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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
The Cleveland Clinic
University of Pittsburgh
University of Illinois at Chicago
Henry Ford Health System
Albany Medical College
Information provided by (Responsible Party):
Robert P Baughman, University of Cincinnati

Brief Summary:

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

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis
Drug Information available for: Roflumilast

Arm Intervention/treatment
Experimental: Roflumilast
Drug: Roflumilast
Other Name: Daliresp

Placebo Comparator: Placebo
Drug: Placebo
Placebo one a day

Primary Outcome Measures :
  1. Reduction in number of episodes of acute exacerbation [ Time Frame: one year ]
    Collect number of episodes of exacerbtion in one year

Secondary Outcome Measures :
  1. Change in FVC [ Time Frame: one year ]
    Changes in FVC over time of the study

  2. Changes in quality of life [ Time Frame: One year ]
    Measure QOL using Sarcoidosis health question, fatigue assessment score, SGRQ, SF-36 Leicester cough questionnaire

Other Outcome Measures:
  1. Safety [ Time Frame: one year ]
    recard adverse events

Information from the National Library of Medicine

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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

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.

Information from the National Library of Medicine

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

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United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
The Cleveland Clinic
University of Pittsburgh
University of Illinois at Chicago
Henry Ford Health System
Albany Medical College
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Study Chair: Robert P Baughman, MD University of Cincinnati
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robert P Baughman, Professor of Medicine, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01830959    
Other Study ID Numbers: REFS-1
WIRB Pr #: 20130426 ( Other Identifier: WIRB )
First Posted: April 12, 2013    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015
Keywords provided by Robert P Baughman, University of Cincinnati:
Sarcoidosis, fibrosis, bronchiectasis
Additional relevant MeSH terms:
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Lymphoproliferative Disorders
Lymphatic Diseases