Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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.
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
Secondary ID [1] 309013 0
None
Universal Trial Number (UTN)
U1111-1288-5810
Trial acronym
PEX-UIP intervention
Linked study record
ACTRN12623000367640 is the linked observational study

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis (IPF) 329056 0
Gastro oesophageal reflux (GER) 329058 0
Condition category
Condition code
Respiratory 326036 326036 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 326037 326037 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 325454 0
Treatment: Other
Intervention code [2] 325455 0
Treatment: Drugs
Comparator / control treatment
Control results are those prior to introduction of bed head elevation and omeprazole, where appropriate after withholding acid suppressing medication .
Control group
Active

Outcomes
Primary outcome [1] 333897 0
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.
Timepoint [1] 333897 0
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
Primary outcome [2] 334108 0
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
Timepoint [2] 334108 0
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
Secondary outcome [1] 418648 0
Measurement of symptoms of gastro-oesophageal reflux using the GERDQ instrument
Timepoint [1] 418648 0
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

Eligibility
Key inclusion criteria
Inclusion Criteria
IPF subjects and normal controls demonstrating measurable EBC pepsin.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2023
Actual
Date of last participant enrolment
Anticipated
1/11/2023
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24061 0
Mater Adult Hospital - South Brisbane
Recruitment postcode(s) [1] 39567 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 313225 0
Hospital
Name [1] 313225 0
Mater Hospital Brisbane
Country [1] 313225 0
Australia
Primary sponsor type
Hospital
Name
Mater Misericordiae LTD
Address
Mater Hill
Raymond Tce
South Brisbane
QLD 4101
Country
Australia
Secondary sponsor category [1] 314953 0
None
Name [1] 314953 0
Address [1] 314953 0
Country [1] 314953 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312456 0
Mater Misericordiae HREC
Ethics committee address [1] 312456 0
Ethics committee country [1] 312456 0
Australia
Date submitted for ethics approval [1] 312456 0
26/11/2020
Approval date [1] 312456 0
03/03/2021
Ethics approval number [1] 312456 0
67482

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124730 0
A/Prof Simon Bowler
Address 124730 0
Respiratory Medicine Mater Hospital Brisbane Raymond Tce South Brisbane QLD 4101
Country 124730 0
Australia
Phone 124730 0
+61 411407996
Fax 124730 0
+61 7 31638519
Email 124730 0
[email protected]
Contact person for public queries
Name 124731 0
Simon Bowler
Address 124731 0
Respiratory Medicine Mater Hospital Brisbane Raymond Tce South Brisbane Q 4101
Country 124731 0
Australia
Phone 124731 0
+61 411407996
Fax 124731 0
+61 7 31638519
Email 124731 0
[email protected]
Contact person for scientific queries
Name 124732 0
Simon Bowler
Address 124732 0
Respiratory Medicine Mater Hospital Brisbane Raymond Tce South Brisbane Q 4101
Country 124732 0
Australia
Phone 124732 0
+61 411407996
Fax 124732 0
+61 7 31638519
Email 124732 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• only researchers who provide a methodologically sound proposal at the discretion of Principal Investigator

Conditions for requesting access:
• -

What individual participant data might be shared?
• GERDQ results
Pepsin Levels
NO levels
At baseline and after intervention

What types of analyses could be done with individual participant data?
• IPD meta analyses

When can requests for individual participant data be made (start and end dates)?
From:
1/6/2024
1/12/2040

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Spreadsheet access subject to approvals by Principal Investigator
[email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.