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

Sarcoidosis Clinical Trial

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

Clinical 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.

Clinical Trial Description

This will be a multicenter, double blind, placebo controlled study. Patients would be randomized 1:1 to receive either roflumilast 500 mcg per day or placebo added to their current treatment regimen for twelve months. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01830959
Study type Interventional
Source University of Cincinnati
Contact
Status Active, not recruiting
Phase Phase 4
Start date April 2013
Completion date October 2016
View Details
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