Evaluation of a New Self-assessed, Home-based Symptom Sco... | NCT02959073

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

NCT02959073

Sponsor

University of Zurich

Status

Terminated

Last Update Posted

May 3, 2017Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Cat Allergy

Interventions

Symptom Recording

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Company's strategic reasons

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Feb 2017Actual

Completion Date

Feb 2017Actual

First Submitted Date

Nov 3, 2016

First Submission Date that Met QC Criteria

Nov 7, 2016

First Posted Date

Nov 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2017

Last Update Posted Date

May 3, 2017Actual

Name	Class
Ottawa Allery Research Corporation	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Name	Type	Description	Arm Group Labels	Other Names
Symptom Recording	Other	Subjects muss record their allergic symptoms after contact with their cats

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample