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临床试验/NCT03636919
NCT03636919已完成不适用

CRD and mHealth for Pollen Allergy in Southern Europe. A Multicenter Observational Study

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2018年1月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
900
试验地点
1
主要终点
adapted treatment

研究概览

简要总结

Pollen allergic rhinitis is a very common condition whose symptomatic treatment is not always sufficient or satisfactory. The indication for allergic immunotherapy (IT) therefore often arises. The indication is based on the interrogation of the patient (chronology and severity of symptoms) and skin tests. But the interrogation, necessarily retrospective, brings often vague information and skin tests can be positive for allergens that have no clinical role (cross allergies).

The objective of the project is to help the clinician in the indication of the IT, on the one hand by setting up a prospective and computerized collection of symptoms by a computer logbook accessible by the mobile phone of the patient. on the other hand by performing on the patient's serum a molecular diagnosis allow the identification of the major allergens to which the patient is sensitized.

The same study will be conducted in 7 centers in southern European countries in patients aged 10 to 60 years with pollinosis. The examinations added by the research will take place during two routine visits: during a first visit, these patients will answer a standardized questionnaire, have a battery of allergological skin tests and a blood sample for molecular diagnosis. An application will then be loaded on their mobile phone and they will record their symptoms and medication during the pollen season. During a second visit, at the end of the pollen season, the allergist, in view of the data collected in the electronic notebook and the results of the molecular diagnosis will be able to prescribe a possible IT.

详细描述

Pollen allergic rhinitis is a very common condition whose symptomatic treatment is not always sufficient or satisfactory. The indication for allergic immunotherapy (IT) therefore often arises. The indication is based on the interrogation of the patient (chronology and severity of symptoms) and skin tests. But the interrogation, necessarily retrospective, brings often vague information and skin tests can be positive for allergens that have no clinical role (cross allergies).

The objective of the project is to help the clinician in the indication of the IT, on the one hand by setting up a prospective and computerized collection of symptoms by a computer logbook accessible by the mobile phone of the patient. on the other hand by performing on the patient's serum a molecular diagnosis allow the identification of the major allergens to which the patient is sensitized.

The same study will be conducted in 7 centers in southern European countries (where the diagnosis of pollen allergies is the most complex) in patients aged 10 to 60 years with pollinosis. The examinations added by the research will take place during two routine visits: during a first visit, these patients will answer a standardized questionnaire, have a battery of allergological skin tests and a blood sample for molecular diagnosis. An application will then be loaded on their mobile phone and they will record their symptoms and medication during the pollen season. During a second visit, at the end of the pollen season, the allergist, in view of the data collected in the electronic notebook and the results of the molecular diagnosis will be able to prescribe a possible IT.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • over the age of 18, good French, possession of a SmartPhone, Android or i-Phone, signature of the consent form.

排除标准

  • Immunotherapy already performed, other severe chronic disease (eg dysimmunitary disease, immunodeficiency, chronic sinusitis and nasal polyposis), residence more than 30 km from the pollen sensor

结局指标

主要结局

adapted treatment

时间窗: 8 months

The number of patients who had recourse to the theoretical treatment of AIT

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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