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
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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
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients with sarcoidosis as defined by the American Thoracic Society criteria
- Patients with an FEV1/FVC ratio of less than 80%
- Patients with fibrosis on chest x-ray and/or high resolution CT scan.
- Patients have had at least two exacerbations of their sarcoidosis in the prior year. An exacerbation is defined as an acute event requiring increase of prednisone with or without use of antibiotics.
- Patients must be on a stable dose of corticosteroids and other agents for their sarcoidosis at least 4 weeks prior to first visit.
- For patients on prednisone alone, the dose has to be the equivalent of 5 mg prednisone a day. For those on other immunosuppressants, they can be on any dose of prednisone.
- Patients must be between ages of 18 and 70 years of age.
- Willing to take prednisone at increased dosage for exacerbations of their sarcoidosis.
- Patients must be able to provide written informed consent to participate in the study.
- Patients with known hypersensitivity to theophylline or pentoxifylline will not be eligible. Patients with dose dependent nausea from these drugs may still participate in the trial.
- Patients will not be able to take theophylline or pentoxifylline during the time of the study. They will be allowed to take drugs for sarcoidosis including prednisone, methotrexate, azathioprine, leflunomide, hydroxychloroquine, thalidomide, infliximab, adalimumab, and rituximab.
- Patients with serum creatinine of greater than 3 mg/dL
- Patients with moderate or severe liver disease as defined Child Pugh class 3 or 4.
- Patients with unstable cardiac disease
- Patients with non cutaneous malignancy treated in the past two years.
- Patients unable to complete the questionnaires and six minute walks detailed in the study.Women of child bearing potential unable to use adequate birth control as determined by the investigator.
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|
|Responsible Party:||Robert P Baughman, Professor of Medicine, University of Cincinnati|
|Other Study ID Numbers:||
WIRB Pr #: 20130426 ( Other Identifier: WIRB )
|First Posted:||April 12, 2013 Key Record Dates|
|Last Update Posted:||December 8, 2015|
|Last Verified:||December 2015|
Sarcoidosis, fibrosis, bronchiectasis