Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00697177




Registration number
NCT00697177
Ethics application status
Date submitted
9/09/2005
Date registered
13/06/2008
Date last updated
15/02/2013

Titles & IDs
Public title
The Prevalence of Gastro-oesophageal Reflux in Chronic Lung Disease
Scientific 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.
Secondary ID [1] 0 0
CTG008/05
Secondary ID [2] 0 0
106/05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
Bronchiectasis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Prevalence of GOR
Timepoint [1] 0 0
12 months

Eligibility
Key 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
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* diagnosis of asthma, cystic fibrosis, interstitial lung disease
* known hiatus hernia, oesophageal varices, obstructive sleep apnoea
* medically unstable for exercise

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2009
Sample size
Target
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00697177
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Annemarie L Lee, BPhys, MPhys
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00697177