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Trial registered on ANZCTR
Registration number
ACTRN12623000430639
Ethics application status
Approved
Date submitted
17/02/2023
Date registered
28/04/2023
Date last updated
28/04/2023
Date data sharing statement initially provided
28/04/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Do methods to reduce gastro esophageal reflux (GER) including sleeping posture (elevation of the head of the bad) and use of protein pump inhibitor medications, also reduce pepsin (normally not found in the lung) in the exhaled breath of people with GER.
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Scientific title
Can measures to reduce GER, including sleeping posture (elevation of the head of the bed) and use of protein pump inhibitors medication, reduce levels of pepsin in exhaled breath condensate (EBC) of people with GER
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Secondary ID [1]
309013
0
None
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Universal Trial Number (UTN)
U1111-1288-5810
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Trial acronym
PEX-UIP intervention
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Linked study record
ACTRN12623000367640 is the linked observational study
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Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis (IPF)
329056
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Gastro oesophageal reflux (GER)
329058
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Condition category
Condition code
Respiratory
326036
326036
0
0
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Other respiratory disorders / diseases
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Oral and Gastrointestinal
326037
326037
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
1. Withholding any anti-acid therapy for 7 days except aluminium hydroxide, then:
2. Elevation of the head of the bed during sleeping by the provision of two 15cm high chocks under each side of the head of the bed for 2 days. Subjects will photograph after set up and share with investigators to exclude difficulties and confirm adherence to measure. This will be followed by:
3. Oral omeprazole 20mg twice daily for 7 days. Returned pill bottles / pill count will be used to confirm compliance.
A washout period of one week will occur between interventions
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Intervention code [1]
325454
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Treatment: Other
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Intervention code [2]
325455
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Treatment: Drugs
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Comparator / control treatment
Control results are those prior to introduction of bed head elevation and omeprazole, where appropriate after withholding acid suppressing medication .
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Control group
Active
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Outcomes
Primary outcome [1]
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Exhaled breath condensate (EBC) levels of pepsin measured by a locally developed enzyme-linked immunosorbent assay (ELISA) based on a specific monoclonal antibody to porcine pepsin.
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Assessment method [1]
333897
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Timepoint [1]
333897
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This will occur at baseline (3 collections) and immediately after (ie next day) 2 days of sleeping with the head of bed elevated and immediately after 7 days of twice daily omeprazole 20mg
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Primary outcome [2]
334108
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EBC levels of nitric oxide end products are nitrite and nitrate (NOx), and their concentrations can be measured in EBC by simple Griess reaction supplemented with the reduction of nitrate to nitrite by reduced nicotinamide adenine dinucleotide phosphate (NADPH)-dependent reductase
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Assessment method [2]
334108
0
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Timepoint [2]
334108
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Immediately after interventions as above ie at baseline (3 collections) and immediately after (ie next day) 2 days of sleeping with the head of bed elevated and immediately after 7 days of twice daily omeprazole 20mg
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Secondary outcome [1]
418648
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Measurement of symptoms of gastro-oesophageal reflux using the GERDQ instrument
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Assessment method [1]
418648
0
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Timepoint [1]
418648
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Baseline (3 collections) and immediately after 7 days of withholding anti-acid medications and immediately after 2 days of sleeping with the head of bed elevated and immediately after 7 days of twice daily omeprazole 20mg
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Eligibility
Key inclusion criteria
Inclusion Criteria
IPF subjects and normal controls demonstrating measurable EBC pepsin.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Any subject without measurable EBC pepsin. Subjects with previous oesophageal or gastric surgery or those unable to withhold acid suppressive medication or with recent respiratory tract infection (2 weeks) will be excluded
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Paired t tests will compare pre and post intervention levels of pepsin and NO. We have no data on outcomes and variance so determining numbers is difficult
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
15/05/2023
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Actual
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Date of last participant enrolment
Anticipated
1/11/2023
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Actual
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Date of last data collection
Anticipated
1/12/2023
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
24061
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Mater Adult Hospital - South Brisbane
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Recruitment postcode(s) [1]
39567
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4101 - South Brisbane
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Funding & Sponsors
Funding source category [1]
313225
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Hospital
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Name [1]
313225
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Mater Hospital Brisbane
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Address [1]
313225
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Mater Hospital
Raymond Tce
South Brisbane
QLD 4101
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Country [1]
313225
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Australia
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Primary sponsor type
Hospital
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Name
Mater Misericordiae LTD
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Address
Mater Hill
Raymond Tce
South Brisbane
QLD 4101
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Country
Australia
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Secondary sponsor category [1]
314953
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None
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Name [1]
314953
0
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Address [1]
314953
0
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Country [1]
314953
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
312456
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Mater Misericordiae HREC
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Ethics committee address [1]
312456
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Level 2 Aubigny Place
Mater Hill
QLD 4101
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Ethics committee country [1]
312456
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Australia
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Date submitted for ethics approval [1]
312456
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26/11/2020
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Approval date [1]
312456
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03/03/2021
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Ethics approval number [1]
312456
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67482
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Summary
Brief summary
This study will investigate whether in subjects (people with idiopathic pulmonary fibrosis (IPF) and aged matched controls without lung or gastroesophageal disease) who are found to have pepsin (an enzyme normally found in the stomach and not in the lungs) in the exhaled breath (EBC), simple postural measures and common acid suppression medication can reduce the level of pepsin in the EBC
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
124730
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A/Prof Simon Bowler
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Address
124730
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Respiratory Medicine
Mater Hospital Brisbane
Raymond Tce
South Brisbane
QLD 4101
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Country
124730
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Australia
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Phone
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+61 411407996
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Fax
124730
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+61 7 31638519
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Email
124730
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[email protected]
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Contact person for public queries
Name
124731
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A/Prof Simon Bowler
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Address
124731
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Respiratory Medicine
Mater Hospital Brisbane
Raymond Tce
South Brisbane
Q 4101
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Country
124731
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Australia
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Phone
124731
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+61 411407996
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Fax
124731
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+61 7 31638519
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Email
124731
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[email protected]
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Contact person for scientific queries
Name
124732
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A/Prof Simon Bowler
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Address
124732
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Respiratory Medicine
Mater Hospital Brisbane
Raymond Tce
South Brisbane
Q 4101
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Country
124732
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Australia
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Phone
124732
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+61 411407996
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Fax
124732
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+61 7 31638519
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Email
124732
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
GERDQ results
Pepsin Levels
NO levels
At baseline and after intervention
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When will data be available (start and end dates)?
1/6/2024
1/12/2040
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Available to whom?
only researchers who provide a methodologically sound proposal at the discretion of Principal Investigator
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Available for what types of analyses?
IPD meta analyses
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How or where can data be obtained?
Spreadsheet access subject to approvals by Principal Investigator
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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