drugset / Trial / NCT00247520

Safety and Efficacy Study of rEV131 in Allergic Rhinitis

NCT00247520 ↗

Phase 1/2 Unknown 112 enrolled Evolutec Group
RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to see whether rEV131 when given as a nasal spray in a single dose to each nostril is safe and can reduce the signs and symptoms of allergic rhinitis (hay fever) caused by an allergen challenge. All patients enrolled will be known to be allergic to ragweed pollen and will be given ragweed pollen extract in both nostrils 30 minutes after either rEV131 or innactive vehicle (placebo). The signs and symptoms (sneezing, itching, stuffiness and runny nose) will each be given a score from 0 to 3 by the patient and these will be added together and the combined scores from patients treated with rEV131 will be compared with those who received placebo.

Timeline

Start
2005-05
Primary completion
—
Completion
2005-08

Drugs

EvaluationDrugModalityDoseRoute
Subject VOTUCALIS Protein / enzyme biologic 0.63 mg/ml Intranasal
Subject VOTUCALIS Protein / enzyme biologic 1.25 mg/ml Intranasal
Subject VOTUCALIS Protein / enzyme biologic 2.5 mg/ml Intranasal
Subject VOTUCALIS Protein / enzyme biologic 5 mg/ml Intranasal