Precision Allergy: Separate Allergies to Male and Female Dogs

Study Overview
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Brief Summary
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A new male-specific dog-allergen-component has been found (Can f 5) which indicates possible differences in allergic reactions to male and female dogs. This has not yet been tested in real life. The aim is to test if sensitization only to the male-dog specific allergen-component, Can f 5, results in a positive skin prick test (SPT) to male dog extract and not female dog extract. In addition, the investigators want to investigate if allergic symptoms only occur when exposed to the male dog extract by conjunctival provocation.

Official Title
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Precision Allergy: Separate Allergies to Male and Female Dogs

Conditions
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Allergy; Dander

Intervention / Treatment
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* Diagnostic Test: Male dog
* Diagnostic Test: Female dog


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants in the COPSAC 2000 cohort Positive component test (>0.3 ISU) to Can f 1, Can f 2, Can f 3 or Can f 5 Exclusion Criteria: Uncontrolled asthma Eye-surgery within the past 6 months Antihistamine allergy and others

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Male dog<br>Male dog extract used for skin prick test and conjunctival provocation | Diagnostic Test: Male dog<br>* Male dog extract<br>|
| Active Comparator: Female dog<br>Female dog extract used for skin prick test and conjunctival provocation | Diagnostic Test: Female dog<br>* Female dog extract<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Male vs. female dog SPT in Can f 5 mono sensitized patients | In the patients that have a positive SPT (> 2mm) to dog and are monosensitized to the Can f 5 component, the investigatiors want to compare the reaction to SPT (pos/neg) to male vs. female dog extract in the same patient using logistic regression analysis with mixed effects to account for repeated measures. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Male vs. female dog conjunctival provocation in Can f 5 mono sensitized patients | In the patients that have a positive SPT (> 2mm) to dog and are monosensitized to the Can f 5 component, the investigatiors want to compare the reaction to conjunctival provocation (positive/negative) to male vs. female dog extract in the same patient using logistic regression analysis with mixed effects to account for repeated measures. | 6 months | 
| Male vs. female dog SPT in dog poly sensitized patients | In the patients that have a positive SPT (> 2mm) to dog and are sensitized to the Can f 1, 2 and/or 3 component, the investigatiors want to compare the reaction to SPT (pos/neg) to male vs. female dog extract in the same patient using logistic regression analysis with mixed effects to account for repeated measures. | 6 months | 
| Male vs. female dog conjunctival provocation in dog poly sensitized patients | In the patients that have a positive SPT (> 2mm) to dog and are sensitized to the Can f 1, 2 and/or 3 component, the investigatiors want to compare the reaction to conjunctival provocation (pos/neg) to male vs. female dog extract in the same patient using logistic regression analysis with mixed effects to account for repeated measures. | 6 months | 
| Can f 5 vs. SPT size | To investigate the correlation between specific Immunoglobulin E (sIgE) level to the Can f 5 component and the SPT wheal size to the male dog extract using a general linear model. | 6 months | 
| Can f 5 vs. conjunctival provocation | To investigate the correlation between sIgE level to the Can f 5 component and the threshold of reaction to the male dog extract at the conjunctival provocation, using a general linear model. | 6 months | 
| SPT vs. conjunctival provocation | To investigate the correlation between SPT wheal size to the male dog extract and the threshold of reaction to the male dog extract at the conjunctival provocation, using a general linear model. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dog allergy, Can f 5, Male dog, Female dog, Allergen components