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

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.

Study Overview

• Status: Completed
• Conditions: Hypersensitivity
• Intervention / Treatment: Other: Home-based test; Other: Skin test

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Home-based test and skin test	Other: Home-based test; Home-based tests in which the participant pets his/her cat until he/she reaches a certain symptom strength.; Other: Skin test; Skin Prick Tests will be performed with registered cat allergen extract.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Comparison of the symptom score of 3 baseline measurements and measurement in week 24
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.	Measured over 25 weeks

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2017
• Primary Completion (Actual): February 13, 2018
• Study Completion (Actual): March 19, 2018

Study Registration Dates

• First Submitted: March 17, 2017
• First Submitted That Met QC Criteria: March 17, 2017
• First Posted (Actual): March 24, 2017

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: ZU-HypoCat-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No