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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-04

Study Completion Date

2026-11-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Pleuritis, Non-specific

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Corticosteroid

Intervention Type DRUG

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

Patients with No Corticosteroids

Patients will not receive any corticosteroids.

Group Type ACTIVE_COMPARATOR

No Corticosteroid

Intervention Type OTHER

Patients do not take corticosteroid.

Interventions

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Corticosteroid

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

Intervention Type DRUG

No Corticosteroid

Patients do not take corticosteroid.

Intervention Type OTHER

Other Intervention Names

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Prednisone

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No