Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000367640
Ethics application status
Approved
Date submitted
9/03/2023
Date registered
13/04/2023
Date last updated
13/04/2023
Date data sharing statement initially provided
13/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Can pepsin, a digestive enzyme normally found in the gastro intestinal tract, be found in the exhaled breath of people with idiopathic pulmonary fibrosis (IPF) and is nitric oxide present in excess amounts. How do these results compare with normal individuals and are results repeatable.
Scientific title
Exhaled Breath Condensate (EBC) pepsin and nitric oxide (NO) levels in Idiopathic Pulmonary Fibrosis compared with healthy controls
Secondary ID [1] 309164 0
None
Universal Trial Number (UTN)
U1111-1289-7252
Trial acronym
PEX-UIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis (IPF) 329292 0
Gastro oesophageal reflux (GER) 329293 0
Condition category
Condition code
Respiratory 326240 326240 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 326241 326241 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
IPF subjects and age matched individuals (without respiratory disease or symptoms of gastroesophageal reflux (GER)) will perform an exhaled breath condensate manoeuvre on 3 consecutive weekdays from which measurements of pepsin and nitric oxide will be made.

• EBC collection: Collection will occur using a proprietary device including a saliva trap (R-tubes, Respiratory Research, Austin Texas) using established techniques.
• Patients will be fasting for 3hr for food and 2h for water; avoid alcoholic drinks, coffee and other food or beverages containing caffeine (cola, tea, cocoa) for at least 3 h before the examination. They should also abstain from foods containing nitrates (lettuce, spinach, cabbage, sausages) and high-fat foods for at least 12h before the examination.
• Collection will take place over 10 minutes with the subjects sitting comfortably upright and exhaling through the cold R-tubes (chilled to -20degC)
• Collection time will be standardised to be between 9 and 10 am

Intervention code [1] 325612 0
Early Detection / Screening
Comparator / control treatment
Age matched subjects (without respiratory disease or symptoms of gastroesophageal reflux (GER))
Control group
Active

Outcomes
Primary outcome [1] 334109 0
Exhaled breath (EBC) pepsin levels will be measured by using a locally developed enzyme-linked immunosorbent assay (ELISA) based on a specific monoclonal antibody to porcine pepsin (Biodesign International, Saco, Maine)

The assay will be performed by one researcher who is blinded to gastroesophageal reflux diagnostic status.
Timepoint [1] 334109 0
Daily on 3 consecutive weekdays
Secondary outcome [1] 419391 0
Exhaled breath (EBC) NO
The 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 [1] 419391 0
Daily on 3 consecutive weekdays

Eligibility
Key inclusion criteria
Inclusion Criteria IPF subjects
a. American Thoracic Society / European Respiratory Society criteria for diagnosis definite or probable idiopathic pulmonary fibrosis (IPF)
b. Aged greater than or equal to 18 years with no upper limit
c. Capable of providing written informed consent

Healthy subjects
Age matched without pulmonary disease or know gastro oesophageal reflux
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria IPF Subjects
a. Previous esophageal or gastric surgery
b. Unable to discontinue anti acid medication for 7 days except aluminium hydroxide
c. Any respiratory tract infection (including upper respiratory tract infection) within 4 weeks of recruitment
d. Pregnant women
e. Unable to breathe into the EBC device

Age matched volunteers
Active pulmonary disease or gastro oesophageal reflux
Plus as per IPFsubjects

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We aim to recruit 20 subjects to each arm of the study and have taken statistical advice about this. T tests will be employed. There is an element of uncertainty around necessary numbers since although we were able to demonstrate statistically significant differences in EBC pepsin between subjects and patients with Cystic Fibrosis, that research was in 2011 and this is a different patient group.

A Bland-Altman Plot will determine test repeatability and necessary power calculations will be undertaken before the second part of this research. If necessary further recruitment will occur

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
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24229 0
Mater Adult Hospital - South Brisbane
Recruitment postcode(s) [1] 39767 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 313363 0
Hospital
Name [1] 313363 0
Mater Hospital Brisbane
Country [1] 313363 0
Australia
Primary sponsor type
Hospital
Name
Mater Hospital Brisbane
Address
Raymond Tce
South Brisbane
QLD 4101
Country
Australia
Secondary sponsor category [1] 315121 0
None
Name [1] 315121 0
Address [1] 315121 0
Country [1] 315121 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312583 0
Mater Misericordiae HREC
Ethics committee address [1] 312583 0
Ethics committee country [1] 312583 0
Australia
Date submitted for ethics approval [1] 312583 0
26/11/2020
Approval date [1] 312583 0
03/03/2021
Ethics approval number [1] 312583 0
67482

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

Contacts
Principal investigator
Name 125178 0
A/Prof Simon Bowler
Address 125178 0
Respiratory Medicine
Mater Hospital Brisbane
Raymond Tce
South Brisbane
QLD 4101
Country 125178 0
Australia
Phone 125178 0
+61 411407996
Fax 125178 0
+61 7 31638519
Email 125178 0
[email protected]
Contact person for public queries
Name 125179 0
Simon Bowler
Address 125179 0
Respiratory Medicine
Mater Hospital Brisbane
Raymond Tce
South Brisbane
QLD 4101
Country 125179 0
Australia
Phone 125179 0
+61 411407996
Fax 125179 0
+61 7 31638519
Email 125179 0
[email protected]
Contact person for scientific queries
Name 125180 0
Simon Bowler
Address 125180 0
Respiratory Medicine
Mater Hospital Brisbane
Raymond Tce
South Brisbane
QLD 4101
Country 125180 0
Australia
Phone 125180 0
+61 411407996
Fax 125180 0
+61 7 31638519
Email 125180 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
GERDQ results
Pepsin Levels
NO levels
When will data be available (start and end dates)?
1/6/2024. - 21/12/2044
Available to whom?
Researchers who provide a methodologically sound proposal at the discretion of Principal Investigator
Available for what types of analyses?
IPD meta analyses
How or where can data be obtained?
Spreadsheet access subject to approvals by Principal Investigator
[email protected]


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.