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| Name | Class |
|---|---|
| Immune Tolerance Network (ITN) | NETWORK |
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This is a pilot trial in cat allergic participants, designed to compare allergic responses in each participant to a specific allergen by two methods of exposure. The methods of exposure to be used are: the environment exposure chamber (EEC) and nasal allergen challenge (NAC). Potential participants will be screened for evidence of cat allergy.
Participants with a range of allergic sensitivities to cat allergen will be enrolled. To help ensure some breadth in the level of allergic sensitivity among participants, individuals with both high and low exposures to cat allergens in their daily lives will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAC Followed by EEC | Experimental | This arm will undergo allergy assessment first by NAC. After a rest and washout period, the same individuals will undergo assessment in an EEC. |
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| EEC Followed by NAC | Experimental | This arm will undergo allergy assessment first in an EEC. After a rest and washout period, the same individuals will undergo assessment by NAC. |
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| Dose-finding Phase | Experimental | An initial group of 6 to 12 participants with cat allergy as defined by the eligibility criteria will undergo a single-visit, stepwise dose-escalating nasal allergen challenge only, with the aim of estimating the most appropriate single dose of allergen to use in the randomized phase. Eligible participants who participate in the dose-finding phase may proceed to the randomized phase of the trial after a minimum 28-day washout period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal Allergen Challenge | Procedure | Cat allergen (FelD1) applied directly to the nasal tissues |
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| Measure | Description | Time Frame |
|---|---|---|
| NAC Total Nasal Symptom Score (TNSS) Area under the Curve (AUC) | TNSS AUC evaluated from hour 0 to hour 3 of the NAC | Hour 0 to Hour 3 of Day 1 (for "NAC first" arm) or Day 30 (for "EEC first" arm) |
| EEC TNSS AUC | TNSS AUC evaluated from hour 0 to hour 3 of the EEC | Hour 0 to Hour 3 of Day 2 (for "EEC first" arm) or Day 30 (for "NAC first" arm) |
| Measure | Description | Time Frame |
|---|---|---|
| TNSS AUC with NAC | Hour 0 to Hour 2 | |
| TNSS AUC with EEC | Recorded on second day of EEC. | Hour 1 to Hour 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Durham, MD | Imperial College London | Study Chair |
| Piyush Patel, MD | Inflamax Research Incorporated | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inflamax Research Inc. | Mississauga | Ontario | L4W 1A4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21848757 | Background | Walker SM, Durham SR, Till SJ, Roberts G, Corrigan CJ, Leech SC, Krishna MT, Rajakulasingham RK, Williams A, Chantrell J, Dixon L, Frew AJ, Nasser SM; British Society for Allergy and Clinical Immunology. Immunotherapy for allergic rhinitis. Clin Exp Allergy. 2011 Sep;41(9):1177-200. doi: 10.1111/j.1365-2222.2011.03794.x. |
| Label | URL |
|---|---|
| Division of Allergy, Immunology, and Transplantation (DAIT) website | View source |
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| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Environmental Exposure Chamber | Other | The mobile EEC (mEEC) is a movable facility, designed with clean-room technology, used to expose subjects to aeroallergens (in this trial, the allergen FelD1 from cats) at controlled, consistent airborne levels, similar to that experienced in subjects' daily lives. |
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| Cat allergen (FelD1) | Biological |
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| Peak TNSS Score |
Peak TNSS score during NAC and EEC. |
| Hour 0 to Hour 8 |
| National Institute of Allergy and Infectious Diseases (NIAID) website | View source |
| Immune Tolerance Network (ITN) website | View source |