Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07039019

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mount Sinai Hospital, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corticosteroid

Drug

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

Other names: Prednisone

No Corticosteroid

Other

Patients do not take corticosteroid.

Primary outcomes

  1. Number of patients screened

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

    Screened defined as how many patients are evaluated for participation

  2. Number of patients enrolled

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

    Enrolled defined as how many screened patients actually join the study

  3. Number of patients retained

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

    Retention defined as how many enrolled patients continue participating over time

Secondary outcomes

  1. Rate of recurrence

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

    Incidence of recurrent pleural effusions attributable to symptoms requiring an intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Axel Duval, MD

CONTACT

[email protected]

212-824-8546

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Acronym: PROSPECT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2025
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.