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Comparability and Standardization of Controlled Allergen Challenge Facilities

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ClinicalTrials.gov Identifier: NCT02543346
Recruitment Status : Completed
First Posted : September 7, 2015
Results First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Collaborator:
Biogenics Research Chamber, LLC
Information provided by (Responsible Party):
Dr. Anne Ellis, Queen's University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
Condition Allergic Rhinitis
Interventions Drug: Cetirizine
Other: Placebo
Enrollment 98
Recruitment Details A total of 149 individuals were screened across both study sites; 78 individuals were screened at the Environmental Exposure Unit in Kingston, Ontario, Canada. 71 individuals were screened at the Biogenics Research Chamber in San Antonio, Texas, USA.
Pre-assignment Details A total of 98 of 149 individuals were randomized (51 individuals for the Environmental Exposure Unit, 47 individuals for the Biogenics Research Chamber). Of those not randomized, 5 did not meet inclusion criteria, and 46 were discontinued prior to randomization due to not meeting eligibility criteria.
Arm/Group Title EEU: Cetirizine First, Then Placebo EEU: Placebo First, Then Cetirizine BRC: Cetirizine First, Then Placebo BRC: Placebo First, Then Cetirizine
Hide Arm/Group Description At the EEU, participants attended the first priming visit. At least 3 days later, participants attended the first treatment visit (5-h pollen exposure) and received one Cetirizine 10 mg tablet at the 150-min time point. After a washout period of at least 14 days, participants attended the second priming visit. At least 3 days later, participants attended the second treatment visit (5-h pollen exposure) and received one matching placebo tablet at the 150-min time point. At the EEU, participants attended the first priming visit. At least 3 days later, participants attended the first treatment visit (5-h pollen exposure) and received one matching placebo tablet at the 150-min time point. After a washout period of at least 14 days, participants attended the second priming visit. At least 3 days later, participants attended the second treatment visit (5-h pollen exposure) and received one Cetirizine 10 mg tablet at the 150-min time point. At the BRC, participants attended the first priming visit. At least 3 days later, participants attended the first treatment visit (5-h pollen exposure) and received one Cetirizine 10 mg tablet at the 150-min time point. After a washout period of at least 14 days, participants attended the second priming visit. At least 3 days later, participants attended the second treatment visit (5-h pollen exposure) and received one matching placebo tablet at the 150-min time point. At the BRC, participants attended the first priming visit. At least 3 days later, participants attended the first treatment visit (5-h pollen exposure) and received one matching placebo tablet at the 150-min time point. After a washout period of at least 14 days, participants attended the second priming visit. At least 3 days later, participants attended the second treatment visit (5-h pollen exposure) and received one Cetirizine 10 mg tablet at the 150-min time point.
Period Title: First Priming Visit
Started 26 25 24 23
Completed 26 25 24 23
Not Completed 0 0 0 0
Period Title: First Treatment Visit
Started 26 25 24 23
Completed 26 25 24 23
Not Completed 0 0 0 0
Period Title: Washout (at Least 14 Days)
Started 26 25 24 23
Completed 26 25 24 23
Not Completed 0 0 0 0
Period Title: Second Priming Visit
Started 26 25 24 23
Completed 25 23 22 21
Not Completed 1 2 2 2
Reason Not Completed
Withdrawal by Subject             0             2             2             2
Adverse Event             1             0             0             0
Period Title: Second Treatment Visit
Started 25 23 22 21
Completed 25 23 22 21
Not Completed 0 0 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description Includes all participants at the EEU and BRC sites. All participants were randomized to receive both interventions (Cetirizine 10 mg and Placebo).
Overall Number of Baseline Participants 98
Hide Baseline Analysis Population Description
Includes participants at both EEU and BRC sites who were randomized to receive both interventions (Cetirizine 10 mg and Placebo).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants
44.2  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants
Female
57
  58.2%
Male
41
  41.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants
Hispanic or Latino
27
  27.6%
Not Hispanic or Latino
71
  72.4%
1.Primary Outcome
Title Comparison of TRSS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.
Hide Description

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.

Time Frame First treatment visit and second treatment visit.
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses included all randomized participants who received at least 1 dose of study medication (Cetirizine 10 mg or Placebo).
Arm/Group Title EEU Placebo BRC Placebo EEU Cetirizine BRC Cetirizine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 48 43 48 43
Mean (Standard Error)
Unit of Measure: score on a scale
11.9  (0.49) 11.7  (0.51) 11.5  (0.49) 10.8  (0.52)
2.Secondary Outcome
Title Comparison of TNSS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.
Hide Description

Participants recorded their nasal and ocular symptoms at baseline and during the intervention visits.

