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

NCT01830959 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-12-08

No results posted yet for this study

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.

Conditions

  • Sarcoidosis

Interventions

DRUG

Roflumilast

Roflumilast

DRUG

Placebo

Placebo one a day

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • University of Pittsburgh

    collaborator OTHER

  • University of Illinois at Chicago

    collaborator OTHER

  • Henry Ford Health System

    collaborator OTHER

  • Albany Medical College

    collaborator OTHER

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Robert P Baughman, MD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-05-31
Completion
2016-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01830959 on ClinicalTrials.gov