Treatment With Rhinospray Plus of Patients With Acute Rhinitis in the Everyday Curative Routine in Hungary
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- The Mean of the 2 Single Quality of Life Improvement Scores at the Closing/Final Visit for Daytime Activities and Quality of Sleep
研究概览
简要总结
Multi-centre, open-label, prospective, uncontrolled, single-arm, non-interventional study (NIS) with objective to collect and evaluate data concerning treatment with Rhinospray Plus in everyday curative routine treatment of acute rhinitis
详细描述
Study Design:
open, observational, single-arm, uncontrolled
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The Mean of the 2 Single Quality of Life Improvement Scores at the Closing/Final Visit for Daytime Activities and Quality of Sleep
时间窗: up to day 11
The mean score of the following two "quality of life improvement" questions at the final/closing visit was calculated: "How did Rhinospray plus improve the quality of your daytime activities?" and "How did Rhinospray Plus improve the quality of your sleep?". The scores range from 1=strongly to 4=no improvement. Thus also the range of the mean score is from 1 to 4.
The Change From Baseline in the Mean of the 3 Single Symptom Scores (Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit.
时间窗: Baseline and up to day 11
Patients scored the symptoms (blocked nose, sneezing and running nose) on a 4-point rating scale with 0=absent, 1=mild, 2=moderate, 3=severe. The range of the mean score thus could be between 0 and 3. The change in the mean of the 3 single scores was calculated by the score at the final visit minus the score at baseline. Therefore, a negative change represents an improvement of the mean score.
次要结局
- Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit.(up to day 11)
- Subjective Assessment of the Physicians of Overall Treatment Efficacy at the Closing/Final Visit.(up to day 11)
- Subjective Assessment of the Physicians of Overall Treatment Tolerability at the Closing/Final Visit.(up to day 11)
- The Single Score of Quality of Life Improvement at the Closing/Final Visit for Daytime Activities(up to 11 days)
- Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit.(up to day 11)
- The Change From Baseline in the Single Symptoms Scores ( Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit(Baseline and up to day 11)
- The Single Score of Quality of Life Improvement at the Closing/Final Visit for Quality of Sleep(Up to day 11)