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

Sponsor

Red Maple Trials Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03414801

Collaborator

Ottawa Allergy Research Corporation (Other)

Enrollment

Location

Arms

5.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis Rhinoconjunctivitis Exposure	Other: Allergen Exposure	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 6, 2018

Actual Primary Completion Date :

Apr 15, 2018

Actual Study Completion Date :

Jul 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cohort 1 Cat Allergic Subjects	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. Other Names: Environmental Exposure
Active Comparator: Cohort 2 Non-Allergic Subjects will	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. Other Names: Environmental Exposure

Arm

Intervention/Treatment

Active Comparator: Cohort 1

Cat Allergic Subjects

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.

Other Names:

Environmental Exposure

Active Comparator: Cohort 2

Non-Allergic Subjects will

Other: Allergen Exposure

Other Names:

Environmental Exposure

Outcome Measures

Primary Outcome Measures

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

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]
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 Total Rhinoconjunctivitis Symptom Score (TRCSS) at individual time points on the two exposure days [15 weeks]
Sum of TNSS and TOSS
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria for Allergic Subjects:

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

Exclusion Criteria for Allergic Subjects:

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
Subjects with significant renal or hepatic impairment at screening
Subjects with scheduled elective surgery or other procedures requiring general anaesthesia during the study
Subjects with any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the outcomes of the study, or the participant's ability to participate in the study
Subjects who have participated in another research study involving an investigational product within 30 days or 5 half-lives prior to the screening visit
Subjects who are using unacceptable concomitant medications within the washout period prior to the screening visit (see Table 7.2-1)
Subjects with a history of alcohol or drug abuse within the previous 5 years
Subjects with known HIV or hepatitis B or C positivity
Subjects who for any reason would be unlikely to comply with the study requirements

Inclusion Criteria for non allergic subjects:

Healthy male and female adults, 18 years to 65 years of age
Willing and able to give informed consent for participation in the study.
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

Exclusion Criteria for non allergic subjects:

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
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 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
Subjects with significant renal or hepatic impairment at screening
Subjects with scheduled elective surgery or other procedures requiring general anaesthesia during the study
Subjects with any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the outcomes of the study, or the participant's ability to participate in the study
Subjects who have participated in another research study involving an investigational product within 30 days or 5 half-lives prior to the screening visit
Subjects who are using unacceptable concomitant medications within the washout period prior to the screening visit (see Table 7.2-1)
Subjects with a history of alcohol or drug abuse within the previous 5 years
Subjects with known HIV or hepatitis B or C positivity
Subjects who for any reason would be unlikely to comply with the study requirements