drugset / Trial / NCT02543346

Comparability and Standardization of Controlled Allergen Challenge Facilities

NCT02543346

RandomizedCrossoverDouble-blindOther

Summary

Allergen challenge facilities have been utilized for many years in clinical drug trials studying onset of action, proof of concept, duration of action, and efficacy. Each facility has somewhat different design characteristics and pollen dispersal technologies. Facilities are located in disparate geographic areas and have populations of participants who are sensitized to allergens unique to that area. Therefore, facilities have operated as single sites with little effort to evaluate facility comparability or to attempt standardization across facilities. The purpose of this study is to compare the two sites and assess whether the sites are able to achieve similar symptom scores.

Timeline

Start
2015-10
Primary completion
2016-02
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetirizine Other / unclassified 10 mg Oral

Indications