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

Cat Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02399579
• Other study ID #: ZU-HypoScore-001
• Status: Completed
• Phase: N/A
• First received: March 17, 2015
• Last updated: July 1, 2015
• Start date: March 2015
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cat Allergy

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Clinical Trial Center of the University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Number of score points resulting from symptom score recording before and after the provocation test.		approx. 15 minutes (before and after provocation)	No
Secondary	Visual Analogue Scale Values		approx. 5 minutes (before provocation)	No