Study of the Feasibility and Efficacy of PrednisonE for Non-specifiC pleuriTis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Corticosteroid, No Corticosteroid.
- Who it may be relevant to
- Registry conditions: Pleuritis, Non-specific. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot, RandOmized Study of the Feasibility and Efficacy of PrednisonE for Non-specifiC pleuriTis
Overview
This research study aims to evaluate whether corticosteroids help prevent the recurrence of pleural effusions in patients with non-specific pleuritis diagnosed through pleural biopsy. It can lead to recurrent fluid buildup in the lungs, causing discomfort and requiring additional medical interventions. There is no established treatment to prevent recurrence, and this study seeks to determine whether steroids reduce fluid buildup or cause complications. There will be two groups: one receiving corticosteroids (standard of care in the institution) and one not receiving corticosteroids (intervention group). The participation will last approximately 6 months, with in-person visits every 2 weeks for the first month, then monthly, along with possible telephone follow-ups. The study will monitor for pleural effusion recurrence, need for additional procedures, and potential side effects of corticosteroids. This is a pilot study. Although there are forty people expected to take part in this research study based on institutional data, the number of patients included in the study will be determined by the number of patients with non-specific pleuritis diagnosed during the study period.
Interventions
- Drug Corticosteroid
Patients take 40 mg of prednisone daily for 4 weeks to help reduce inflammation. - Other No Corticosteroid
Patients do not take corticosteroid.
Primary outcome measures
- Number of patients screened [Time frame: every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months]
- Number of patients enrolled [Time frame: every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months]
- Number of patients retained [Time frame: every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months]
Secondary outcome measures (1)
- Rate of recurrence [Time frame: every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months]
Eligibility criteria
Inclusion criteria
- All adult patients with diagnosis of non-specific pleuritis as determined by pleural biopsy with a negative serologic autoimmune profile (ANA, ANCA, anti-DS DNA, anti-SS A/B, anti-centromere, RF, anti-CCP) are eligible
Exclusion criteria
- Chronic/fibrinous pleuritis
- Positive autoimmune serologic workup
- A contraindication to corticosteroids
- Empyema
- Patients already receiving corticosteroids or other immunosuppressive medications for any other indication
- Inability to obtain informed consent due to cognitive, neurologic or psychiatric impairment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- Mount Sinai Hospital — New York
- Mount Sinai Morningside — New York
Identifiers
NCT: NCT07039019 · STUDY-25-00427