintained with asthma and allergy symptoms and any other required entries by the subject. Visit 7 will be the final visit, about the end of the ragweed season.

Inclusion criteria includes:

• 458 Subjects at 30 sites between 18-55 years old with moderate to severe symptoms of allergy and asthma for at least 2 years before study entry.
• Must show sensitivity to the ragweed allergen.
• Breathing function will be tested; must be 80% or greater.
• Females of child-bearing potential must have a negative urine pregnancy test at the beginning of the study, be using a form of birth control and must notify the study staff if any changes occur in the non-pregnant status.
• Subjects must be planning to remain in the study area for the duration of the trial.

Exclusion criteria includes:

• Subjects taking medications that will be completely discussed, but include nasal steroids, corticosteroids, antidepressants, beta blockers.
• A history of anaphylaxis or persistent asthma, uncontrolled hypertension etc.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.