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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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.


Detailed Summary: 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.
Sponsor: University of Cincinnati

Current Primary Outcome: Reduction in number of episodes of acute exacerbation [ Time Frame: one year ]

Collect number of episodes of exacerbtion in one year


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in FVC [ Time Frame: one year ]
    Changes in FVC over time of the study
  • Changes in quality of life [ Time Frame: One year ]
    Measure QOL using Sarcoidosis health question, fatigue assessment score, SGRQ, SF-36 Leicester cough questionnaire


Original Secondary Outcome: Same as current

Information By: University of Cincinnati

Dates:
Date Received: April 10, 2013
Date Started: April 2013
Date Completion: October 2016
Last Updated: December 4, 2015
Last Verified: December 2015