40 Participants Needed

Prednisone for Pleurisy

(PROSPECT Trial)

Recruiting at 1 trial location
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Overseen ByAxel Duval, MD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether corticosteroids, such as prednisone, can prevent fluid buildup in the lungs for individuals with non-specific pleuritis. Pleuritis can cause fluid to accumulate around the lungs, leading to discomfort and increased medical intervention. Participants will either receive corticosteroids or not, and the trial will assess whether the treatment prevents fluid recurrence or causes any side effects. Individuals diagnosed with non-specific pleuritis through a lung biopsy and lacking certain autoimmune markers may be suitable candidates. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to contribute to groundbreaking medical knowledge.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already on corticosteroids or other immunosuppressive drugs.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that prednisone, a type of steroid, does not significantly increase the risk of serious side effects. One study found that patients using steroids did not experience a substantial rise in severe problems compared to those who did not use them. Another study found that in people with severe pneumonia, steroids like prednisone reduced the need for breathing support without adding major risks.

However, some studies have identified potential downsides. For instance, in cases of tuberculous pleurisy, steroids did not improve long-term outcomes and might have caused some negative effects.

Overall, prednisone appears to be generally well-tolerated, but it can have side effects. This research study remains in its early stages, so safety information is still being collected. Participants will be closely monitored for any side effects.12345

Why do researchers think this study treatment might be promising?

Most treatments for pleurisy focus on managing symptoms with pain relievers or anti-inflammatory medications. However, prednisone is unique because it directly targets inflammation by suppressing the immune system's response. Researchers are excited about prednisone because it could provide quicker relief from pleurisy symptoms compared to standard treatments. Additionally, prednisone might help reduce the risk of complications by controlling inflammation more effectively. This potential for rapid symptom improvement and better inflammation management is what makes prednisone a promising option for pleurisy treatment.

What evidence suggests that prednisone might be an effective treatment for pleurisy?

Research has shown that medications like prednisone, a type of corticosteroid, might reduce symptoms and speed up recovery in conditions similar to pleurisy, such as tuberculous pleurisy. In some studies, patients who took prednisone recovered faster than those who did not. However, the long-term effects of these medications on lung fluid buildup remain unclear. Some research suggests that while prednisone alleviates initial symptoms, it doesn't significantly alter long-term outcomes. In this trial, one group of participants will receive prednisone to determine if it can prevent fluid from building up again in the lungs for people with non-specific pleuritis, while another group will not receive any corticosteroids.678910

Who Is on the Research Team?

UC

Udit Chaddha, MBBS

Principal Investigator

Icahn School of Medicine

Are You a Good Fit for This Trial?

This trial is for patients with non-specific pleuritis, diagnosed through a biopsy, who have experienced fluid buildup in the lungs. Participants should be available for regular clinic visits and telephone follow-ups over a 6-month period.

Inclusion Criteria

I have non-specific pleuritis and all my autoimmune tests are negative.

Exclusion Criteria

Positive autoimmune serologic workup
I have an infection in the space around my lungs.
I am currently taking corticosteroids or other immunosuppressive medications.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive corticosteroids or no treatment to evaluate the prevention of pleural effusion recurrence

6 months
In-person visits every 2 weeks for the first month, then monthly, with possible telephone follow-ups

Follow-up

Participants are monitored for pleural effusion recurrence, need for additional procedures, and potential side effects of corticosteroids

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Prednisone
Trial Overview The study is testing if corticosteroids can prevent recurrence of lung fluid buildup in pleurisy patients. It involves two groups: one receiving corticosteroids (standard care) and another not receiving them, to compare outcomes.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Patients with CorticosteroidsExperimental Treatment1 Intervention
Group II: Patients with No CorticosteroidsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+

Citations

Corticosteroids for tuberculous pleurisy - PMC - PubMed CentralCorticosteroids may reduce the time to resolution of the symptoms of TB pleurisy and the time to resolution of the pleural effusion on chest X‐ray (low ...
Corticosteroids in the Treatment of Tuberculous PleurisyAlthough a statistically significant improvement in symptoms occurred earlier in the prednisone group (8 weeks) than in the placebo group (12 weeks), between- ...
A retrospective study evaluating the effect of Prednisolone on ...Conclusion: Whilst Prednisolone led to statistically significant reductions in pleural opacification, end of treatment opacification was similar in both groups.
The efficacy and safety of adjunctive corticosteroids in ...Our results suggest that adjunctive corticosteroid use does not improve the long-term efficacy of tuberculous pleurisy and might lead to ...
Prednisone for Pleurisy (PROSPECT Trial)This research study aims to evaluate whether corticosteroids help prevent the recurrence of pleural effusions in patients with non-specific pleuritis ...
The efficacy and safety of adjunctive corticosteroids in ...Our results suggest that adjunctive corticosteroid use does not improve the long-term efficacy of tuberculous pleurisy and might lead to detrimental adverse ...
Effect of Oral Prednisolone on Symptom Duration and Severity ...The primary outcomes were duration of moderately bad or worse cough (0 to 28 days; minimal clinically important difference, 3.79 days) and mean severity of ...
SAFETY AND EFFICACY OF STEROIDS IN PATIENTS ...CONCLUSIONS: Use of steroid in patients hospitalized with severe pneumonia showed decreased mortality and need for intubation with no ...
Study of the Feasibility and Efficacy of PrednisonE for Non- ...This research study aims to evaluate whether corticosteroids help prevent the recurrence of pleural effusions in patients with non-specific pleuritis diagnosed ...
Comparative effect of different corticosteroids in severe ...The results indicate that corticosteroids do not significantly increase the risk of SAEs, which is consistent with previous research [8, 9].
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