Precision Allergy: Separate Allergies to Male and Female Dogs

NCT03097094 | Completed

• 1 other identifier: Dog allergy
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergy; Dander

Keywords

Dog allergy; Can f 5; Male dog; Female dog; Allergen components

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  6 months

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

  6 months

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

  6 months

• Can f 5 vs. SPT size

  6 months

• Can f 5 vs. conjunctival provocation

  6 months

Study Arms (2)

Male dog

ACTIVE COMPARATOR

Male dog extract used for skin prick test and conjunctival provocation

Diagnostic Test: Male dog

Female dog

ACTIVE COMPARATOR

Female dog extract used for skin prick test and conjunctival provocation

Diagnostic Test: Female dog

Interventions

Male dog DIAGNOSTIC_TEST

Male dog extract

Male dog

Female dog DIAGNOSTIC_TEST

Female dog extract

Female dog

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Uncontrolled asthma
• Eye-surgery within the past 6 months
• Antihistamine allergy
• and others

Sponsors & Collaborators

• Copenhagen Studies on Asthma in Childhood: lead

Study Sites (1)

Copsac, Dbac

Gentofte Municipality, Copenhagen, 2820, Denmark

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Klaus Bønnelykke, MD, PhD

  Copenhagen Studies on Asthma in Childhood

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: March 31, 2017
• Study Start: March 24, 2017
• Primary Completion: September 1, 2017
• Study Completion: January 9, 2019
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)