Evaluation of a New Self-assessed, Home-based Symptom Score in Cat Allergic Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of score Points resulting from symptom record
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •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.
排除标准
- •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
结局指标
主要结局
Number of score Points resulting from symptom record
时间窗: up to 9 weeks
fel d 1 concentration in cat dander
时间窗: up to 9 weeks
by collecting cat's fur
Duration of provocation test under 2 different conditions
时间窗: up to 9 weeks
fel d 1 concentration in the air
时间窗: up to 9 weeks
by means of electrostatic dust collectors papers
次要结局
未报告次要终点