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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Cincinnati
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
ClinicalTrials.gov Identifier:
NCT01830959
First received: April 10, 2013
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Sarcoidosis
Drug: Roflumilast
Drug: Placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Reduction in number of episodes of acute exacerbation [ Time Frame: one year ] [ Designated as safety issue: No ]
    Collect number of episodes of exacerbtion in one year


Secondary Outcome Measures:
  • Change in FVC [ Time Frame: one year ] [ Designated as safety issue: No ]
    Changes in FVC over time of the study

  • Changes in quality of life [ Time Frame: One year ] [ Designated as safety issue: No ]
    Measure QOL using Sarcoidosis health question, fatigue assessment score, SGRQ, SF-36 Leicester cough questionnaire


Other Outcome Measures:
  • Safety [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    recard adverse events


Estimated Enrollment: 60
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Roflumilast
Roflumilast
Drug: Roflumilast
Roflumilast
Other Names:
  • Roflumilast
  • Daliresp
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo one a day
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01830959

Contacts
Contact: Robert P Baughman, MD 513-584-5225 bob.baughman@uc.edu
Contact: Rebecca Ingledue 513-584-6252

Locations
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Robert P Baughman, MD    513-584-5225    bob.baughman@uc.edu   
Contact: Rebecca Ingledue    513-584-6252      
Principal Investigator: Robert P Baughman, MD         
Sponsors and Collaborators
University of Cincinnati
The Cleveland Clinic
University of Pittsburgh
University of Illinois at Chicago
Henry Ford Health System
Albany Medical College
Investigators
Study Chair: Robert P Baughman, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: Robert P Baughman, Professor of Medicine, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01830959     History of Changes
Other Study ID Numbers: REFS-1, WIRB Pr #: 20130426
Study First Received: April 10, 2013
Last Updated: April 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Sarcoidosis, fibrosis, bronchiectasis

Additional relevant MeSH terms:
Sarcoidosis
Lymphatic Diseases
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on November 20, 2014