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

NCT07039019 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: STUDY-25-00427
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Pleuritis, Non-specific

Outcome Measures

Primary Outcomes (3)

• Number of patients screened

  Screened defined as how many patients are evaluated for participation

  every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months

• Number of patients enrolled

  Enrolled defined as how many screened patients actually join the study

  every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months

• Number of patients retained

  Retention defined as how many enrolled patients continue participating over time

  every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months

Secondary Outcomes (1)

• Rate of recurrence

  every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months

Study Arms (2)

Patients with Corticosteroids

EXPERIMENTAL

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.

Drug: Corticosteroid

Patients with No Corticosteroids

ACTIVE COMPARATOR

Patients will not receive any corticosteroids.

Other: No Corticosteroid

Interventions

Corticosteroid DRUG

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

Also known as: Prednisone

Patients with Corticosteroids

No Corticosteroid OTHER

Patients do not take corticosteroid.

Patients with No Corticosteroids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (2)

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Mount Sinai Morningside

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Pleurisy

Interventions

Adrenal Cortex Hormones; Prednisone

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Udit Chaddha, MBBS

  Icahn School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Axel Duval, MD

CONTACT

212-824-8546; axel.duval@mountsinai.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: May 29, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Proposals should be directed to udit.chaddha@mssm.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (link to be determined).

Locations

US (2)