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Phosphodiesterase-4 (PDE-4) Inhibitor

Roflumilast for Sarcoidosis (REFS Trial)

Phase 4
Waitlist Available
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

REFS Trial Summary

Pulmonary sarcoidosis patients with fibrosis often develop recurrent episodes of bronchitis. These can lead to worsening of disease for both the short and long term. Roflumilast has been shown to reduce the number of acute bronchitis episodes in patients with COPD. Drugs similar to Roflumilast have been shown to help sarcoidosis. The current study is to determine if Roflumilast will reduce number of episodes of bronchitis and help fibrotic sarcoidosis.

REFS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reduction in number of episodes of acute exacerbation
Secondary outcome measures
Change in FVC
Changes in quality of life
Other outcome measures
Safety

Side effects data

From 2015 Phase 4 trial • 12 Patients • NCT03073798
8%
Pulmonary Exacerbation
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Participants

REFS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RoflumilastExperimental Treatment1 Intervention
Roflumilast
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Roflumilast
FDA approved

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemOTHER
300 Previous Clinical Trials
2,099,949 Total Patients Enrolled
Albany Medical CollegeOTHER
91 Previous Clinical Trials
11,447 Total Patients Enrolled
3 Trials studying Sarcoidosis
370 Patients Enrolled for Sarcoidosis
University of CincinnatiLead Sponsor
428 Previous Clinical Trials
634,336 Total Patients Enrolled
14 Trials studying Sarcoidosis
3,722 Patients Enrolled for Sarcoidosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS)
Robert P Baughman 2013. "Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01830959.
All > Stronger Than Sarcoidosis > Flu
~4 spots leftby Apr 2025
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