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临床试验/NCT00697177
NCT00697177已完成不适用

The Prevalence of Gastro-oesophageal Reflux in Chronic Obstructive Pulmonary Disease and Bronchiectasis and the Effects of Medications, Physiotherapy Airway Clearance Techniques and Exercise on Gastro-oesophageal Function.

Bayside Health1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2005年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
Prevalence of GOR

研究概览

简要总结

Gastric reflux into the oesophagus may further lung damage in respiratory disease. The proportion of adults with chronic lung disease and gastric reflux is unknown. Adults with this disease regularly complete physiotherapy but the contribution of physiotherapy to reflux is unknown. This study will measure gastric reflux in adults with chronic lung disease, using 24 hour acid monitoring. It is anticipated that approximately 50% of adults with chronic lung disease will have gastric reflux. After monitoring, the number of gastric reflux episodes will be calculated. The results will identify the extent of the gastric reflux problem in these patients and will enable appropriate medical treatment and modifications to physiotherapy, which may improve lung function and quality of life.

详细描述

Research plan:

Fifty-four subjects will be recruited from the Department of AIRMED outpatient clinics at the Alfred Hospital, Melbourne. Subjects will be considered eligible if they have a diagnosis of COPD or bronchiectasis and are clinically stable.

Subjects who give their consent will undergo the following measures:

  1. Demographic data including age, gender, BMI, prescribed medications at time of study.
  2. Structured symptom questionnaire A reliable, valid structured symptom questionnaire which will assess symptomatic GOR.
  3. Health -related quality of life and sleep quality Quality of life will be recorded using a Short form-36, St Georges's Respiratory Questionnaire and Quality of Life in Reflux and Dyspepsia questionnaire.
  4. Dual-channel 24 hour oesophageal pH monitoring

Ambulatory 24 hour oesophageal pH monitoring will be undertaken by all subjects using dual-channel oesophageal pH monitoring equipment. The distal antimony-tipped probe will be sited 5cm above the upper portion of the lower oesophageal sphincter (distal sensor) with the proximal sensor sited 15cm above the distal sensor. The probe is attached to the digitrapper and will record oesophageal pH for 24 hours. The subject will be instructed to activate the digitrapper's three event buttons recording start and finish time of meals, supine versus upright posture and GOR symptoms. The following indices will be measured in the distal and proximal oesophagus:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Chronic obstructive pulmonary disease according to GOLD classification
  • Diagnosis of Bronchiectasis
  • Medically stable, without hospital admission in month prior to study

排除标准

  • diagnosis of asthma, cystic fibrosis, interstitial lung disease
  • known hiatus hernia, oesophageal varices, obstructive sleep apnoea
  • medically unstable for exercise

结局指标

主要结局

Prevalence of GOR

时间窗: 12 months

次要结局

未报告次要终点

研究者

发起方
Bayside Health
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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