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

Cat Allergy Clinical Trial

— HypoScore-2  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02959073
• Other study ID #: ZU-HypoScore-002
• Status: Terminated
• Phase: N/A
• First received: November 3, 2016
• Last updated: May 2, 2017
• Start date: September 2016
• Est. completion date: February 2017

Study information

• Verified date: May 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cat Allergy

Intervention

Other:
• Symptom Recording
Subjects muss record their allergic symptoms after contact with their cats

Locations

Country	Name	City	State
Canada	Ottawa Allergy Research Corporation (OARC)	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Ottawa Allery Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

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