NCT01667042已完成不适用
Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Airway pepsin concentration
研究概览
简要总结
This is a mechanistic research study to evaluate the relationship between cough, reflux, and aspiration in patients with systemic sclerosis (scleroderma).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients ≥ 18 years old.
- •Fulfilling the American College of Rheumatology criteria for SSc.
- •For ILD subgroup (n=6):
- •An upright chest-roentgenogram (chest x-ray) is abnormal and compatible with an interstitial lung disease.
- •HRCT of the chest confirms the presence of bilateral reticular, ground glass, and/or honeycomb abnormalities that is otherwise unexplained by an alternative process
- •The HRCT fibrosis score must be ≥
- •The total lung capacity (TLC, measured by body plethysmography) and/or the diffusing capacity of the lung for carbon monoxide (DLCO) is below the predicted normal.
- •The forced vital capacity (FVC) is reduced below the predicted normal.
- •The patient is symptomatic (i.e. dyspnea and/or a chronic cough) for more than 8 weeks that is otherwise unexplained by an alternative mechanism.
- •For No ILD subgroup (n=6):
- •No radiographic evidence of ILD on plain chest x-ray.
- •The HRCT fibrosis score, when performed) must be < 7
- •The TLC and FVC are within their predicted normal.
- •The DLCO is within the predicted normal, except when reduced in isolation by pulmonary hypertension.
排除标准
- •Active smoking within the 6 months.
- •Pneumonia or bronchitis in past 4 weeks.
- •Active acute illness such as uncontrolled heart failure, infection, or asthma.
- •Use of more than 3 liters per minute (LPM) of oxygen by nasal cannula at rest.
- •Coordinator, investigator, or clinician concerns on the patient's compliance, safety, or in ability to complete study requirements.
- •Morbid condition not expected to live more than 1 year.
- •Alternative cause or diagnosis for the patient's ILD besides SSc.
- •Pregnancy.
- •Obstructive lung disease with an FEV1 (forced expiratory volume in 1 second) to FVC ratio less than 0.7, nor radiographic evidence of emphysema on CT.
- •Planned therapeutic procedures involving the esophagus (e.g. dilation, surgery) prior to completion of study tests
结局指标
主要结局
Airway pepsin concentration
时间窗: cross-sectional
Cross-sectional comparison between airway pepsin level, cough frequency, FVC, DLCO, and CT fibrosis score
次要结局
未报告次要终点
研究者
研究点 (1)
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