Recruiting
Early Phase 1

Corticosteroids

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07039019

Conditions

Pleuritis, Non-specific

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Corticosteroid

No Corticosteroid

Study Details

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

Study ID

NCT07039019

Start date

May 29, 2025

Status verified date

Jun, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Patients with Corticosteroids

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.

active comparator: Patients with No Corticosteroids

Patients will not receive any corticosteroids.

Interventions

Corticosteroid

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

No Corticosteroid

Patients do not take corticosteroid.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Udit Chaddha, MBBS

udit.chaddha@mssm.edu

Mount Sinai Morningside

Recruiting

New York, New York, United States, 10029

Contacts

Udit Chaddha, MBBS

udit.chaddha@mssm.edu

Principal Investigator:

Udit Chaddha

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-06-25.