Phase 4
Completed N=98
Comparability and Standardization of Controlled Allergen Challenge Facilities
Source: ClinicalTrials.gov NCT02543346 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: 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
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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. Informational only — not medical advice.