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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02399579
Enrollment
10
Registered
2015-03-26
Start date
2015-03-31
Completion date
2015-06-30
Last updated
2015-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cat Allergy

Keywords

cat allergy, symptom score

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.

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.

Interventions

OTHERProvocation 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.

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time until the participant becomes symptomaticapprox. 15 minutes (during Provocation Test)How long can the owner pet his/her cat until he becomes symptomatic?

Secondary

MeasureTime 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 Valuesapprox. 5 minutes (before provocation)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026