NCT03089788

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

March 30, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2018

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

March 17, 2017

Last Update Submit

March 19, 2018

Conditions

Hypersensitivity

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Home-based test and skin test

OTHER
Other: Home-based testOther: Skin test

Interventions

Home-based testOTHER

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

Home-based test and skin test
Skin testOTHER

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

Home-based test and skin test

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent after participants' information
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Skin Tests

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med

Study Record Dates

First Submitted

March 17, 2017

First Posted

March 24, 2017

Study Start

March 30, 2017

Primary Completion

February 13, 2018

Study Completion

March 19, 2018

Last Updated

March 20, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)