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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03097094
Other study ID # Dog allergy
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 24, 2017
Est. completion date January 9, 2019

Study information

Verified date November 2022
Source Copenhagen Studies on Asthma in Childhood
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date January 9, 2019
Est. primary completion date September 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Male dog
Male dog extract
Female dog
Female dog extract

Locations

Country Name City State
Denmark Copsac, Dbac Gentofte Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Copenhagen Studies on Asthma in Childhood

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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