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

Red Maple Trials

Status

Completed

Conditions

Exposure

Rhinoconjunctivitis

Allergic Rhinitis

Treatments

Other: Allergen Exposure

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT03414801

RMT005

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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