Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000622606
Ethics application status
Approved
Date submitted
6/03/2023
Date registered
7/06/2023
Date last updated
30/05/2024
Date data sharing statement initially provided
7/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The STOP Study: Silicosis Treatment Of Prednisolone
Scientific title
The Silicosis Treatment Of Prednisolone (STOP) Study: assessing the effectiveness of Prednisolone on respiratory function in adults with silicosis
Secondary ID [1] 309138 0
nil
Universal Trial Number (UTN)
Trial acronym
STOP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Silicosis 329236 0
Condition category
Condition code
Respiratory 326194 326194 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral tablet prednisolone 25mg once daily will be prescribed for three months. After three months the dose will be weaned, with a tapering dose of 15mg once daily for a week, followed by 5mg once daily for one week, and then ceased.
Intervention code [1] 325586 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334070 0
Change in forced vital capacity (FVC) (absolute and % predicted) using spirometry (lung function tests)
Timepoint [1] 334070 0
FVC will be measured as change from baseline to post-treatment, measured at three months on treatment. This is the primary timepoint.
FVC will also be measured at six months post cessation of treatment as a secondary timepoint.
Primary outcome [2] 334071 0
Change in forced expiratory volume in 1 second (FEV1) (absolute and % predicted) using spirometry (lung function tests)
Timepoint [2] 334071 0
FEV1 will be measured as change from baseline to post-treatment, measured at three months on treatment. This is the primary timepoint.
FEV1 will also be measured at six months post cessation of treatment as a secondary timepoint.
Primary outcome [3] 334072 0
Change in diffusing capacity of the lungs for carbon monoxide (DLCO) (absolute and % predicted) using single-breath technique.
Timepoint [3] 334072 0
DLCO will be measured as change from baseline to post-treatment, measured at three months on treatment. This is the primary timepoint.
DLCO will also be measured at six months post cessation of treatment as a secondary timepoint.
Secondary outcome [1] 419267 0
Quantitative change in inflammatory activity using maximum standardised uptake volume (SUVmax) on positron emission tomography (PET) scan.
Change in PET scans will also be assessed visually.
Timepoint [1] 419267 0
SUVmax will be measured as change from baseline to post-treatment, measured at three months on treatment.
Secondary outcome [2] 419268 0
Change in blood autoimmune markers. These include
ANA (antinuclear antibody)
ENA (extractable nuclear antigen antibodies)
Timepoint [2] 419268 0
These will be measured at baseline, and at three months on treatment, and at six months post cessation of treatment.
Analyses will be performed to determine the change from baseline to three months on treatment, and change from baseline to six months post cessation of treatment.
Secondary outcome [3] 419269 0
Change in health-related quality of life measures: St Georges Respiratory Questionnaire
Timepoint [3] 419269 0
These will be measured at baseline, and at three months on treatment, and at six months post cessation of treatment.
Analyses will be performed to determine the change from baseline to three months on treatment, and change from baseline to six months post cessation of treatment.
Secondary outcome [4] 419270 0
Adverse events. These include:
1. Serious Adverse Events
2. Sudden Unexpected Serious Adverse Reactions
3. Adverse events which are not SAEs or SUSARs.

Adverse reactions will be reported according to the MedRA terms (Medical Dictionary for Regulatory Activities).
The following will be specifically monitored at each visit:
Cardiac – Heart rate and blood pressure will be assessed using a digital sphygmomanometer.
Endocrine – Blood sugar levels will be assessed by blood draw, and weight will be monitored at each visit.
Gastrointestinal – Any clinical reports of reflux will be recorded.
Infections - Any clinical reports of infection will be recorded.
Nervous system – Any clinical reports of insomnia or mood changes will be recorded.
Timepoint [4] 419270 0
Adverse events will be assessed at six-weekly visits following commencement of the treatment, that is:
Week 6, Week 12, Week 18, and then again at Week 42
In addition, participants can report adverse events continuously throughout the trial.
Secondary outcome [5] 421866 0
Change in inflammatory blood markers. These include:
ACE (angiotensin converting enzyme) levels
ESR (erythrocyte sedimentation rate)
CRP (c-reactive protein)
Timepoint [5] 421866 0
These will be measured at baseline, and at three months on treatment, and at six months post cessation of treatment.
Analyses will be performed to determine the change from baseline to three months on treatment, and change from baseline to six months post cessation of treatment.

