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

NCT03414801 | Completed

• 1 other identifier: RMT005
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis; Rhinoconjunctivitis; Exposure

Keywords

Environmental Exposure Unit; Cat Allergen; Rhinitis; Subject Validation

Outcome Measures

Primary Outcomes (1)

• 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

  Runny nose, sneezing, blocked nose, itchy nose

  15 weeks

Secondary Outcomes (8)

• TNSS change from baseline to the end of the challenge of allergic subjects to non-allergic subjects

  15 weeks

• Difference in exposure time between the two exposure days for all subjects

  15 weeks

• Comparison of the exposure times of allergic compared to non-allergic subjects

  15 weeks

• Comparison of TNSS at individual time points on the two exposure days

  15 weeks

• Comparison of Total Respiratory Symptom Score (TRSS) at individual time points on the two exposure days

  15 weeks

Study Arms (2)

Cohort 1

ACTIVE COMPARATOR

Cat Allergic Subjects

Other: Allergen Exposure

Cohort 2

ACTIVE COMPARATOR

Non-Allergic Subjects will

Other: Allergen Exposure

Interventions

Allergen Exposure OTHER

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.

Also known as: Environmental Exposure

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults, 18 years to 65 years of age
• Willing and able to give informed consent for participation in the study.
• Otherwise healthy with a diagnosis of perennial allergic rhinitis and a clinical history of nasal symptoms during exposure to cat in the previous 2 years
• With positive skin prick test reactivity to cat dander. A positive skin prick test is a wheal ≥3 mm larger than the negative control performed at the screening visit or within 6 months of the screening visit provided that complete documentation (specific allergen used for the SPT and the size of the reaction) is available
• Having sufficient rhinoconjunctivitis symptoms (TRCSS score ≥5) during the first cat challenge
• If subjects are taking medications (other than allergy medications), the dosing must be stable for at least 4 weeks prior to study entry
• With laboratory results at the screening visit which, in the opinion of the investigator, are clinically acceptable for the subject to be enrolled in the study
• Able (in the investigators opinion) and willing to comply with all study requirements

You may not qualify if:

• Subjects with a cat at home or who are regularly exposed to cats during the study period
• Subjects with a diagnosis of asthma with the exception of mild intermittent asthma defined as normal lung function and intermittent treatment with a short-acting beta agonist only
• Subjects with a history of anaphylactic reactions defined as previous or current presentation with two or more of the following:
• Involvement of the skin or mucosa
• respiratory difficulties
• low blood pressure
• gastrointestinal symptoms
• Subjects who have undergone allergen desensitization for cat allergy within the last 2 years
• Subjects with structural nasal defects or nasal polyps
• Subjects with a positive skin-prick test reaction to house dust mite
• Subjects having an infection of the upper airways within 2 weeks prior to the screening visit.
• Subjects who develop an upper respiratory tract infection during the study will be discontinued
• Subjects who have received treatment with Xolair or immunosuppressants during the 4 months prior to the screening visit
• Subjects who wear contact lenses will not be permitted to wear them during the challenge sessions
• Female subjects who are pregnant or lactating at screening or who are planning pregnancy during the course of the study

Sponsors & Collaborators

• Red Maple Trials Inc.: lead
• Ottawa Allergy Research Corporation: collaborator

Study Sites (1)

Ottawa Allergy Research Corporation

Ottawa, Ontario, K1G6C6, Canada

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Rhinitis

Interventions

Environmental Exposure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Environmental Pollution; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: January 30, 2018
• Study Start: February 6, 2018
• Primary Completion: April 15, 2018
• Study Completion: July 30, 2018
• Last Updated: August 24, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)