NCT01953471已完成不适用
Determination of Minimal Clinically Important Difference of Allergic Rhinitis Symptoms Due to Grass Pollen by the Assessment of the Relationship Between the Symptom Scores and Global Rating of Change Questionnaires on the Quality of Life and Well-being.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 959
- 试验地点
- 1
- 主要终点
- Rhinitis Total Symptoms Score (RTSS), (intensity of each symptom measured on a 4-point scale) compared to a 15-point global rating of change questionnaire.
研究概览
简要总结
Prospective multi-center study carried out in France involving patients with allergic rhinitis. Study in usual care where no specific diagnostic or therapeutic procedure is required. The patients will be asked to fill in Questionnaires on a daily and weekly basis.
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
- 6 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged between 6 and 65 years.
- •Patients who have been informed of the nature and aims of the study and have given their written consent to participate in this study in accordance with local laws and requirements.
- •Patient with an Grass pollen-related allergic rhinitis (immunologically and / or symptomatically treated or non treated).
- •Patients presented for symptomatic management of allergic rhinitis.
- •Patients having Symptoms score ≥ 6.
排除标准
- •Patients involved in any other clinical/observational study.
- •patients unable to fill in the study questionnaires.
- •Patient suffering from any diagnosed disease that may interfere with the evaluation of allergic rhinoconjunctivitis' related quality of life, fatigue and daily activities.
- •Patients treated with any drug that may influence the patient's fatigue and/or interfere with psychomotor performance.
- •Patients suffering from persistent asthma, or asthma exacerbation during grass pollen season.
结局指标
主要结局
Rhinitis Total Symptoms Score (RTSS), (intensity of each symptom measured on a 4-point scale) compared to a 15-point global rating of change questionnaire.
时间窗: 6 months per patient
次要结局
未报告次要终点
研究者
研究点 (1)
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