Precision Allergy: Separate Allergies to Male and Female Dogs

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.

Study Overview

• Status: Completed
• Conditions: Allergy; Dander
• Intervention / Treatment: Diagnostic test: Male dog; Diagnostic test: Female dog

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Gentofte, Copenhagen, Denmark, 2820
      • Copsac, DBAC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Male dog; Male dog extract used for skin prick test and conjunctival provocation	Diagnostic test: Male dog; Male dog extract
Active Comparator: Female dog; Female dog extract used for skin prick test and conjunctival provocation	Diagnostic test: Female dog; Female dog extract

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Copenhagen Studies on Asthma in Childhood
• Investigators: Principal Investigator: Klaus Bønnelykke, MD, PhD, Copenhagen Studies on Asthma in Childhood

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2017
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): January 9, 2019

Study Registration Dates

• First Submitted: March 24, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Dog allergy; Can f 5; Male dog; Female dog; Allergen components
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: Dog allergy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No