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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
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

Tracking Information
First Submitted Date  ICMJE April 10, 2013
First Posted Date  ICMJE April 12, 2013
Last Update Posted Date December 8, 2015
Study Start Date  ICMJE April 2013
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2013)
Reduction in number of episodes of acute exacerbation [ Time Frame: one year ]
Collect number of episodes of exacerbtion in one year
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 10, 2013)
Safety [ Time Frame: one year ]
recard adverse events
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS)
Official Title  ICMJE Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS)
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sarcoidosis
Intervention  ICMJE
  • Drug: Roflumilast
    Other Name: Daliresp
  • Drug: Placebo
    Placebo one a day
Study Arms  ICMJE
  • Experimental: Roflumilast
    Intervention: Drug: Roflumilast
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Baughman RP, Judson MA, Culver DA, Birring SS, Parambil J, Zeigler J, Lower EE. Roflumilast (Daliresp(R)) to reduce acute pulmonary events in fibrotic sarcoidosis: a multi-center, double blind, placebo controlled, randomized clinical trial. Sarcoidosis Vasc Diffuse Lung Dis. 2021;38(3):e2021035. doi: 10.36141/svdld.v38i3.11684. Epub 2021 Sep 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 4, 2015)
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2013)
Estimated Study Completion Date  ICMJE October 2016
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01830959
Other Study ID Numbers  ICMJE REFS-1
WIRB Pr #: 20130426 ( Other Identifier: WIRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Robert P Baughman, University of Cincinnati
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Cincinnati
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • The Cleveland Clinic
  • University of Pittsburgh
  • University of Illinois at Chicago
  • Henry Ford Health System
  • Albany Medical College
Investigators  ICMJE
Study Chair: Robert P Baughman, MD University of Cincinnati
PRS Account University of Cincinnati
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP