Patients with ragweed pollen allergy
Conditions
Interventions
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: O
Sponsors
Curalogic A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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, who are sexually active, they must be consistently using a highly effective method of birth control (oral contraceptive, intra-uterine device [IUD], condom plus spermicide, Depo-Provera or other acceptable contraceptive methods, [abstinence and celibacy will be accepted only with written confirmation by subject]) for at least one month prior to study entry and will continue to use this method consistently for the duration of the study; 8. Are able to understand the protocol and comply with study instructions. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Are pregnant and/or breast feeding; 2. Have a chronic or acute disease that, in the opinion of the Investigator, might interfere with the evaluation of the efficacy or the safety of the study medication or might place the subject at additional risk; 3. Have perennial or structurally related rhinitis, including vasomotor rhinitis, that will interfere with the evaluation of symptoms due to ragweed allergy i.e. require treatment of their allergic symptoms with antihistamines or nasal steroids during the months of December and January; 4. Have a routine sleeping pattern between the hours of approximately 6:00 am to 6:00 pm; 5. Are currently receiving immunotherapy to any allergens and/or have received ragweed immunotherapy within 5 years of the Screening Visit (immunotherapy to other allergens than ragweed discontinued within 90 days of Screening Visit is allowed); 6. Are asthmatic requiring daily “controller” medications (inhaled corticosteroids, cromolyn-type drugs, long-acting bronchodilators, leukotriene antagonists) or use “rescue medicines” (albuterol or similar short-acting bronchodilators) more than 4 times per week at any time during the year or has a FEV1<80% of the predicted value;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the safety of an orally administered MRPE, 40 Amb a 1 units daily, and placebo during a 1year treatment period;Secondary Objective: to evaluate the treatment effect of MRPE on serum immuniglobulin levels;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. | — |
Countries
Hungary
Outcome results
None listed