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

NCT02399579 | Completed

• 1 other identifier: ZU-HypoScore-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cat Allergy

Keywords

cat allergy; symptom score

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

Study Arms (1)

HypoScore

EXPERIMENTAL

Provocation test. Recording symptoms of cat allergic participants with the cat owner's cat: Before and after petting the cat.

Other: Provocation test

Interventions

Provocation test OTHER

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.

HypoScore

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Clinical Trial Center of the University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Study Officials

• Thomas M. Kündig, PD Dr. med.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 26, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 2, 2015

Record last verified: 2015-07

Locations

CH (1)