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

• ClinicalTrials.gov Identifier: NCT01830959
• Recruitment Status: Unknown
• First Posted: April 12, 2013
• Last Update Posted: December 8, 2015
• Sponsor: University of Cincinnati
• 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

Study Description

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.

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Roflumilast; Roflumilast	Drug: Roflumilast; Roflumilast; Other Name: Daliresp
Placebo Comparator: Placebo; Placebo	Drug: Placebo; Placebo one a day

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

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

Investigators

• Study Chair: Robert P Baughman, MD; University of Cincinnati

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• 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:

Sarcoidosis; Lymphoproliferative Disorders; Lymphatic Diseases