Effect of Symbicort on Sleep Quality in Patients With Emphysema
试验速览
- 阶段
- 3 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The primary outcome is the objective assessment of sleep quality.
研究概览
简要总结
This study will look at the effects of the drug Symbicort on sleep quality. Symbicort is an inhaled medication that contains 2 drugs. One is a medication that opens up the airways (formoterol). The other is a steroid to decrease airway inflammation (budesonide). Symbicort is not an experimental medication. It is approved by the Food and Drug Administration for use in patients with emphysema. Patients with severe emphysema commonly sleep poorly. The cause of poor sleep in these patients is unknown. Symbicort may improve sleep quality by opening the airways and reducing lung inflammation. It is not known for sure if these effects actually improve sleep and quality of life. It is hoped that this study will answer this question.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe emphysema (GOLD stages 2 and 3)
排除标准
- •Use of supplemental oxygen,
- •A recent COPD exacerbation within the past 4 weeks.
- •A previous diagnosis of obstructive sleep apnea
- •A known urinary outflow obstruction,
- •History of an allergic reaction to one of the study medications.
研究组 & 干预措施
budesonide/formoterol
budesonide/formoterol 160/4.5 mcg (Symbicort)
干预措施: Budesonide/formoterol (Drug)
Placebo
Symbicort placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The primary outcome is the objective assessment of sleep quality.
时间窗: 28 days
Sleep quality will be assessed quantitatively by polysomnogram and include measurement of sleep efficiency (total sleep time/time in bed), total sleep time, and arousal index during the night. Subjective sleep quality and assessment of daytime function will be measured using the Pittsburgh sleep quality index (PSQI) and the Epworth Sleepiness scale (ESS), respectively.
次要结局
- Secondary outcome includes assessment of nocturnal oxygenation.(28 days)
- Secondary outcome is the subjective assessment of sleep quality.(28 days)
- Secondary outcome includes assessment respiratory mechanics/function.(28 days)
- Secondary outcome includes assessment of overall quality of life.(28 days)
研究者
Samuel Krachman
Principal Investigator, Professor of Medicine
Temple University