RecruitingPhase 2ACTRN12623000622606

The STOP Study: Silicosis Treatment Of Prednisolone

The Silicosis Treatment Of Prednisolone (STOP) Study: assessing the effectiveness of Prednisolone on respiratory function in adults with silicosis


Sponsor

Alfred Health

Enrollment

10 participants

Start Date

Dec 1, 2023

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

Silicosis is a serious and irreversible lung disease caused by inhaling fine silica dust — a significant risk for tradespeople who work with engineered stone benchtops. Artificial stone-associated silicosis can progress rapidly and cause severe scarring and inflammation of the lung tissue. Currently there are very few effective treatments. This pilot study is testing whether prednisolone — a common anti-inflammatory steroid — can reduce lung inflammation in people with complicated silicosis from artificial stone who have already stopped working with silica. Participants will take 25mg of prednisolone daily for three months, with careful monitoring for side effects and markers of disease activity before and after treatment. You may be eligible if you are between 18 and 75 years old and have been diagnosed with complicated silicosis from artificial stone exposure and are no longer exposed to silica dust. People with diabetes, tuberculosis, a history of serious infections, autoimmune conditions, asthma, or those already taking steroids or immunosuppressants would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.


Locations(1)

The Alfred - Melbourne

VIC, Australia

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ACTRN12623000622606


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