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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
Sponsor:
Collaborators:
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

April 10, 2013
April 12, 2013
December 8, 2015
April 2013
May 2016   (Final data collection date for primary outcome measure)
Reduction in number of episodes of acute exacerbation [ Time Frame: one year ]
Collect number of episodes of exacerbtion in one year
Same as current
Complete list of historical versions of study NCT01830959 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Safety [ Time Frame: one year ]
recard adverse events
Same as current
 
Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS)
Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS)

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.

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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Sarcoidosis
  • Drug: Roflumilast
    Roflumilast
    Other Name: Daliresp
  • Drug: Placebo
    Placebo one a day
  • Experimental: Roflumilast
    Roflumilast
    Intervention: Drug: Roflumilast
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
60
October 2016
May 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01830959
REFS-1
WIRB Pr #: 20130426 ( Other Identifier: WIRB )
Yes
Not Provided
Not Provided
Robert P Baughman, University of Cincinnati
University of Cincinnati
  • The Cleveland Clinic
  • University of Pittsburgh
  • University of Illinois at Chicago
  • Henry Ford Health System
  • Albany Medical College
Study Chair: Robert P Baughman, MD University of Cincinnati
University of Cincinnati
December 2015

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