Evaluation of a New Self-assessed, Home-based Symptom Score in Cat Allergic Patients (HypoScore-2)

In the last decades the prevalence of allergies has reached epidemic proportions. 10 to 15% of the population suffers from cat allergy. Investigators perform this study in order to further investigate symptom records and their evaluation in cat allergic patients.

Investigators primarily aim to better standardize the symptom recording of cat allergic persons under real-life conditions and to evaluate the effect of hypoallergenic cats on symptom strength.

Study Overview

• Status: Terminated
• Conditions: Cat Allergy
• Intervention / Treatment: Other: Symptom Recording

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1G 6C6
      • Ottawa Allergy Research Corporation (OARC)

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

• Sampling Method: Probability Sample

Study Population

Healthy male or female participants with age between 18 and 65 years who suffer from confirmed cat allergy. The participants have to own a cat in the house/flat where they live.

Description

Inclusion Criteria:

• Participant understands the nature, meaning and scope of the study.
• Signed Informed Consent after being informed.
• Male and Female patients 18 years to 65 years of age.
• Positive screening prick test (mean wheal diameter equal or greater 3 mm) when tested with already standardized cat allergen extract.
• Positive screening prick test (wheal diameter equal or greater 3mm) to Histamine dihydrochloride 10 mg/ml.
• Positive Scratch Test when tested with cat dander sample of participant's cat.
• Baseline symptoms with a severity of "1" in at least 2 different symptoms.
• Owner of a cat that lives in the same household.
• Cat will not have been washed in the 4 weeks before starting the test phase.

Exclusion Criteria:

• Impaired in understanding the nature, meaning and scope of the study or incapable of giving written informed consent
• Participation in another study with investigational drug within the 30 days preceding and during the present study
• Women who are pregnant or breast feeding
• Intention to become pregnant during the course of the study
• Positive skin reaction in the 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 according to section 8.3 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 patient should not suffer from other respiratory allergies during this study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of provocation test under 2 different conditions		up to 9 weeks
Number of score Points resulting from symptom record		up to 9 weeks
fel d 1 concentration in cat dander	by collecting cat's fur	up to 9 weeks
fel d 1 concentration in the air	by means of electrostatic dust collectors papers	up to 9 weeks

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Ottawa Allery Research Corporation
• Investigators: Study Director: Gabriela Senti Senti, Prof. Dr., Hypo Pet AG, c/o University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: November 3, 2016
• First Submitted That Met QC Criteria: November 7, 2016
• First Posted (Estimate): November 8, 2016

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Symptom recording
• Other Study ID Numbers: ZU-HypoScore-002

Plan for Individual participant data (IPD)

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