The Total Nasal Symptom Score (TNSS) is a composite score comprised of 4 nasal (runny nose, sneezing, nasal itch, nasal congestion) symptoms. The severity of each individual symptom is rated on a 4-point scale (0 to 3) and are summed for a maximum TNSS of 12 (0 to 12) .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.

Time Frame First treatment visit and second treatment visit.
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses included all randomized participants who received at least 1 dose of study medication (Cetirizine 10 mg or Placebo).
Arm/Group Title EEU Placebo BRC Placebo EEU Cetirizine BRC Cetirizine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 48 43 48 43
Mean (Standard Error)
Unit of Measure: score on a scale
7.3  (0.30) 7.5  (0.32) 7.1  (0.30) 6.9  (0.32)
3.Secondary Outcome
Title Comparison of TOSS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.
Hide Description

Participants recorded their nasal and ocular symptoms at baseline and during the intervention visits.

The Total Ocular Symptom Score (TOSS) is a composite score comprised of 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 TOSS of 9 (0 to 9) .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.

Time Frame First treatment visit and second treatment visit.
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses included all randomized participants who received at least 1 dose of study medication (Cetirizine 10 mg or Placebo).
Arm/Group Title EEU Placebo BRC Placebo EEU Cetirizine BRC Cetirizine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 47 43 47 43
Mean (Standard Error)
Unit of Measure: score on a scale
4.6  (0.23) 4.2  (0.24) 4.4  (0.23) 3.9  (0.24)
4.Secondary Outcome
Title Comparison of GRCS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.
Hide Description

Participants recorded how they were feeling at baseline and at the end of both treatment visits.

The Global Rating of Change Scale documents the changes in the participant's emotions. The scale ranges from +7 (A very great deal better) to -7 (A very great deal worse) with 0 being no change. A higher score indicates a better outcome.

Time Frame First treatment visit and second treatment visit.
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses included all randomized participants who received at least 1 dose of study medication (Cetirizine 10 mg or Placebo).
Arm/Group Title EEU Placebo BRC Placebo EEU Cetirizine BRC Cetirizine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 48 43 48 43
Mean (Standard Error)
Unit of Measure: score on a scale
1.2  (0.55) -0.1  (0.57) 1.8  (0.55) 0.9  (0.58)
5.Secondary Outcome
Title Comparison of VAS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.
Hide Description

Participants recorded the severity of all nasal and ocular symptoms at baseline and at the end of both treatment visits.

The Visual Analogue Scale (VAS) is a single overall rating of the severity of all nasal and ocular symptoms experienced by the participant. The scale ranges from 0 to 100 mm with 0 mm being no symptoms and 100 mm being the worst symptoms the participant has ever felt.

Time Frame First treatment visit and second treatment visit.
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses included all randomized participants who received at least 1 dose of study medication (Cetirizine 10 mg or Placebo).
Arm/Group Title EEU Placebo BRC Placebo EEU Cetirizine BRC Cetirizine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 48 43 48 43
Mean (Standard Error)
Unit of Measure: units on a scale
52.7  (3.98) 47.7  (4.18) 45.3  (4.00) 44.1  (4.19)
Time Frame Collection of adverse event data started after the first dose of study medication (Cetirizine 10 mg or Placebo) until study completion, a duration of 1 month.
Adverse Event Reporting Description The evaluable population included all participants who were randomized. This includes 51 participants in the EEU and 47 participants in the BRC.
 
Arm/Group Title EEU Placebo BRC Placebo EEU Cetirizine BRC Cetirizine
Hide Arm/Group Description Participants in the EEU who received one matching placebo at either the first or second treatment visit. Participants in the BRC who received one matching placebo at either the first or second treatment visit. Participants in the EEU who received Cetirizine at either the first or second treatment visit. Participants in the BRC who received Cetirizine at either the first or second treatment visit.
All-Cause Mortality
EEU Placebo BRC Placebo EEU Cetirizine BRC Cetirizine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)   0/47 (0.00%)   0/51 (0.00%)   0/47 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
EEU Placebo BRC Placebo EEU Cetirizine BRC Cetirizine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)   0/47 (0.00%)   0/51 (0.00%)   0/47 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
EEU Placebo BRC Placebo EEU Cetirizine BRC Cetirizine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)   0/47 (0.00%)   0/51 (0.00%)   0/47 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Anne Ellis
Organization: Kingston General Hospital
Phone: 6135482336
EMail: ellisa@kgh.kari.net
Layout table for additonal information
Responsible Party: Dr. Anne Ellis, Queen's University
ClinicalTrials.gov Identifier: NCT02543346     History of Changes
Other Study ID Numbers: EEU-BRC-001
First Submitted: September 2, 2015
First Posted: September 7, 2015
Results First Submitted: March 6, 2018
Results First Posted: April 9, 2019
Last Update Posted: April 9, 2019