Study of the Feasibility and Efficacy of PrednisonE for Non-specifiC pleuriTis

Phase 1

Recruiting

• Conditions: Pleuritis, Non-specific
• Interventions: Drug: Corticosteroid; Other: No Corticosteroid

• Registration Number: NCT07039019
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-04
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Primary Completion: 2026-11-19
• Study Completion: 2026-11-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with Corticosteroids	Corticosteroid	Standard of care (corticosteroids) as per institutional practice. If the treatment is effective, patients continue for another 4 weeks while taking medication to prevent infections. If it's not effective, they begin a gradual dose reduction until stopping.
Patients with No Corticosteroids	No Corticosteroid	Patients will not receive any corticosteroids.

Primary Outcome Measures

Name	Time	Method
Number of patients screened	every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months	Screened defined as how many patients are evaluated for participation
Number of patients enrolled	every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months	Enrolled defined as how many screened patients actually join the study
Number of patients retained	every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months	Retention defined as how many enrolled patients continue participating over time

Secondary Outcome Measures

Name	Time	Method
Rate of recurrence	every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months	Incidence of recurrent pleural effusions attributable to symptoms requiring an intervention

Trial Locations

Locations (2)

Mount Sinai Hospital; 🇺🇸 New York, New York, United States

Mount Sinai Morningside; 🇺🇸 New York, New York, United States