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Sponsors and Collaborators: |
Bayside Health University of Melbourne |
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Information provided by: | Bayside Health |
ClinicalTrials.gov Identifier: | NCT00697177 |
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.
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | 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. |
Estimated Enrollment: | 54 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | October 2006 |
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:
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:
All subjects will maintain a 24 hour diary recording meals, positions, medications and physiotherapy airway clearance sessions.
During the 24 hour oesophageal pH monitoring, the following interventions will be completed:
On study completion, subjects will return for removal of the oesophageal probe and retrieval of the digitrapper. Oesophageal pH study data will be downloaded onto a computer file for analysis. Oral intake, medications, symptoms, positioning, airway clearance and exercise will be extracted from subjective diaries that the subjects maintain, together with quality of life questionnaires and compared with pH recording data. Saliva and sputum pepsin assay results will be correlated with oesophageal pH monitoring data.
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Annemarie L Lee, BPhys, MPhys | 92-762-000 ext 3450 | Annemarie.Lee@alfred.org.au |
Contact: Brenda M Button, DPhysio, PhD | 92-762-000 ext 3450 | b.button@alfred.org.au |
Australia, Victoria | |
Alfred Hospital | Recruiting |
Melbourne, Victoria, Australia, 3004 | |
Contact: Brenda M Button, DPhysio, PhD 92-762-000 ext 3450 b.button@alfred.org.au | |
Contact: Annemarie L Lee, BPhys, MPhys 92-762-000 ext 3450 Annemarie.Lee@alfred.org.au | |
Principal Investigator: Annemarie L Lee, BPhys, MPhys | |
Sub-Investigator: Brenda M Button, DPhysio, PhD | |
Sub-Investigator: John W Wilson, MBBS, PhD |
Principal Investigator: | Annemarie L Lee, BPhys, MPhys | University of Melbourne |
Principal Investigator: | Brenda M Button, DPhysio, PhD | The Alfred |
Study Director: | John W Wilson, MBBS, PhD | The Alfred |
Study ID Numbers: | 106/05, CTG008/05 |
Study First Received: | September 9, 2005 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00697177 |
Health Authority: | Australia: Human Research Ethics Committee |
Gastro-oesophageal reflux 24 hour oesophageal pH monitoring Physiotherapy Airway clearance techniques Exercise |
Esophageal disorder Bronchiectasis Gastrointestinal Diseases Respiration Disorders Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders |
Lung Diseases, Obstructive Digestive System Diseases Respiratory Tract Diseases Lung Diseases Esophageal Diseases Pulmonary Disease, Chronic Obstructive |
Bronchial Diseases |