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Evaluating Symptom Control in in Allergic Rhinitis at Three Years After Starting Immunotherapy

2013年10月24日更新者：Universitaire Ziekenhuizen KU Leuven

Allergic rhinitis (AR) is defined as inflammation of the nasal mucosa after exposition to an allergen in sensitized patients. AR causes not only nasal symptoms such as sneezing, itchy nose, rhinorrhea and nasal obstruction, but also has a significant impact on quality of life. Symptom control and overall satisfaction in patients undergoing subcutaneous immunotherapy (SCIT) or sublingual immunotherapy (SLIT) on the long term has not yet been investigated so far.

研究概览

地位

完全的

条件

过敏性鼻炎

研究类型

观察性的

注册 (实际的)

434

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

比利时
- Vlaams-Brabant
  - Leuven、Vlaams-Brabant、比利时、3000
    - ORL
- Vlaams-brabant
  - Leuven、Vlaams-brabant、比利时、3000
    - UZ Leuven

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

19年至 59年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

patients who started immunotherapy

描述

Inclusion Criteria:

Patients with at least 2 AR symptoms and a positive skin prick test for the 20 most prevalent inhalant allergens (house dust mites, grass pollen, tree pollen, animal dander, Alternaria, Penicillium and Cladosporium) in Belgium.
Moderate/severe and/or persistent AR according to ARIA guidelines
Age > 18 and < 60 years.
Written informed consent
Dutch, French or English speaking patients

Exclusion Criteria:

Exclusion criteria

Age < 18 and > 60 years
Patients with mild AR
Patients not being able to give an informed consent
Patients being enrolled in other clinical trials
No knowledge of Dutch, French or English

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
control group a control group of AR patients who visited the ear nose and throat (ENT) department of the University Hospitals Leuven in the same time period
patients having SCIT patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Current Medication Use Three Years After Diagnosis of AR 大体时间：3 years after starting SCIT	Percentage patients in both groups that still use medication for their allergic rhinitis symptoms, 3 years after starting their therapy (non IT-group vs IT-group)	3 years after starting SCIT
Degree of Symptom Control 3 Years After IT or 3 Years After Medical Treatment With VAS of Total Nasal Symptom < 5/10 Defined as a Controlled Situation. 大体时间：3 years after diagnosis	Visual analogue scale (VAS) scores for TNS experienced during the last 4 weeks. Visual analog scales (VAS) have been used to rate the presence of symptoms or impairment of the daily activities. Patients had to answer each question by indicating a position with a vertical line between two endpoints, 0 cm for not bothersome versus 10 cm for extremely bothersome. In this way each question is scored between 0 and 10 points.	3 years after diagnosis

次要结果测量

结果测量	措施说明	大体时间
Percentage of Patients Having Controlled Allergic Rhinosinusitis (AR) Symptoms 3 Years After Starting Treatment 大体时间：3 years after starting SCIT	Based on the proposed cut-off value of VAS < 5/10 for total nasal symptoms (TNS), rhinitis was considered as being controlled in 69 IT patients (84%) versus 223 (63%) non-IT patients	3 years after starting SCIT
Percentage of Patients That Met ARIA Criteria for Mild AR Symtoms at a Mean Interval of 3 Years After Diagnosis 大体时间：3 years after diagnosis	ARIA classification of AR is made by duration and severity of AR symptoms. Here are calculated the number of patients having mild acute rhinitis. Clinical practice guidelines such as the Allergic Rhinitis and its Impact on Asthma (ARIA) document focus on the quality of life as a principal consideration in assessment and treatment of AR	3 years after diagnosis

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Universitaire Ziekenhuizen KU Leuven

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年12月1日

初级完成 (实际的)

2013年6月1日

研究完成 (实际的)

2013年6月1日

研究注册日期

首次提交

2013年1月23日

首先提交符合 QC 标准的

2013年1月23日

首次发布 (估计)

2013年1月28日

研究记录更新

最后更新发布 (估计)

2013年12月17日

上次提交的符合 QC 标准的更新

2013年10月24日

最后验证

2013年10月1日