A randomized doble-blind placebo-controlled study to assess the safety in a one-year of orally administered microencapsulated ragweed pollen extract

INTERVENTION: Product Name: Microencapsulated ragweed pollen extract Product Code: MRPE Pharmaceutical Form: Capsule, soft Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use CONDITION: Patients with ragweed pollen allergy PRIMARY OUTCOME: Main Objective: to evaluate the safety of an orally administered MRPE, 40 Amb a 1 units daily, and placebo during a 1year treatment period Primary end point(s): To evaluate the safety of an orally administered MRPE, 40 Amb a 1 units daily, and placebo during a 1‐year treatment period. Secondary Objective: to evaluate the treatment effect of MRPE on serum immuniglobulin levels INCLUSION CRITERIA: Subjects eligible for enrollment into this study are female and males who: 1. Are between 18 and 65 years of age and are in general good health; 2. Have a history of two consecutive seasons of fall, seasonal allergic rhinitis that has required repeated treatment with antihistamines, leukotriene antagonists, and/or nasal steroids; 3. Have a positive puncture skin test to a standardized ragweed (Ambrosia artemisiifolia) pollen extract (= 150 Amb a 1 units/ml) with a:·SE (Sum of erythema) of at least 40 mm, and·Diameter of wheal of at least 5 mm; 4. Have a ragweed (Ambrosia artemisiifolia) specific IgE level of at least 0.70 kU/L using the Pharmacia & Upjohn ImmunoCAP assay; 5. Are willing to remain in the study center’s defined ragweed area for the entire pollen season; 6. Will be available for clinic visits for the duration of the study; 7. Have a negative urine pregnancy test (women of childbearing potential). In women of childbearing age,