Cat Allergy Clinical Trial
— HypoScore-2Official title:
Evaluation of a New Self-assessed, Home-based Symptom Score in Cat Allergic Patients
Verified date | May 2017 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 10 |
Est. completion date | February 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Ottawa Allergy Research Corporation (OARC) | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Zurich | Ottawa Allery Research Corporation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of provocation test under 2 different conditions | up to 9 weeks | ||
Primary | Number of score Points resulting from symptom record | up to 9 weeks | ||
Primary | fel d 1 concentration in cat dander | by collecting cat's fur | up to 9 weeks | |
Primary | fel d 1 concentration in the air | by means of electrostatic dust collectors papers | up to 9 weeks |
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