Pleuritis, Non-specificEarly Phase 1PROSPECTNCT07039019
Study of the Feasibility and Efficacy of PrednisonE for Non-specifiC pleuriTis
A Early Phase 1 study testing Corticosteroid and No Corticosteroid in people with Pleuritis, Non-specific, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleuritis, Non-specific
- What is being tested?
- Corticosteroid and No Corticosteroid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 May 2025to 30 Jun 2027
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Udit Chaddha, MBBS, udit.chaddha@mssm.edu
Axel Duval, MD, axel.duval@mountsinai.org
- Recruiting
Mount Sinai Morningside
New York, New York, 10029
Udit Chaddha, MBBS, udit.chaddha@mssm.edu
Axel Duval, MD, axel.duval@mountsinai.org
About this study
Official title: Pilot, RandOmized 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.
- Conditions
- Pleuritis, Non-specific
- Being tested
- Corticosteroid, No Corticosteroid
- Medical subject headings
- Pleurisy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticosteroidDrug
Also called Prednisone
Patients take 40 mg of prednisone daily for 4 weeks to help reduce inflammation.
No CorticosteroidOther
Patients do not take corticosteroid.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Corticosteroid |
| Patients with No Corticosteroids | Active comparator | Patients will not receive any corticosteroids. Receives: Other: No Corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients screened
Screened defined as how many patients are evaluated for participation
Measured: 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
Measured: 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
Measured: every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months
Secondary outcomes (1)
Rate of recurrence
Incidence of recurrent pleural effusions attributable to symptoms requiring an intervention
Measured: every 2 weeks after pleuroscopy for the first 4 weeks, and then monthly up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start29 May 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleuritis, Non-specificStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Udit Chaddha, Icahn School of Medicine at Mount Sinai
- Investigators
- Udit Chaddha, MBBS, Principal investigator, Icahn School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039019
- Sponsor's protocol ID
- STUDY-25-00427
- Acronym
- PROSPECT
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.