CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 98 enrolled
Drug / intervention
Cetirizine +1 moredrug
Likely dose
Cetirizine 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02543346
NCT02543346Phase 4Completed

Comparability and Standardization of Controlled Allergen Challenge Facilities

Queen's University·interventional·Posted Sep 7, 2015·Updated Apr 9, 2019

In Brief

A Phase 4 clinical trial evaluating Cetirizine and Placebo for Allergic Rhinitis. Completed, enrolled 98 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 7, 2015
Enrollment StartOct 1, 2015
Primary CompletionFeb 1, 2016
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 10.8 years ago

Interventions

Cetirizinedrug

Participants will receive either cetirizine (10mg tablet, orally) or a placebo (sugar pill) at one of the two treatment visits.

Placeboother

Participants will receive either a placebo or cetirizine (10mg tablet, orally) at one of the two treatment visits