NCT02065440Unknown不适用
The Effect of Ebastine/Pseudoephedrine on Subacute Cough :a Randomized Placebo-controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Change of VAS score
研究概览
简要总结
To determine whether ebastine/pseudoephedrine is effective on subacute cough.
详细描述
- Visit 0 week
- Patients with subacute cough,area randomized to either ebastine/pseudoephedrine or placebo for 1 week.
- The cough severity and quality of life were measure with VAS score and cough-specific quality-of-life questionnaire(CQLQ)
- Visit 1 week check VAS score and CQLQ
- Visit 4 weeks check VAS score and CQLQ
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with subacute cough(3-8 weeks)
- •age: 20-70 years
排除标准
- •Chest X-ray abnormality(+) as a probable cause of cough
- •other explainable confirmed diagnosis(+) such as acute infectious disease
- •Severe cough or cough complication which needs other anti-tussive agents.
- •with more than three hypertensive agents
- •change of hypertension medication 3 months ago
- •immunocompromized host
- •relative or absolute contraindication for ebastine/pseudoephedrine
- •hypersensitivity to ebastine/pseudoephedrine
- •moderate to severe hypertensive disease
- •coronary heart disease
- •hyperthyroidism
- •moderate to severe liver disease
- •benign prostate hyperplasia
- •psychological problem
- •Parkinson's disease
- •on linezolid or supposed to use it.
研究组 & 干预措施
Ebastine/Pseudoephedrine
Active Comparator
administration of ebastine/pseudoephedrine 1cap/day for 1 week.
干预措施: Rhinoebastel (Drug)
placebo
Placebo Comparator
administration of placebo pill 1 cap/day for 1week
干预措施: Placebo (Drug)
结局指标
主要结局
Change of VAS score
时间窗: 1 week later after administration of ebastine/pseudoephedrine or placebo
次要结局
- Change of VAS score(4 weeks later after administration of ebastine/pseudoephedrine or placebo)
- The proportion of patients with more than 50 percent decrease in VAS score(1 week)
- Change of CQLQ score(4 weeks later after administration of ebastine/pseudoephedrine or placebo)
- The adverse events(4 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
The Effect of Pseudoephedrine on Rhinitis and SleepSleepRhinitisNCT00704496Milton S. Hershey Medical Center34
已完成
不适用
Effectiveness of Prophylactic Bolus Ephedrine Versus Norepinephrine for Management of Post Spinal HypotensionComparing Ephedrine With Norepinephrine for Mangement Postspinal HypotensionNCT05522088Wachemo University84
已完成
不适用
Exploring the activity of pseudoephedrine in treating retrograde ejaculation following retroperitoneal lymph node dissection (RPLND) in survivors of testicular cancer - Part ATesticular cancerRetroperitoneal lymph node dissectionCancer - TesticularSurgery - Other surgeryACTRN12622000537752Peter MacCallum Cancer Centre52
已完成
4 期
Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma ExacerbationAsthmaNCT01705964University of Louisville49
已完成
1 期
Epinastine and Pseudoephedrine Fixed Combination Compared to Separate Administration in Healthy VolunteersHealthyNCT02182531Boehringer Ingelheim25