Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | April 2013 |
| End Date: | October 2016 |
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.
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.
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.
randomized 1:1 to receive either roflumilast 500 mcg per day or placebo added to their
current treatment regimen for twelve months.
Inclusion Criteria:
1. Patients with sarcoidosis as defined by the American Thoracic Society criteria
2. Patients with an FEV1/FVC ratio of less than 80%
3. Patients with fibrosis on chest x-ray and/or high resolution CT scan.
4. 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.
5. Patients must be on a stable dose of corticosteroids and other agents for their
sarcoidosis at least 4 weeks prior to first visit.
6. 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.
7. Patients must be between ages of 18 and 70 years of age.
8. Willing to take prednisone at increased dosage for exacerbations of their
sarcoidosis.
9. Patients must be able to provide written informed consent to participate in the
study.
Exclusion Criteria:
1. 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.
2. 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.
3. Patients with serum creatinine of greater than 3 mg/dL
4. Patients with moderate or severe liver disease as defined Child Pugh class 3 or 4.
5. Patients with unstable cardiac disease
6. Patients with non cutaneous malignancy treated in the past two years.
7. 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.
We found this trial at
1
site
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
Click here to add this to my saved trials
