Clinical trial NCT02959073: Evaluation of a New Self-assessed, Home-based Symptom Score in Cat Allergic Patients
Official title: Evaluation of a New Self-assessed, Home-based Symptom Score in Cat Allergic Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cat Allergy
Keywords: Symptom recording
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Ottawa Allery Research Corporation
First posted: 2016-11-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Duration of provocation test under 2 different conditions
timeFrame: up to 9 weeks
measure: Number of score Points resulting from symptom record
timeFrame: up to 9 weeks
measure: fel d 1 concentration in cat dander
timeFrame: up to 9 weeks
measure: fel d 1 concentration in the air
timeFrame: up to 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Allergy Research Corporation (OARC)
state: Ontario
Study officials:
affiliation: Hypo Pet AG, c/o University of Zurich
name: Gabriela Senti Senti, Prof. Dr.
role: STUDY_DIRECTOR
References: