None listed
Conditions
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.
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.
Sponsors
Alfred Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
People with complicated silicosis secondary to artificial stone
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.
Outcome results
None listed