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NCT02543346 · ClinicalTrials.gov registry record · Phase 4

Comparability and Standardization of Controlled Allergen Challenge Facilities

A Phase 4 study of Allergic Rhinitis, sponsored by Queen's University.

Completed
Registry status
Phase 4
Development phase
98
Enrollment target
2
Study locations

NCT02543346: Completed Phase 4 study of Allergic Rhinitis, sponsored by Queen's University.

NCT02543346 is a Phase 4 study of Allergic Rhinitis that has completed, run by Queen's University. The registered enrollment target is 98 participants, roughly in line with the 101-participant average among 23 other Allergic Rhinitis trials with a reported enrollment target. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02543346, a Phase 4 study of Allergic Rhinitis, has completed, sponsored by Queen's University.

COMPLETED
Registry status
Phase 4
Development phase
98 participants
Enrollment target
2
Study locations

Study 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.

Primary Outcome

Participants recorded their nasal and ocular symptoms at baseline and during the intervention visits. The TRSS is a composite score comprised of 4 nasal (runny nose, sneezing, nasal itch, nasal congestion) and 3 ocular (itchy eyes, watery eyes, red/burning eyes) symptoms. The severity of each individual symptom is rated on a 4-point scale (0 to 3) and are summed for a maximum TRSS of 21 (0 to 21).The 4-point scale includes a severity score of 0 (None: no sign/symptom is evident), 1 (Mild: Sign/

Conditions Studied

Interventions

  • OTHER Placebo
  • DRUG Cetirizine

Study Locations (2)

Texas

  • Biogenics Research Chamber - San Antonio

Ontario

  • Kingston General Hospital - Kingston

Trial Details

FieldValue
Enrollment Target 98 participants
Start Date 2015-10
Est. Completion 2016-05
Phase Phase 4
Queen's University

1 total trials

What the finished NCT02543346 record still lists

NCT02543346 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, roughly in line with the 101-participant average among 23 other Allergic Rhinitis trials with a reported enrollment target.

The record links to 1 condition, with Allergic Rhinitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02543346 reports a single indexed study location in Texas, Ontario.

Frequently Asked Questions

What is clinical trial NCT02543346 about?

NCT02543346 is a clinical study titled "Comparability and Standardization of Controlled Allergen Challenge Facilities". 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 geo...

What is the current status of trial NCT02543346?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 98 participants. The study started on 2015-10. Estimated completion is 2016-05.

What conditions does trial NCT02543346 study?

This clinical trial studies the following conditions: Allergic Rhinitis.

What interventions are being tested in trial NCT02543346?

The interventions under investigation include: Placebo (OTHER), Cetirizine (DRUG).

Who is sponsoring clinical trial NCT02543346?

This trial is sponsored by Queen's University, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02543346 being conducted?

This trial has 2 study locations across Texas, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Allergic Rhinitis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02543346's enrollment target sits among peer trials

98 7th of 23 higher than 17 of 23 other Allergic Rhinitis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Allergic Rhinitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02543346, the US trial registry maintained by the National Library of Medicine. NCT02543346 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.