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Completed

NCT Number: NCT03097094

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.

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Key information

Conditions

Allergy; Dander Hypersensitivity Immune System Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copsac, Dbac

Gentofte Municipality, Copenhagen, 2820, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Male dog

Diagnostic Test

Male dog extract

Female dog

Diagnostic Test

Female dog extract

Primary outcomes

  1. Male vs. female dog SPT in Can f 5 mono sensitized patients

    Time frame: 6 months

    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 outcomes

  1. Male vs. female dog conjunctival provocation in Can f 5 mono sensitized patients

    Time frame: 6 months

    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.

  2. Male vs. female dog SPT in dog poly sensitized patients

    Time frame: 6 months

    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.

  3. Male vs. female dog conjunctival provocation in dog poly sensitized patients

    Time frame: 6 months

    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.

  4. Can f 5 vs. SPT size

    Time frame: 6 months

    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.

  5. Can f 5 vs. conjunctival provocation

    Time frame: 6 months

    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. SPT vs. conjunctival provocation

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Copenhagen Studies on Asthma in Childhood

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2019
First posted
Mar 31, 2017
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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