Trial Information

Summary: Ragweed Allergy? Toledo Center for clinical research is seeking volunteers ages 18 to 50 with fall allergies to test an investigational allergy medication.

The purpose of this study is to find out if the use of A Standardized Short Ragweed Pollen Allergenic Extract (Sublingual-Oral Immunotherapy) can help people who have fall allergy symptoms. The study will last until the end of the 2008 ragweed season. It will require about 8 visits to the office. Qualified participants will receive either placebo or study medication. They will also receive rescue medication during the ragweed allergy season.

Patient Inclusion Criteria:

• M/F age 18 - 50
• Ragweed allergy (moderate to severe) for at least two years with or without asthma
• Able to complete and transmit an electronic diary
• Able to remain in pollen area during 2008 ragweed season
• Able and willing to use an Epi-pen

Patient Exclusion Criteria:

• History of anaphylaxis
• Takes antihistamines or nasal steroids greater than twice a week in the months of January/February
• Chronic sinusitis, unstable angina, significant arrhythmia, uncontrolled hypertension, immunological disease that the PI thinks may interfere with the study VMR, DNS, rhinitis medicamentosa, other allergies that confound ragweed season symptoms
• FEV1 less than 80%
• Routine sleeping pattern during the day due to working third shift
• Currently on AI or had ragweed AI within 3 years
• Current user of inhaled, oral, intramuscular, intravenous corticosteroids, Beta-blockers (oral or topical), Tricyclic antidepressants, or MAO inhibitors
• Use of beta agonist more than twice a month unless being taken prior to exercise
• Refusal to sign Epi-pen training form
• Use of medications that can cause gastrointestinal reactions, if subject is using must prove stable with no side effects for at least prior to enrollment
• Travel outside pollen area for more than 2 consecutive weeks during the study
• Positive skin prick to dog or cat and own the pet for which they are allergic
• Significant chronic sinusitis as determined by Dr. Winder
• Xolair within the last 12 months (or other Anti-IgE medications similar to Xolair)

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