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Trial record 49 of 248 for:    test AND provocation

Precision Allergy: Separate Allergies to Male and Female Dogs

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ClinicalTrials.gov Identifier: NCT03097094
Recruitment Status : Completed
First Posted : March 31, 2017
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Copenhagen Studies on Asthma in Childhood

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.


Condition or disease Intervention/treatment Phase
Allergy; Dander Diagnostic Test: Male dog Diagnostic Test: Female dog Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Precision Allergy: Separate Allergies to Male and Female Dogs
Actual Study Start Date : March 24, 2017
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : January 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03097094


Locations
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Denmark
Copsac, Dbac
Gentofte, Copenhagen, Denmark, 2820
Sponsors and Collaborators
Copenhagen Studies on Asthma in Childhood
Investigators
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Principal Investigator: Hans Bisgaard, MD, DMSc Copenhagen Studies on Asthma in Childhood

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Responsible Party: Copenhagen Studies on Asthma in Childhood
ClinicalTrials.gov Identifier: NCT03097094     History of Changes
Other Study ID Numbers: Dog allergy
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Copenhagen Studies on Asthma in Childhood:
Dog allergy
Can f 5
Male dog
Female dog
Allergen components

Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases