Brief Title
The Prevalence of Gastro-oesophageal Reflux in Chronic Lung Disease
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.
Brief Summary
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.
Detailed Description
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:
- number of reflux episodes,
- % reflux time,
- number of long episodes > 5 minutes,
- duration of the longest episode
- DeMeester score, a weighted overall score of gastro-oesophageal function.
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:
1. Standard Spirometry. Measurement of spirometry will be performed according to the GINA
guidelines.
2. Pepsin Assay. Four sets of samples per subject of sputum and saliva for pepsin analysis
will be collected during the study: at study commencement, during the airway clearance
session, upon rising in the morning and post exercise testing. EnzChek Protease Assay
kit will be used for analysis.
3. Airway clearance techniques. Each subject with excessive secretions will perform PEP
therapy, completing 8 cycles of 10 breaths, 2 forced expirations (huffs) and coughing
using a PariPEP device.
4. Exercise testing. Each subject will complete 2 x Six-Minute-Walk Tests and 3 x Grocery
Shelving Tests according to the test protocols.
5. Actigraphy. Each subject will wear a wrist actigraph on their dominant wrist which will
record timing of activity and inactivity, so that sleep quality can be extrapolated.
Subjects will also complete a Pittsburgh Sleep Diary during the study.
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.
Study Type
Observational
Primary Outcome
Prevalence of GOR
Condition
Chronic Obstructive Pulmonary Disease
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
75
Start Date
July 2005
Completion Date
June 2009
Primary Completion Date
June 2009
Eligibility 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
Gender
All
Ages
20 Years - 80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Annemarie L Lee, BPhys, MPhys, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00697177
Organization ID
106/05
Secondary IDs
CTG008/05
Responsible Party
Sponsor
Study Sponsor
Bayside Health
Collaborators
University of Melbourne
Study Sponsor
Annemarie L Lee, BPhys, MPhys, Principal Investigator, University of Melbourne
Verification Date
September 2005