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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 December 2015
• Main ID: NCT01830959
• Date of registration: 10/04/2013
• Prospective Registration: No
• Primary sponsor: University of Cincinnati
• Public title: Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS) REFS
• Scientific title: Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS)
• Date of first enrolment: April 2013
• Target sample size: 50
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT01830959
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Robert P Baughman, MD
• Affiliation: University of Cincinnati

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Sarcoidosis

Intervention(s)

Drug: Placebo

Drug: Roflumilast

Primary Outcome(s)

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

Secondary Outcome(s)

Change in FVC [Time Frame: one year]

Changes in quality of life [Time Frame: One year]

Secondary ID(s)

REFS-1

WIRB Pr #: 20130426

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Albany Medical College

University of Pittsburgh

Henry Ford Health System

The Cleveland Clinic

University of Illinois at Chicago