Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS)|
- Reduction in number of episodes of acute exacerbation [ Time Frame: one year ] [ Designated as safety issue: No ]Collect number of episodes of exacerbtion in one year
- Change in FVC [ Time Frame: one year ] [ Designated as safety issue: No ]Changes in FVC over time of the study
- Changes in quality of life [ Time Frame: One year ] [ Designated as safety issue: No ]Measure QOL using Sarcoidosis health question, fatigue assessment score, SGRQ, SF-36 Leicester cough questionnaire
- Safety [ Time Frame: one year ] [ Designated as safety issue: Yes ]recard adverse events
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Placebo one a day
Other Name: Placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01830959
|Contact: Robert P Baughman, MDfirstname.lastname@example.org|
|Contact: Rebecca Ingledue||513-584-6252|
|United States, Ohio|
|University of Cincinnati||Recruiting|
|Cincinnati, Ohio, United States, 45267|
|Contact: Robert P Baughman, MD 513-584-5225 email@example.com|
|Contact: Rebecca Ingledue 513-584-6252|
|Principal Investigator: Robert P Baughman, MD|
|Study Chair:||Robert P Baughman, MD||University of Cincinnati|