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

NCT ID: NCT02959073

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-02-28

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.

Conditions

Cat Allergy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Symptom Recording

Subjects muss record their allergic symptoms after contact with their cats

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ottawa Allery Research Corporation

UNKNOWN

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabriela Senti Senti, Prof. Dr.

Role: STUDY_DIRECTOR

Hypo Pet AG, c/o University of Zurich

Locations

Ottawa Allergy Research Corporation (OARC)

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

ZU-HypoScore-002

Identifier Type: -

Identifier Source: org_study_id