Eligibility
Key inclusion criteria
People with complicated silicosis secondary to artificial stone
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with any of the following will be excluded:
(i) ongoing potential exposure to silica (i.e., still working in the stone industry),
(ii) diabetes mellitus (either previously diagnosed or >5.7% HbA1c at screening),
(iii) tuberculosis,
(iv) any history of serious infections,
(v) any autoimmune conditions,
(vi) on Prednisolone of any dose or other immunosuppressants for other conditions,
(vii) those with asthma confirmed with a positive bronchodilator challenge or positive mannitol test.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applied
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/06/2023
Actual
1/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24208 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 39741 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 313340 0
Hospital
Name [1] 313340 0
Alfred Health
Country [1] 313340 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Rd
Melbourne
VIC 3004
Country
Australia
Secondary sponsor category [1] 315932 0
None
Name [1] 315932 0
Address [1] 315932 0
Country [1] 315932 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312562 0
Alfred Health
Ethics committee address [1] 312562 0
55 Commercial Rd
Melbourne
VIC 3004
Ethics committee country [1] 312562 0
Australia
Date submitted for ethics approval [1] 312562 0
24/03/2023
Approval date [1] 312562 0
12/05/2023
Ethics approval number [1] 312562 0
HREC/94652/Alfred-2023
Ethics committee name [2] 312983 0
Alfred Health
Ethics committee address [2] 312983 0
55 Commercial Rd
Melbourne
VIC 3004
Ethics committee country [2] 312983 0
Australia
Date submitted for ethics approval [2] 312983 0
24/03/2023
Approval date [2] 312983 0
Ethics approval number [2] 312983 0

Summary
Brief summary
This is a pilot study which aims to assess the response to the use of prednisolone in people with artificial stone associated silicosis. The pilot study will assess safety, feasibility, and explore the effect of prednisolone on clinical outcomes (markers of disease activity) before and after treatment.
Participants will include people with artificial stone-associated silicosis who have elevated indicator(s) of inflammation despite cessation of exposure to silica dust.
Participants will be treated with 25mg prednisolone daily for three months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125098 0
Dr Hayley Barnes
Address 125098 0
Department of Respiratory Medicine
Alfred Health
55 Commercial Rd
Melbourne VIC 3004
Country 125098 0
Australia
Phone 125098 0
+61 390767617
Fax 125098 0
Email 125098 0
h.barnes@alfred.org.au
Contact person for public queries
Name 125099 0
Dr Hayley Barnes
Address 125099 0
Department of Respiratory Medicine
Alfred Health
55 Commercial Rd
Melbourne VIC 3004
Country 125099 0
Australia
Phone 125099 0
+61 390762000
Fax 125099 0
Email 125099 0
h.barnes@alfred.org.au
Contact person for scientific queries
Name 125100 0
Dr Hayley Barnes
Address 125100 0
Department of Respiratory Medicine
Alfred Health
55 Commercial Rd
Melbourne VIC 3004
Country 125100 0
Australia
Phone 125100 0
+61 390767617
Fax 125100 0
Email 125100 0
h.barnes@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Age within 5 years, gender, diagnosis, lung function test results, blood test results, PET scan quantitative analysis
When will data be available (start and end dates)?
From May 2025 and available for 7 years
Available to whom?
Researchers with a methodologically sound proposal, with the proposal approved by the Alfred Ethics Board and the study investigators.
Available for what types of analyses?
IPD meta-analyses
How or where can data be obtained?
Contact the principal investigator at h.barnes@alfred.org.au


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.