- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03414801
Red Maple Trials Cat Allergen Natural Exposure Chamber Validation in Cat-allergic Subjects (NEC)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1G6C6
- Ottawa Allergy Research Corporation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cohort 1
Cat Allergic Subjects
|
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:
|
Active Comparator: Cohort 2
Non-Allergic Subjects will
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 15 weeks
|
Runny nose, sneezing, blocked nose, itchy nose
|
15 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TNSS change from baseline to the end of the challenge of allergic subjects to non-allergic subjects
Time Frame: 15 weeks
|
15 weeks
|
|
Difference in exposure time between the two exposure days for all subjects
Time Frame: 15 weeks
|
15 weeks
|
|
Comparison of the exposure times of allergic compared to non-allergic subjects
Time Frame: 15 weeks
|
15 weeks
|
|
Comparison of TNSS at individual time points on the two exposure days
Time Frame: 15 weeks
|
Runny nose, sneezing, blocked nose, itchy nose
|
15 weeks
|
Comparison of Total Respiratory Symptom Score (TRSS) at individual time points on the two exposure days
Time Frame: 15 weeks
|
Wheezing, shortness of breath, coughing
|
15 weeks
|
Comparison of Total Rhinoconjunctivitis Symptom Score (TRCSS) at individual time points on the two exposure days
Time Frame: 15 weeks
|
Sum of TNSS and TOSS
|
15 weeks
|
Comparison of Total Ocular Symptom Score (TOSS) at individual time points on the two exposure days
Time Frame: 15 weeks
|
Itchy eyes and watery eyes
|
15 weeks
|
Comparison of Fel d1 levels during the exposures
Time Frame: 15 weeks
|
15 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RMT005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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