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| Name | Class |
|---|---|
| Ottawa Allergy Research Corporation | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Active Comparator | Cat Allergic Subjects |
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| Cohort 2 | Active Comparator | Non-Allergic Subjects will |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 | Runny nose, sneezing, blocked nose, itchy nose | 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria for Allergic Subjects:
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:
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:
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:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ottawa Allergy Research Corporation | Ottawa | Ontario | K1G6C6 | Canada |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D004781 | Environmental Exposure |
| ID | Term |
|---|---|
| D004787 | Environmental Pollution |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| 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 | 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 | Wheezing, shortness of breath, coughing | 15 weeks |
| Comparison of Total Rhinoconjunctivitis Symptom Score (TRCSS) at individual time points on the two exposure days | Sum of TNSS and TOSS | 15 weeks |
| Comparison of Total Ocular Symptom Score (TOSS) at individual time points on the two exposure days | Itchy eyes and watery eyes | 15 weeks |
| Comparison of Fel d1 levels during the exposures | 15 weeks |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |