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

NCT02959073 | Terminated

• 1 other identifier: ZU-HypoScore-002
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Symptom recording

Outcome Measures

Primary Outcomes (4)

• Duration of provocation test under 2 different conditions

  up to 9 weeks

• Number of score Points resulting from symptom record

  up to 9 weeks

• fel d 1 concentration in cat dander

  by collecting cat's fur

  up to 9 weeks

• fel d 1 concentration in the air

  by means of electrostatic dust collectors papers

  up to 9 weeks

Interventions

Symptom Recording OTHER

Subjects muss record their allergic symptoms after contact with their cats

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy male or female participants with age between 18 and 65 years who suffer from confirmed cat allergy. The participants have to own a cat in the house/flat where they live.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Ottawa Allery Research Corporation: collaborator

Study Sites (1)

Ottawa Allergy Research Corporation (OARC)

Ottawa, Ontario, K1G 6C6, Canada

Location

Study Officials

• Gabriela Senti Senti, Prof. Dr.

  Hypo Pet AG, c/o University of Zurich

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 8, 2016
• Study Start: September 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: May 3, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)