Cat AllergyHypoScore-2NCT02959073
Evaluation of a New Self-assessed, Home-based Symptom Score in Cat Allergic Patients
An observational study of Cat Allergy, run by University of Zurich at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cat Allergy
- What is being tested?
- Symptom Recording
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Ottawa Allergy Research Corporation (OARC)
Ottawa, Ontario, K1G 6C6
About this study
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
- Being tested
- Symptom Recording
- Keywords
- Symptom recording
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom RecordingOther
Subjects muss record their allergic symptoms after contact with their cats
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of provocation test under 2 different conditions
Measured: up to 9 weeks
Number of score Points resulting from symptom record
Measured: up to 9 weeks
fel d 1 concentration in cat dander
by collecting cat's fur
Measured: up to 9 weeks
fel d 1 concentration in the air
by means of electrostatic dust collectors papers
Measured: up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: Company's strategic reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cat AllergyStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Allery Research Corporation
- Responsible party
- Sponsor
- Investigators
- Gabriela Senti Senti, Prof. Dr., Study director, Hypo Pet AG, c/o University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959073
- Sponsor's protocol ID
- ZU-HypoScore-002
- Acronym
- HypoScore-2
- Status last verified
- May 2017
- First submitted
- 3 Nov 2016
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Self-assessed, Home-based Symptom Score in Cat Allergic Patients
- ClinicalTrials.gov ID
- NCT02959073
- Acronym / sponsor ID
- HypoScore-2 / ZU-HypoScore-002
- Conditions
- Cat Allergy
- Keywords
- Symptom recording
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Company's strategic reasons
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Ottawa Allery Research Corporation
- Study start
- Sep 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symptom RecordingSubjects muss record their allergic symptoms after contact with their cats | Other | – |
Primary outcome
Duration of provocation test under 2 different conditions
Time frame: up to 9 weeks
Number of score Points resulting from symptom record
Time frame: up to 9 weeks
fel d 1 concentration in cat dander
Time frame: up to 9 weeks
by collecting cat's fur
fel d 1 concentration in the air
Time frame: up to 9 weeks
by means of electrostatic dust collectors papers
Results and safety
The study was stopped early (reason given: Company's strategic reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriela Senti Senti, Prof. Dr. study director
Hypo Pet AG, c/o University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cat Allergy, run by University of Zurich at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Company's strategic reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of provocation test under 2 different conditions (time frame: up to 9 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.