Phase 4
N=98
Comparability and Standardization of Controlled Allergen Challenge Facilities
Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT02543346 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Comparison of TRSS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups. — 11.9; 11.7; 11.5; 10.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cetirizine (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Queen's University
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of TRSS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups. |
11.9; 11.7; 11.5; 10.8 | — |
| SECONDARY Comparison of TNSS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups. |
7.3; 7.5; 7.1; 6.9 | — |
| SECONDARY Comparison of TOSS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups. |
4.6; 4.2; 4.4; 3.9 | — |
| SECONDARY Comparison of GRCS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups. |
1.2; -0.1; 1.8; 0.9 | — |
| SECONDARY Comparison of VAS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups. |
52.7; 47.7; 45.3; 44.1 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02543346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.