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

Primary Purpose

Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Home-based test
Skin test
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypersensitivity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University Hospital Zurich

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Home-based test and skin test

Arm Description

Outcomes

Primary Outcome Measures

Organ specific symptom sum score of HypoScore measured after petting the cat at baseline versus week 24
Organ specific symtpom score component of HypoScore is measured with a questionnaire before and after the participants perform the tests with their cats (petting the cat until certain symptoms are reached).
General weekly symptom score measured at baseline (with unimmunized cat) versus week 24 (with immunized cat)
General weekly symptom score is measured with a weekly questionnaire. This questionnaire will be filled in on a weekly Basis.

Secondary Outcome Measures

Full Information

First Posted
March 17, 2017
Last Updated
March 19, 2018
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT03089788
Brief Title
Methodological Study to Compare the Effect of Different Methods of Measuring Cat Allergy Symptoms in Patients That Have Immunized Their Cats With FEL-CMV.
Official Title
Methodological Study to Compare the Effect of Different Methods of Measuring Cat Allergy Symptoms in Patients That Have Immunized Their Cats With FEL-CMV.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
February 13, 2018 (Actual)
Study Completion Date
March 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersensitivity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home-based test and skin test
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Home-based test
Intervention Description
Home-based tests in which the participant pets his/her cat until he/she reaches a certain symptom strength.
Intervention Type
Other
Intervention Name(s)
Skin test
Intervention Description
Skin Prick Tests will be performed with registered cat allergen extract.
Primary Outcome Measure Information:
Title
Organ specific symptom sum score of HypoScore measured after petting the cat at baseline versus week 24
Description
Organ specific symtpom score component of HypoScore is measured with a questionnaire before and after the participants perform the tests with their cats (petting the cat until certain symptoms are reached).
Time Frame
Comparison of the symptom score of 3 baseline measurements and measurement in week 24
Title
General weekly symptom score measured at baseline (with unimmunized cat) versus week 24 (with immunized cat)
Description
General weekly symptom score is measured with a weekly questionnaire. This questionnaire will be filled in on a weekly Basis.
Time Frame
Measured over 25 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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