Comparability and Standardization of Controlled Allergen Challenge Facilities

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Queen's University
• Collaborator: Biogenics Research Chamber, LLC
• Treatments: Cetirizine

Criteria

Inclusion Criteria:

• history of rhinoconjunctivitis during ragweed season for a minimum of 2 years, including the previous 2 ragweed seasons.

• positive skin test to ragweed allergen.

Exclusion Criteria:

• participant is pregnant, lactating or actively trying to conceive.

• has a history of receiving immunotherapy containing short ragweed within the last 3 years.

• participant has current allergy symptoms.