Comparability and Standardization of Controlled Allergen Challenge Facilities

NCT02543346 | Completed Phase 4 Results

• 1 other identifier: EEU-BRC-001
• Study Type: interventional
• Target: 98
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Comparison of TRSS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.

  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/symptom clearly present, but minimal awareness; easily tolerated), 2 (Moderate: Definite awareness of sign/symptom that is bothersome, but tolerable), 3 (Severe: Sign/symptom that is hard to tolerate; causes interference with activities during the challenge session. A higher score indicates higher symptom severity.

  First treatment visit and second treatment visit.

Secondary Outcomes (4)

• Comparison of TNSS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.

  First treatment visit and second treatment visit.

• Comparison of TOSS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.

  First treatment visit and second treatment visit.

• Comparison of GRCS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.

  First treatment visit and second treatment visit.

• Comparison of VAS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.

  First treatment visit and second treatment visit.

Study Arms (2)

cetirizine hydrochloride

OTHER

Drug: Cetirizine

placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Cetirizine DRUG

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

Also known as: Zyrtec, Reactine

cetirizine hydrochloride

Placebo OTHER

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

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• history of rhinoconjunctivitis during ragweed season for a minimum of 2 years, including the previous 2 ragweed seasons.
• positive skin test to ragweed allergen.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University: lead
• Biogenics Research Chamber, LLC: collaborator

Study Sites (2)

Biogenics Research Chamber

San Antonio, Texas, 78229, United States

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Cetirizine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Anne Ellis
• Organization: Kingston General Hospital

ellisa@kgh.kari.net

6135482336

Study Officials

• Anne K Ellis, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Division of Allergy & Immunology

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 7, 2015
• Study Start: October 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: May 1, 2016
• Last Updated: April 9, 2019
• Results First Posted: April 9, 2019

Record last verified: 2019-03

Locations

CA (1); US (1)