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Completed

NCT Number: NCT02399579

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center of the University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Time until the participant becomes symptomatic

    Time frame: approx. 15 minutes (during Provocation Test)

    How long can the owner pet his/her cat until he becomes symptomatic?

Secondary outcomes

  1. Number of score points resulting from symptom score recording before and after the provocation test.

    Time frame: approx. 15 minutes (before and after provocation)

  2. Visual Analogue Scale Values

    Time frame: approx. 5 minutes (before provocation)

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 26, 2015
Registry last updated
Jul 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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