Cat AllergyNCT02399579
Evaluation of a New Self-Assessed, Home-Based Symptom Score Test in Cat Allergic Patients
A study testing Provocation test in people with Cat Allergy, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to better standardize the symptom recording of cat allergic persons under real-life conditions. A new self-assessed, home-based symptom score will be tested. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cat Allergy
- What is being tested?
- Provocation test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2015to Jun 2015
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
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 ≥ 3 mm) when tested with already standardized cat allergen extract.
- Positive screening prick test (wheal diameter ≥ 3mm) to Histamine dihydrochloride 10mg/ml.
- Positive Scratch Test when tested with cat dander sample of participant's cat.
- Baseline symptoms with a severity of at least "1" in minimal 2 various symptoms.
- Owner of a cat that lives in the same household.
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
Show all 11Show fewer
- 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 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.
Switzerland1 site
Clinical Trial Center of the University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
The purpose of this study is to better standardize the symptom recording of cat allergic persons under real-life conditions. A new self-assessed, home-based symptom score will be tested.
Read the detailed description
In order to bring research on cat dander allergy a step further we aim to investigate cat dander allergy symptoms and record them in a natural environment, respectively, i.e. at the participant's home. For this purpose we aim to test a new self-assessed, homebased symptom score (called HypoScore). The participants will perform 8 provocation tests. Every provocation test consists of petting the cat until the participants become symptomatic. The participants have to pet the cat everytime in the same manner. Directly before and after the provocation test the symptoms will be recorded in the eCRF by using an iPad mini.
- Conditions
- Cat Allergy
- Being tested
- Provocation test
- Keywords
- cat allergy, symptom score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provocation testOther
The participants will perform 8 provocation tests. Every provocation test consists of petting the cat until the participants become symptomatic. The symptoms of cat allergic participants with the cat owner's cat will be recorded before and after petting the cat.
| Study group | Role | What they receive |
|---|---|---|
| HypoScore | Experimental | Provocation test. Recording symptoms of cat allergic participants with the cat owner's cat: Before and after petting the cat. Receives: Other: Provocation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until the participant becomes symptomatic
How long can the owner pet his/her cat until he becomes symptomatic?
Measured: approx. 15 minutes (during Provocation Test)
Secondary outcomes (2)
Number of score points resulting from symptom score recording before and after the provocation test.
Measured: approx. 15 minutes (before and after provocation)
Visual Analogue Scale Values
Measured: approx. 5 minutes (before provocation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionJun 2015
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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas M. Kündig, PD Dr. med., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399579
- Sponsor's protocol ID
- ZU-HypoScore-001
- Status last verified
- Jul 2015
- First submitted
- 17 Mar 2015
- Last updated
- 2 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. 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 Test in Cat Allergic Patients
- ClinicalTrials.gov ID
- NCT02399579
- Acronym / sponsor ID
- ZU-HypoScore-001
- Conditions
- Cat Allergy
- Keywords
- cat allergy, symptom score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Mar 2015 (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.
The purpose of this study is to better standardize the symptom recording of cat allergic persons under real-life conditions. A new self-assessed, home-based symptom score will be tested.
Detailed description
In order to bring research on cat dander allergy a step further we aim to investigate cat dander allergy symptoms and record them in a natural environment, respectively, i.e. at the participant's home. For this purpose we aim to test a new self-assessed, homebased symptom score (called HypoScore). The participants will perform 8 provocation tests. Every provocation test consists of petting the cat until the participants become symptomatic. The participants have to pet the cat everytime in the same manner. Directly before and after the provocation test the symptoms will be recorded in the eCRF by using an iPad mini.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HypoScore | Experimental | Other: Provocation testProvocation test. Recording symptoms of cat allergic participants with the cat owner's cat: Before and after petting the cat. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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 ≥ 3 mm) when tested with already standardized cat allergen extract.
- Positive screening prick test (wheal diameter ≥ 3mm) to Histamine dihydrochloride 10mg/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 |
|---|---|---|
| Provocation testThe participants will perform 8 provocation tests. Every provocation test consists of petting the cat until the participants become symptomatic. The symptoms of cat allergic participants with the cat owner's cat will be recorded before and after petting the cat. | Other | HypoScore |
Primary outcome
Time until the participant becomes symptomatic
Time frame: approx. 15 minutes (during Provocation Test)
How long can the owner pet his/her cat until he becomes symptomatic?
2 secondary outcomes
Number of score points resulting from symptom score recording before and after the provocation test.
Time frame: approx. 15 minutes (before and after provocation)
Visual Analogue Scale Values
Time frame: approx. 5 minutes (before provocation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
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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.
Thomas M. Kündig, PD Dr. med. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provocation test in people with Cat Allergy, run by University of Zurich at 1 site in Switzerland.
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 8 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: finished, as of the sponsor's last update on 2 Jul 2015. 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 Switzerland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time until the participant becomes symptomatic (time frame: approx. 15 minutes (during Provocation Test)). 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 2 Jul 2015.