Red Maple Trials Cat Allergen Natural Exposure Chamber Validation in Cat-allergic Subjects

Not Applicable

Completed

• Conditions: Rhinoconjunctivitis; Allergic Rhinitis; Exposure
• Interventions: Other: Allergen Exposure

• Registration Number: NCT03414801
• Lead Sponsor: Red Maple Trials Inc.

Brief Summary

To assess the reproducibility of the allergic response in the cat allergic subjects, measured as the change from baseline of the Total Nasal Symptom Score (TNSS) on the two challenge days.

Detailed Description

To validate the Red Maple Trials Natural Exposure Chamber for cat exposure studies in non-asthmatic subjects with perennial allergic rhinitis and allergy to cat dander by examining the reproducibility of the response on two allergen challenge days and comparing the response of allergic to non-allergic subjects.

Study Timeline

• Study First Submitted: 2018-01-18
• Study First Submitted QC: 2018-01-26
• Study First Posted: 2018-01-30
• Study Start: 2018-02-06
• Status Verified: 2018-04
• Primary Completion: 2018-04-15
• Study Completion: 2018-07-30
• Last Update Submitted: 2018-08-23
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2	Allergen Exposure	Non-Allergic Subjects will
Cohort 1	Allergen Exposure	Cat Allergic Subjects

Primary Outcome Measures

Name	Time	Method
Difference in Total Nasal Symptom Score (TNSS) change from baseline to the end of the challenge between the two challenge days (Visits 2 and 3) in the cat-allergic subjects	15 weeks	Runny nose, sneezing, blocked nose, itchy nose

Secondary Outcome Measures

Name	Time	Method
Comparison of TNSS at individual time points on the two exposure days	15 weeks	Runny nose, sneezing, blocked nose, itchy nose
Comparison of Total Respiratory Symptom Score (TRSS) at individual time points on the two exposure days	15 weeks	Wheezing, shortness of breath, coughing
Comparison of the exposure times of allergic compared to non-allergic subjects	15 weeks
Difference in exposure time between the two exposure days for all subjects	15 weeks
Comparison of Total Ocular Symptom Score (TOSS) at individual time points on the two exposure days	15 weeks	Itchy eyes and watery eyes
Comparison of Fel d1 levels during the exposures	15 weeks
TNSS change from baseline to the end of the challenge of allergic subjects to non-allergic subjects	15 weeks
Comparison of Total Rhinoconjunctivitis Symptom Score (TRCSS) at individual time points on the two exposure days	15 weeks	Sum of TNSS and TOSS

Trial Locations

Locations (1)

Ottawa Allergy Research Corporation; 🇨🇦 Ottawa, Ontario, Canada