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临床试验/NCT04709614
NCT04709614已完成不适用

Influence of Immunological and Psychological Factors on Perceived Severity of Seasonal Allergic Rhinitis Caused by Grass Pollen

The University Clinic of Pulmonary and Allergic Diseases Golnik0 个研究点目标入组 39 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
39
主要终点
Symptom score

研究概览

简要总结

Objective biomarker of allergic rhinitis severity is necessary for monitoring disease severity and response to treatment in clinical setting and for research. We believe that psychological factors are the missing link between patient-perceived severity of allergic rhinitis and objective biomarkers. In our pilot study, several psychological factors were studied in relation to patient reported outcomes for severity of allergic rhinitis.

详细描述

Monitoring allergic rhinitis (AR) severity with objective biomarkers is important for the clinical management of patients as well as for research purposes. The most commonly used tool for the assessment of AR severity is the Total Nasal Symptom Score (TNSS). Objective biomarkers like skin prick test size or specific IgE levels don't correlate with TNSS.

We studied skin prick test size and specific IgE and several patient reported outcomes including symptom score, medication scores, combined score and Juniper mini rhinitis quality of life questionnaire (RQLQ). Psychometric evaluation was performed using 5 different psychological questionnaires that measure 13 different psychological factors.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • positive grass pollen skin prick test (SPT) with a wheal diameter >3mm and a history of allergic rhinitis during the grass pollen seasons

排除标准

  • positive skin prick test for perennial allergens and allergens with potentially overlapping seasons including cypress, ash/olive, plane, and nettle families

结局指标

主要结局

Symptom score

时间窗: 2 months

Symptom severity was graded on a visual analogue scale (VAS), ranging from 0 (no symptoms) to 10 (very severe symptoms)

次要结局

未报告次要终点

研究者

发起方
The University Clinic of Pulmonary and Allergic Diseases Golnik
申办方类型
Other
责任方
Sponsor

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