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
Alfred Health
10 participants
Dec 1, 2023
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
Inclusion Criteria1
- People with complicated silicosis secondary to artificial stone
Exclusion Criteria8
- 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.
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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 for one week, and then ceased.
Locations(1)
View Full Details on ANZCTR
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ACTRN12623000622606