Methodological Study to Compare the Effect of Different Methods of Measuring Cat Allergy Symptoms in Patients That Have Immunized Their Cats With FEL-CMV.

NCT ID: NCT03089788

Last Updated: 2018-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-30

Study Completion Date

2018-03-19

Brief Summary

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In this Project we will monitor the symptoms of cat allergic participants who live together with a cat which is immunized with FEL-CMV using the novel symptom recording method "HypoScore", a General weekly symptom score, and a skin prick test before and after immunization of the cat. This project may enable us to determine if the scoring System and the tests are able to detect a difference in participant symptoms before and after immunization of the cats.

Detailed Description

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Conditions

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Hypersensitivity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Home-based test and skin test

Group Type OTHER

Home-based test

Intervention Type OTHER

Home-based tests in which the participant pets his/her cat until he/she reaches a certain symptom strength.

Skin test

Intervention Type OTHER

Skin Prick Tests will be performed with registered cat allergen extract.

Interventions

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Home-based test

Home-based tests in which the participant pets his/her cat until he/she reaches a certain symptom strength.

Intervention Type OTHER

Skin test

Skin Prick Tests will be performed with registered cat allergen extract.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent after participants' information
* 18 to 65 years, male or female
* Participant understands the nature, meaning and scope of the study
* Positive screening prick test (wheal diameter ≥ 3mm) to Histamine dihydrochloride 10mg/ml
* Positive screening prick test (mean wheal diameter ≥ 3 mm) when tested with already standardized cat allergen extract
* Positive screening scratch test when tested with cat dander sample of participant's cat.
* Living with a cat in the same household and parallel participation in the cat study in which the cat will be immunized
* A positive clinical history with inhalant allergy presumably due to cat allergen

Exclusion Criteria

* Immunosuppression or haematological diseases, in particular anaemias or leukaemia
* Other previous or current condition or participation in clinical trials influencing the results of the present study by discretion of the investigator
* Incapable of understanding the nature, meaning or scope of the research project or incapable of giving written informed consent
* Unwilling or incapable of following the study procedures, e.g. due to language problems, psychological disorders, dementia, known or suspected drug or alcohol abuse etc.
* Women who are pregnant or breast feeding or having the intention to become pregnant during the course of the study
* Positive skin reaction in the screening prick test to negative control
* History of anaphylactic reaction to pet allergens
* Severe diseases influencing the results of the present study by discretion of the investigator
* Immunotherapy with Fel d 1 / cat allergen preparation during the past two years.
* Skin lesions and excessive hair growth in the skin test areas
* Treatment with prohibited concomitant medications with the exception of medications with local effects which will not influence the results of the skin tests and the results of the other tests (testing period)
* The participant should not suffer from other respiratory allergies during this study (people who suffer from asthma are not excluded)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Thomas Kuendig

Prof. Dr. med

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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ZU-HypoCat-002

Identifier Type: -

Identifier Source: org_study_id

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