Evaluation of a New Self-Assessed, Home-Based Symptom Score Test in Cat Allergic Patients

The purpose of this study is to better standardize the symptom recording of cat allergic persons under real-life conditions. A new self-assessed, home-based symptom score will be tested.

Study Overview

• Status: Completed
• Conditions: Cat Allergy
• Intervention / Treatment: Other: Provocation test

Detailed Description

In order to bring research on cat dander allergy a step further we aim to investigate cat dander allergy symptoms and record them in a natural environment, respectively, i.e. at the participant's home. For this purpose we aim to test a new self-assessed, homebased symptom score (called HypoScore). The participants will perform 8 provocation tests. Every provocation test consists of petting the cat until the participants become symptomatic. The participants have to pet the cat everytime in the same manner. Directly before and after the provocation test the symptoms will be recorded in the eCRF by using an iPad mini.

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

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Clinical Trial Center of the University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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 ≥ 3 mm) when tested with already standardized cat allergen extract.
• Positive screening prick test (wheal diameter ≥ 3mm) to Histamine dihydrochloride 10mg/ml.
• Positive Scratch Test when tested with cat dander sample of participant's cat.
• Baseline symptoms with a severity of at least "1" in minimal 2 various symptoms.
• Owner of a cat that lives in the same household.

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 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?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HypoScore; Provocation test. Recording symptoms of cat allergic participants with the cat owner's cat: Before and after petting the cat.	Other: Provocation test; The participants will perform 8 provocation tests. Every provocation test consists of petting the cat until the participants become symptomatic. The symptoms of cat allergic participants with the cat owner's cat will be recorded before and after petting the cat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time until the participant becomes symptomatic	How long can the owner pet his/her cat until he becomes symptomatic?	approx. 15 minutes (during Provocation Test)

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of score points resulting from symptom score recording before and after the provocation test.	approx. 15 minutes (before and after provocation)
Visual Analogue Scale Values	approx. 5 minutes (before provocation)

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Thomas M. Kündig, PD Dr. med., University of Zurich

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: March 17, 2015
• First Submitted That Met QC Criteria: March 25, 2015
• First Posted (Estimate): March 26, 2015

Study Record Updates

• Last Update Posted (Estimate): July 2, 2015
• Last Update Submitted That Met QC Criteria: July 1, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: cat allergy; symptom score
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: ZU-HypoScore-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No