RecruitingEarly Phase 1NCT07039019

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

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


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

40 participants

Start Date

Jun 4, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • 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 Criteria6

  • 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

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Interventions

DRUGCorticosteroid

Patients take 40 mg of prednisone daily for 4 weeks to help reduce inflammation.

OTHERNo Corticosteroid

Patients do not take corticosteroid.


Locations(2)

Mount Sinai Hospital

New York, New York, United States

Mount Sinai Morningside

New York, New York, United States

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NCT07039019