NCT01964768已完成3 期
Determination of Sensitivity and Specificity of Three Solutions of Allergen Extract (5 Grasses, Birch Pollens and Dermatophagoides Pteronyssinus Mites) for Diagnosis by Skin Prick Testing
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 324
- 主要终点
- Skin wheal measure for each tested solution. For each allergen tested, 2 variables, positive SPT and negative SPT were defined. A SPT reaction was considered positive when the mean wheal diameter was >3 mm. A SPT reaction ≤3 mm was considered negative.
研究概览
简要总结
A Phase III study to determine the sensitivity and specificity of three solutions of different allergen extracts for diagnosis by skin prick-test:
- 5 Grasses pollen,
- Birch pollen,
- Dermatophagoides pteronyssinus mite
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 5 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent to participate in the study
- •Male or female subjects aged 5-60 years inclusive
- •Female of childbearing potential must be on a reliable method of contraception and have a negative urine pregnancy test
- •Presence of a clinical history of allergy: seasonal or perennial rhinitis, conjunctivitis and/or asthma during grass or birch pollen seasons (at least two pollen seasons) and/or due to mite exposure (at least two years)
- •Subjects affiliated to a social security system
排除标准
- •Pregnant or breastfeeding women
- •Dermographism
- •Absence of cutaneous reactivity
- •Presence of cutaneous lesions on the forearms either preventing the performance of the test or potentially interfering with the interpretation of the test
- •Subjects presenting unstable asthma or poor general health condition
- •Subjects with past or current specific immunotherapy treatment for any of the 3 tested allergens (Grass, Birch pollens, D. pteronyssinus and/or D. farinae mites) in the previous 5 years
- •Any oral antihistaminic treatment in the previous 3 days or 10 days in case of loratadine or desloratadine
- •Subjects on anti-IgE treatment
- •Subjects treated with beta-blockers and/or anti-depressives.
- •Subjects currently participating in another clinical trial or still in exclusion period for a previous clinical trial
- •Investigators, co-investigators, as well as their children or spouses and all the study collaborators
- •Subjects under protection of the courts, legal guardianship or legal trusteeship
结局指标
主要结局
Skin wheal measure for each tested solution. For each allergen tested, 2 variables, positive SPT and negative SPT were defined. A SPT reaction was considered positive when the mean wheal diameter was >3 mm. A SPT reaction ≤3 mm was considered negative.
时间窗: For each subject, the study consisted in one visit of about 60 minutes including skin prick-test and collection of blood sample for IgE determination.
次要结局
- One of the secondary measurement was the wheal diameter for each allergen.(SPT measurements were performed after the study visit, an expected average of 1 week.)
研究者
相似试验
尚未招募
不适用
Comparison in Sensitivity and Specificity of 3 Sleep Questionnaires to Screen Obstructive Sleep Apnea in Patients with Morbid ObesityObstructive sleep apnea Morbid obesityObstructive sleep apneaMorbid obesityEpworth sleepiness scaleSTOP-Bang questionnaireBerlin questionnaireTCTR20210331004Thammasat University Hospital205
招募中
3 期
A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of AgeChickenpoxNCT06740630GlaxoSmithKline1,840
招募中
不适用
Study to investigate possible applications for MRI and ultrasound in the diagnosis of atherosclerosis of the carotid artery.NL-OMON26704Academic Medical Center50
已完成
不适用
A study to evaluate a rapid influenza test in subjects presenting to doctors' clinics with influenza like symptomsInfection - Other infectious diseasesInfluenzaACTRN12609000352202Inverness Medical (IMI)750
尚未招募
不适用
Study to investigate the sensitivity and specificity of 3.0 Tesla MRI, MRS and ultrasound imaging for carotid artery plaque dimension and composition assessment.10003216atherosclerosisNL-OMON36476Academisch Medisch Centrum150