HypersensitivityNCT03089788
Methodological Study to Compare the Effect of Different Methods of Measuring Cat Allergy Symptoms in Patients That Have Immunized Their Cats With FEL-CMV.
A study testing Home-based test and Skin test in people with Hypersensitivity, run by University of Zurich at 1 site in Switzerland.
Trial summary
In this Project we will monitor the symptoms of cat allergic participants who live together with a cat which is immunized with FEL-CMV using the novel symptom recording method "HypoScore", a General weekly symptom score, and a skin prick test before and after immunization of the cat. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypersensitivity
- What is being tested?
- Home-based test and Skin test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Mar 2017to 19 Mar 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent after participants' information
- 18 to 65 years, male or female
- Participant understands the nature, meaning and scope of the study
- Positive screening prick test (wheal diameter ≥ 3mm) to Histamine dihydrochloride 10mg/ml
- Positive screening prick test (mean wheal diameter ≥ 3 mm) when tested with already standardized cat allergen extract
- Positive screening scratch test when tested with cat dander sample of participant's cat.
- Living with a cat in the same household and parallel participation in the cat study in which the cat will be immunized
- A positive clinical history with inhalant allergy presumably due to cat allergen
Who cannot join
- Immunosuppression or haematological diseases, in particular anaemias or leukaemia
- Other previous or current condition or participation in clinical trials influencing the results of the present study by discretion of the investigator
- Incapable of understanding the nature, meaning or scope of the research project or incapable of giving written informed consent
- Unwilling or incapable of following the study procedures, e.g. due to language problems, psychological disorders, dementia, known or suspected drug or alcohol abuse etc.
- Women who are pregnant or breast feeding or having the intention to become pregnant during the course of the study
- Positive skin reaction in the screening prick test to negative control
Show all 12Show fewer
- 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 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 participant should not suffer from other respiratory allergies during this study (people who suffer from asthma are not excluded)
Trial locations and contacts
1 site in 1 country.
About this study
In this Project we will monitor the symptoms of cat allergic participants who live together with a cat which is immunized with FEL-CMV using the novel symptom recording method "HypoScore", a General weekly symptom score, and a skin prick test before and after immunization of the cat. This project may enable us to determine if the scoring System and the tests are able to detect a difference in participant symptoms before and after immunization of the cats.
- Conditions
- Hypersensitivity
- Being tested
- Home-based test, Skin test
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based testOther
Home-based tests in which the participant pets his/her cat until he/she reaches a certain symptom strength.
Skin testOther
Skin Prick Tests will be performed with registered cat allergen extract.
| Study group | Role | What they receive |
|---|---|---|
| Home-based test and skin test | Other | Not described Receives: Other: Home-based test; Other: Skin test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organ specific symptom sum score of HypoScore measured after petting the cat at baseline versus week 24
Organ specific symtpom score component of HypoScore is measured with a questionnaire before and after the participants perform the tests with their cats (petting the cat until certain symptoms are reached).
Measured: Comparison of the symptom score of 3 baseline measurements and measurement in week 24
General weekly symptom score measured at baseline (with unimmunized cat) versus week 24 (with immunized cat)
General weekly symptom score is measured with a weekly questionnaire. This questionnaire will be filled in on a weekly Basis.
Measured: Measured over 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start30 Mar 2017
- Primary completion13 Feb 2018
- Study completion19 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersensitivityStudies of the same condition, open and under way.
- 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
- Primary purpose
- Other
- 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
- Principal investigator, Thomas Kuendig, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089788
- Sponsor's protocol ID
- ZU-HypoCat-002
- Status last verified
- Mar 2018
- First submitted
- 17 Mar 2017
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methodological Study to Compare the Effect of Different Methods of Measuring Cat Allergy Symptoms in Patients That Have Immunized Their Cats With FEL-CMV.
- ClinicalTrials.gov ID
- NCT03089788
- Acronym / sponsor ID
- ZU-HypoCat-002
- Conditions
- Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 13 Feb 2018 (actual)
- Study completion
- 19 Mar 2018 (actual)
- First posted
- 24 Mar 2017 (actual)
- 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 this Project we will monitor the symptoms of cat allergic participants who live together with a cat which is immunized with FEL-CMV using the novel symptom recording method "HypoScore", a General weekly symptom score, and a skin prick test before and after immunization of the cat. This project may enable us to determine if the scoring System and the tests are able to detect a difference in participant symptoms before and after immunization of the cats.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-based test and skin test | Other | Other: Home-based test, Other: Skin test |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent after participants' information
- 18 to 65 years, male or female
- Participant understands the nature, meaning and scope of the study
- Positive screening prick test (wheal diameter ≥ 3mm) to Histamine dihydrochloride 10mg/ml
- Positive screening prick test (mean wheal diameter ≥ 3 mm) when tested with already standardized cat allergen extract
Key exclusion criteria (12 listed)
- Immunosuppression or haematological diseases, in particular anaemias or leukaemia
- Other previous or current condition or participation in clinical trials influencing the results of the present study by discretion of the investigator
- Incapable of understanding the nature, meaning or scope of the research project or incapable of giving written informed consent
- Unwilling or incapable of following the study procedures, e.g. due to language problems, psychological disorders, dementia, known or suspected drug or alcohol abuse etc.
- Women who are pregnant or breast feeding or having the intention to become pregnant during the course of the study
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 |
|---|---|---|
| Home-based testHome-based tests in which the participant pets his/her cat until he/she reaches a certain symptom strength. | Other | Home-based test and skin test |
| Skin testSkin Prick Tests will be performed with registered cat allergen extract. | Other | Home-based test and skin test |
Primary outcome
Organ specific symptom sum score of HypoScore measured after petting the cat at baseline versus week 24
Time frame: Comparison of the symptom score of 3 baseline measurements and measurement in week 24
Organ specific symtpom score component of HypoScore is measured with a questionnaire before and after the participants perform the tests with their cats (petting the cat until certain symptoms are reached).
General weekly symptom score measured at baseline (with unimmunized cat) versus week 24 (with immunized cat)
Time frame: Measured over 25 weeks
General weekly symptom score is measured with a weekly questionnaire. This questionnaire will be filled in on a weekly Basis.
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 20 Mar 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based test and Skin test in people with Hypersensitivity, 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 12 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 20 Mar 2018. 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?
Organ specific symptom sum score of HypoScore measured after petting the cat at baseline versus week 24 (time frame: Comparison of the symptom score of 3 baseline measurements and measurement in week 24). The study lists 2 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 20 Mar 2018.