A STUDY FOR RAGWEED POLLEN ALLERGY IN PATIENTS AT LEAST 50 YEARS OLD

PURPOSE OF THE STUDY: Allergen specific immunotherapy, in which an allergen is administered to an allergic patient in order to bring about systemic immunological tolerance to the natural allergen, is a well-accepted approach to treating allergic patients. Subcutaneous (under the skin) allergen injections have been the main method of delivery of this type of immunotherapy for many years. Researchers now wish to evaluate the safety of an investigational sublingual (under the tongue) tablet to deliver allergen specific immunotherapy. Study subjects for this clinical trial will be 50 years of age or older who have had rhinoconjunctivitis (hay fever) caused by ragweed pollen for at least 2 years.

INVESTIGATIONAL STUDY DRUG: The investigational study drug contains a ragweed extract in a freeze-dried tablet convenient for under the tongue (sublingual) administration.

STUDY INFORMATION:

• Study subjects who continue to qualify after a brief screening process will receive investigational study medication or placebo (an inactive substance) in a doule-blinded manner (neither the study subject nor the staff at the research site will know which treatment has been assigned). Chance of receiving placebo is 1 in 3. The investigational study medication or placebo will be taken once daily for 28 days.

• An EpiPen® will be provided for use in case of an allergic reaction.

• Study procedures include physical exams, labwork, electrocardiogram, pulmonary function tests and allergy testing.

• There is no charge for participation.

• A stipend will be provided to study participants for study related time and/or travel in the amount of $50 each for Visits 1 & 5 and $35 each for Visits 2, 3 & 4 for a total possible of $205. NOTE: There is no stipend for a pre-study visit, if such a visit is scheduled, or for telephone visits.

• Investigator: Jeffrey Rumbyrt, M.D. of Denver Allergy & Asthma Associates

INCLUSION/EXCLUSION CRITERIA (Partial List):

• Male or female, at least 50 years of age

• Must have a history of allergy to ragweed during the past 2 years

• Females who have the potential to become pregnant must be willing to use an acceptable method of birth control during the study

• For other inclusion/exclusion criteria information, please talk with a study coordinator

Study Coordinators: Mary Reid, Jodi Frazier, Cheri Casey, or Dara Stillman

Western States Clinical Research, Inc., 9201 W. 44th Avenue, Wheat Ridge, CO 80033

Phone: 303-940-0909 (This is a message line; we will return your call within 24 hours.), FAX: 303-940-0308

E-mail: research@wscrinc.com

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Our mission is to promote the health and well-being of humanity by the development of new medicines through high-quality clinical research and a closely held philosophy of striving for excellence.

To find out about the studies that are currently underway at our office, please see Clinical Trials.

Western States Clinical Research Inc. specializes in research studies related to gastroenterology, asthma and allergy, pulmonology, internal medicine, ophthalmology and dermatology. Our website contains information for physicians, pharmaceutical companies and individuals interested in participating in clinical research.

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