A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ORAL MICROENCAPSULATED RAGWEED POLLEN EXTRACT ADMINISTERED PRIOR TO AND DURING THE RAGWEED POLLEN SEASON - RPE 04

Curalogic A/S0 sites550 target enrollmentNovember 23, 2006

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Curalogic A/S
Enrollment: 550
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 23, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Curalogic A/S

Eligibility Criteria

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 (\= 250 Amb a 1 units/ml) with a:
•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\.7 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;

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;
•7\.Have a history of alcohol or drug abuse during the past 18 months;
•8\.Use beta\-blockers and/or monoamine oxidase (MAO) inhibitors;
•9\.Repeated or daily use of proton pump inhibitors within 1 week of the Screening Visit (Pre\-Seasonal Visit 1\) and throughout study;
•10\.Use prohibited medications or have inadequate washout periods prior to the start of the study. The following medications are prohibited and if taken prior to the study, the indicated wash\-out periods are applicable: