Observational Study With PASCALLERG ® in Patients With Hay Fever
关键词
抽象
描述
There are documented male and female patients over the age of one year who suffer from hay fever. The traetment time is about a period of 4 weeks with PASCALLERG® tablets.
日期
| 最后验证: | 03/31/2017 |
| 首次提交: | 07/31/2012 |
| 提交的预估入学人数: | 08/05/2012 |
| 首次发布: | 08/08/2012 |
| 上次提交的更新: | 04/03/2017 |
| 最近更新发布: | 06/18/2017 |
| 首次提交结果的日期: | 04/20/2016 |
| 首次提交质量检查结果的日期: | 04/03/2017 |
| 首次发布结果的日期: | 06/18/2017 |
| 实际学习开始日期: | 01/31/2012 |
| 预计主要完成日期: | 06/30/2013 |
| 预计完成日期: | 06/30/2013 |
状况或疾病
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| PASCALLERG® tablets in patients with hay fever Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study. |
资格标准
| 有资格学习的年龄 | 1 Year 至 1 Year |
| 有资格学习的性别 | All |
| 取样方式 | Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - hay fever Exclusion Criteria: - Lactose intolerance and / or - Chromium hypersensitivity |
结果
主要结果指标
1. Efficacy of Pascallerg [appr. 4 weeks after baseline (after appr. 4 weeks of treatment)]
2. Tolerability [app. 4 weeks after baseline (treatment app. for 4 weeks)]
次要成果指标
1. Numerical Rating Scale Well Beeing (Pre- Post) [Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)]
2. Change of Symptom Dry Eyes (Pre- Post) [Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)]
3. Change of Symptom Itching Eyes (Pre- Post) [Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)]
4. Change of Symptom Burning Eyes (Pre-post) [Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)]
5. Change of Symptom Bronchial Complaints (Pre-post) [Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)]
6. Change of Symptom Sneezing (Pre-post) [Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)]
7. Change of Symptom Rhinitis (Pre-post) [Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)]
8. Change of Symtom Fatigue / Tiredness [Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)]
9. Change of Symptom Headache (Pre-post) [Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)]
10. Change of Symptom Tearing Eyes (Pre-post) [Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)]
