NCT03414801

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

A Single-Group Study Evaluating Reproducibility of Rhinitis Symptoms Induced by Cat Allergen (Fel d1) Exposure in the Red Maple Trials Natural Exposure Chamber (NEC) ™ in Subjects With Cat Allergy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Red Maple Trials Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Allergic Rhinitis
• Rhinoconjunctivitis
• Exposure

Interventions

Type	Name	Description
OTHER	Allergen Exposure	Subjects will undergo two exposure sessions, one week apart, of up to 1 hour depending on the subject's symptom severity and pulmonary function. During the exposure, subjects will be exposed to cat dander and levels of cat allergen, Fel d1, will be measured using sampling pumps with attached filters.

Timeline

• Start date: 2018-02-06
• Primary completion: 2018-04-15
• Completion: 2018-07-30
• First posted: 2018-01-30
• Last updated: 2018-08-24

Locations

1 site across 1 country: Canada