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

Conditions

• Pleuritis, Non-specific

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Corticosteroid — DRUG
  Patients take 40 mg of prednisone daily for 4 weeks to help reduce inflammation.
• No Corticosteroid — OTHER
  Patients do not take corticosteroid.

Study Details

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.

Key Dates

Start date

Jun 4, 2025

Status verified

Jun 2025

Primary completion

Nov 19, 2026

Completion

Nov 19, 2026

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

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.

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 ]

Central Contacts

• Axel Duval, MD
  212-824-8546
  [email protected]

Locations (2)

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