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Precision Allergy: Separate Allergies to Male and Female Dogs

Primary Purpose

Allergy; Dander

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Male dog
Female dog
Sponsored by
Copenhagen Studies on Asthma in Childhood
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Allergy; Dander focused on measuring Dog allergy, Can f 5, Male dog, Female dog, Allergen components

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Copsac, Dbac

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Male dog

Female dog

Arm Description

Male dog extract used for skin prick test and conjunctival provocation

Female dog extract used for skin prick test and conjunctival provocation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 24, 2017
Last Updated
November 14, 2022
Sponsor
Copenhagen Studies on Asthma in Childhood
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1. Study Identification

Unique Protocol Identification Number
NCT03097094
Brief Title
Precision Allergy: Separate Allergies to Male and Female Dogs
Official Title
Precision Allergy: Separate Allergies to Male and Female Dogs
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 24, 2017 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
January 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Copenhagen Studies on Asthma in Childhood

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy; Dander
Keywords
Dog allergy, Can f 5, Male dog, Female dog, Allergen components

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Male dog
Arm Type
Active Comparator
Arm Description
Male dog extract used for skin prick test and conjunctival provocation
Arm Title
Female dog
Arm Type
Active Comparator
Arm Description
Female dog extract used for skin prick test and conjunctival provocation
Intervention Type
Diagnostic Test
Intervention Name(s)
Male dog
Intervention Description
Male dog extract
Intervention Type
Diagnostic Test
Intervention Name(s)
Female dog
Intervention Description
Female dog extract
Primary Outcome Measure Information:
Title
Male vs. female dog SPT in Can f 5 mono sensitized patients
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Male vs. female dog conjunctival provocation in Can f 5 mono sensitized patients
Description
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.
Time Frame
6 months
Title
Male vs. female dog SPT in dog poly sensitized patients
Description
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.
Time Frame
6 months
Title
Male vs. female dog conjunctival provocation in dog poly sensitized patients
Description
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.
Time Frame
6 months
Title
Can f 5 vs. SPT size
Description
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.
Time Frame
6 months
Title
Can f 5 vs. conjunctival provocation
Description
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.
Time Frame
6 months
Title
SPT vs. conjunctival provocation
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Bønnelykke, MD, PhD
Organizational Affiliation
Copenhagen Studies on Asthma in Childhood
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copsac, Dbac
City
Gentofte
State/Province
Copenhagen
ZIP/Postal Code
2820
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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Precision Allergy: Separate Allergies to Male and Female Dogs

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