Methodological Study to Compare the Effect of Different Methods of Measuring Cat Allergy Symptoms in Patients That Have Immunized Their Cats With FEL-CMV.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Organ specific symptom sum score of HypoScore measured after petting the cat at baseline versus week 24
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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)
研究组 & 干预措施
Home-based test and skin test
干预措施: Home-based test (Other)
Home-based test and skin test
干预措施: Skin test (Other)
结局指标
主要结局
Organ specific symptom sum score of HypoScore measured after petting the cat at baseline versus week 24
时间窗: 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)
时间窗: Measured over 25 weeks
General weekly symptom score is measured with a weekly questionnaire. This questionnaire will be filled in on a weekly Basis.
次要结局
未报告次要终点
研究者
Thomas Kuendig
Prof. Dr. med
University of Zurich