Trial Outcomes & Findings for Comparability and Standardization of Controlled Allergen Challenge Facilities (NCT NCT02543346)

Last Updated: 2019-04-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

98 participants

Primary outcome timeframe

First treatment visit and second treatment visit.

Results posted on

2019-04-09

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	EEU: Cetirizine First, Then Placebo 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.	EEU: Placebo First, Then Cetirizine 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.	BRC: Cetirizine First, Then Placebo 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.	BRC: Placebo First, Then Cetirizine 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.
First Priming Visit STARTED	26	25	24	23
First Priming Visit COMPLETED	26	25	24	23
First Priming Visit NOT COMPLETED	0	0	0	0
First Treatment Visit STARTED	26	25	24	23
First Treatment Visit COMPLETED	26	25	24	23
First Treatment Visit NOT COMPLETED	0	0	0	0
Washout (at Least 14 Days) STARTED	26	25	24	23
Washout (at Least 14 Days) COMPLETED	26	25	24	23
Washout (at Least 14 Days) NOT COMPLETED	0	0	0	0
Second Priming Visit STARTED	26	25	24	23
Second Priming Visit COMPLETED	25	23	22	21
Second Priming Visit NOT COMPLETED	1	2	2	2
Second Treatment Visit STARTED	25	23	22	21
Second Treatment Visit COMPLETED	25	23	22	21
Second Treatment Visit NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	EEU: Cetirizine First, Then Placebo 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.	EEU: Placebo First, Then Cetirizine 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.	BRC: Cetirizine First, Then Placebo 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.	BRC: Placebo First, Then Cetirizine 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.
Second Priming Visit Withdrawal by Subject	0	2	2	2
Second Priming Visit Adverse Event	1	0	0	0

Baseline Characteristics

Comparability and Standardization of Controlled Allergen Challenge Facilities