The Prevalence of Gastro-oesophageal Reflux in Chronic Lung Disease

This study has been completed.
Sponsor:
Collaborator:
University of Melbourne
Information provided by (Responsible Party):
Bayside Health
ClinicalTrials.gov Identifier:
NCT00697177
First received: September 9, 2005
Last updated: February 12, 2013
Last verified: September 2005
  Purpose

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.


Condition Phase
Chronic Obstructive Pulmonary Disease
Bronchiectasis
Phase 1
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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.

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • Prevalence of GOR [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: July 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adults with COPD and bronchiectasis

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • diagnosis of asthma, cystic fibrosis, interstitial lung disease
  • known hiatus hernia, oesophageal varices, obstructive sleep apnoea
  • medically unstable for exercise
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697177

Locations
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bayside Health
University of Melbourne
Investigators
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
  More Information

No publications provided

Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT00697177     History of Changes
Other Study ID Numbers: 106/05, CTG008/05
Study First Received: September 9, 2005
Last Updated: February 12, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Bayside Health:
Gastro-oesophageal reflux
24 hour oesophageal pH monitoring
Physiotherapy Airway clearance techniques
Exercise

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchiectasis
Gastroesophageal Reflux
Respiratory Tract Diseases
Bronchial Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 19, 2014