Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS) (REFS)
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|ClinicalTrials.gov Identifier: NCT01830959|
Recruitment Status : Unknown
Verified December 2015 by Robert P Baughman, University of Cincinnati.
Recruitment status was: Active, not recruiting
First Posted : April 12, 2013
Last Update Posted : December 8, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoidosis||Drug: Roflumilast Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS)|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||October 2016|
Other Name: Daliresp
Placebo Comparator: Placebo
Placebo one a day
- Reduction in number of episodes of acute exacerbation [ Time Frame: one year ]Collect number of episodes of exacerbtion in one year
- 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
- Safety [ Time Frame: one year ]recard adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830959
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267|
|Study Chair:||Robert P Baughman, MD||University of Cincinnati|