Prospective Study of Efficacy of Sham CPAP vs. Straight CPAP on Cough Intensity in Patients With Chronic Cough
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in Leicester Cough Questionnaire Score
研究概览
简要总结
Chronic cough is an important clinical problem in primary care and sub-specialty practice. Besides the distress experienced by patients with chronic cough, significant healthcare resources are expended to understand the role of gastroesophageal reflux, asthma and post-nasal drip in understanding their contribution to cough.
Obstructive sleep apnea (OSA) is common in patients with chronic cough. More importantly, treatment of OSA with continuous positive airway pressure (CPAP) has led to improvement in cough for chronic cough patients. Mechanisms by which OSA therapy with CPAP can improve cough includes beneficial effects on reflux and airway inflammation.
The aim of this study is to definitively establish that CPAP therapy for treatment of OSA in chronic cough patients improves cough. While these patients with chronic cough are not routinely screened and treated for OSA, this study aims to evaluate these chronic cough patients with screening questionnaires for OSA and if necessary with polysomnography and randomize them to either CPAP or sham CPAP for 6 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cough of more than 2 month duration
- •Not active smoker with history of stoppage of smoking for more than 6 months
- •Evaluation and treatment by other providers for suspected gastroesophageal reflux disease (GERD), upper airway cough syndrome (UACS), or cough-variant asthma (CVA) for at least 1 month
- •Normal chest radiography or computed tomography (CT) scans (patients with up to 2 lung nodules less than 3 mm will be allowed if there is no history of malignancy elsewhere)
- •Normal spirometry with predicted diffusing capacity of the lung for carbon dioxide (DLCO) more than 50% predicted. Pulmonary Function Test criteria: no evidence of airflow limitation (FEV1/FVC > 0.7) or significant chest restriction (FVC > 70% predicted) with predicted DLCO more than 50% predicted
排除标准
- •Pregnancy
- •Recent pneumonia (less than 6 months)
- •Congestive heart failure, acute or chronic renal disease, jaundice or chronic liver disease, pulmonary embolism, stroke or neurodegenerative disease, malignancy
- •Use of supplemental oxygen or positive airway pressure therapy (if patients have been diagnosed with obstructive sleep apnea in the past but were non-compliant with positive airway pressure therapy, they will not be excluded)
- •Use of opiates for cough suppression (opiate use for pain suppression can be included)
- •Alcoholism, drug dependence (including chewing tobacco) or illicit drug use
- •Esophageal cancer or laryngeal surgery
- •Craniofacial abnormalities that preclude CPAP placement
结局指标
主要结局
Change in Leicester Cough Questionnaire Score
时间窗: Baseline and 6 weeks
Subjects will complete the Leicester Cough Questionnaire at the baseline and 6-week visits. The Leicester Cough Questionnaire comprises 19 items, which assess symptoms, or the impact of symptoms, over the last 2 weeks on a seven-point Likert scale. Scores in three domains (physical, psychological and social) are calculated as a mean for each domain (range 1 to 7). A total score (range 3 to 21) is also calculated by adding the domain scores together. Higher scores indicate better quality of life. The change in Leicester Cough Questionnaire score will be compared between the Straight CPAP and Sham CPAP groups
次要结局
- Nitrite/Nitrate (NOX) Level in Exhaled Breath Condensate(Baseline and 6 weeks)
- Interleukin-8 (IL-8) Level in Exhaled Breath Condensate(Baseline and 6 weeks)
- Change in Cough Frequency(Baseline and 6 weeks)
- 8 Isoprostane Level in Exhaled Breath Condensate(Baseline and 6 weeks)
- Hydrogen Peroxide (H2O2) Level in Exhaled Breath Condensate(Baseline and 6 weeks)
- Change in Gastroesophageal Reflux Disease Quality of Life (GERD-QoL) Questionnaire Score(Baseline and 6 weeks)
- Change in Leukotriene B4 (LTB4) Level in Exhaled Breath Condensate(Baseline and 6 weeks)
研究者
Krishna M. Sundar
Principal Investigator
University of Utah