Evaluation of a New Self-assessed, Home-based Symptom Score in Cat Allergic Patients

Terminated

• Conditions: Cat Allergy

• Registration Number: NCT02959073
• Lead Sponsor: University of Zurich

Brief Summary

In the last decades the prevalence of allergies has reached epidemic proportions. 10 to 15% of the population suffers from cat allergy. Investigators perform this study in order to further investigate symptom records and their evaluation in cat allergic patients.

Investigators primarily aim to better standardize the symptom recording of cat allergic persons under real-life conditions and to evaluate the effect of hypoallergenic cats on symptom strength.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-11-07
• Study First Posted: 2016-11-08
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 equal or greater 3 mm) when tested with already standardized cat allergen extract.
• Positive screening prick test (wheal diameter equal or greater 3mm) to Histamine dihydrochloride 10 mg/ml.
• Positive Scratch Test when tested with cat dander sample of participant's cat.
• Baseline symptoms with a severity of "1" in at least 2 different symptoms.
• Owner of a cat that lives in the same household.
• Cat will not have been washed in the 4 weeks before starting the test phase.

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 according to section 8.3 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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of score Points resulting from symptom record	up to 9 weeks
fel d 1 concentration in cat dander	up to 9 weeks	by collecting cat's fur
Duration of provocation test under 2 different conditions	up to 9 weeks
fel d 1 concentration in the air	up to 9 weeks	by means of electrostatic dust collectors papers

Trial Locations

Locations (1)

Ottawa Allergy Research Corporation (OARC); 🇨🇦 Ottawa, Ontario, Canada