Roflumilast for Sarcoidosis

3
Effectiveness
3
Safety
University of Cincinnati, Cincinnati, OH
Roflumilast - Drug
Eligibility
18+
All Sexes
Eligible conditions
Sarcoidosis

Study Summary

Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS)

See full description

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Roflumilast will improve 1 primary outcome, 2 secondary outcomes, and 1 other outcome in patients with Sarcoidosis. Measurement will happen over the course of one year.

One year
Changes in quality of life
one year
Change in FVC
Reduction in number of episodes of acute exacerbation
Safety

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Side Effects for

All Participants
Pulmonary Exacerbation
8%
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT03073798) in the All Participants ARM group. Side effects include: Pulmonary Exacerbation with 8%.

Trial Design

2 Treatment Groups

Placebo
Roflumilast
Placebo group

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Roflumilast is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Roflumilast
Drug
Roflumilast
Placebo
Drug
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Roflumilast
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: one year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly one year for reporting.

Who is running the study

Principal Investigator
R. P. B.
Prof. Robert P Baughman, Professor of Medicine
University of Cincinnati

Closest Location

University of Cincinnati - Cincinnati, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients with sarcoidosis as defined by the American Thoracic Society criteria
Patients with an FEV1/FVC ratio of less than 80%
Patients with fibrosis on chest x-ray and/or high resolution CT scan.
Patients have had at least two exacerbations of their sarcoidosis in the prior year. An exacerbation is defined as an acute event requiring increase of prednisone with or without use of antibiotics.
Patients must be on a stable dose of corticosteroids and other agents for their sarcoidosis at least 4 weeks prior to first visit.
For patients on prednisone alone, the dose has to be the equivalent of 5 mg prednisone a day. For those on other immunosuppressants, they can be on any dose of prednisone.
Patients must be between ages of 18 and 70 years of age.
Willing to take prednisone at increased dosage for exacerbations of their sarcoidosis.
Patients must be able to provide written informed consent to participate in the study.

Patient Q&A Section

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Other questions from users

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Sarcoidosis by sharing your contact details with the study coordinator.