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

Primary Purpose

Sarcoidosis

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Roflumilast

Placebo

About this trial

This is an interventional treatment trial for Sarcoidosis focused on measuring Sarcoidosis, fibrosis, bronchiectasis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with sarcoidosis as defined by the American Thoracic Society criteria
Patients with an FEV1/FVC ratio of less than 80%
Patients with fibrosis on chest x-ray and/or high resolution CT scan.
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.
Patients must be on a stable dose of corticosteroids and other agents for their sarcoidosis at least 4 weeks prior to first visit.
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.
Patients must be between ages of 18 and 70 years of age.
Willing to take prednisone at increased dosage for exacerbations of their sarcoidosis.
Patients must be able to provide written informed consent to participate in the study.

Exclusion Criteria:

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.
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.
Patients with serum creatinine of greater than 3 mg/dL
Patients with moderate or severe liver disease as defined Child Pugh class 3 or 4.
Patients with unstable cardiac disease
Patients with non cutaneous malignancy treated in the past two years.
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.

Sites / Locations

University of Cincinnati

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Roflumilast

Placebo

Arm Description

Roflumilast

Placebo

Outcomes

Primary Outcome Measures

Reduction in number of episodes of acute exacerbation

Collect number of episodes of exacerbtion in one year

Secondary Outcome Measures

Change in FVC

Changes in FVC over time of the study

Changes in quality of life

Measure QOL using Sarcoidosis health question, fatigue assessment score, SGRQ, SF-36 Leicester cough questionnaire

Full Information

NCT ID

NCT01830959

First Posted

April 10, 2013

Last Updated

December 4, 2015

Sponsor

University of Cincinnati

Collaborators

The Cleveland Clinic, University of Pittsburgh, University of Illinois at Chicago, Henry Ford Health System, Albany Medical College

1. Study Identification

Unique Protocol Identification Number

NCT01830959

Brief Title

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

Acronym

REFS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Unknown status

Study Start Date

April 2013 (undefined)

Primary Completion Date

May 2016 (Anticipated)

Study Completion Date

October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Cincinnati

Collaborators

The Cleveland Clinic, University of Pittsburgh, University of Illinois at Chicago, Henry Ford Health System, Albany Medical College

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoidosis

Keywords

Sarcoidosis, fibrosis, bronchiectasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Roflumilast

Arm Type

Experimental

Arm Description

Roflumilast

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Roflumilast

Other Intervention Name(s)

Daliresp

Intervention Description

Roflumilast

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo one a day

Primary Outcome Measure Information:

Title

Reduction in number of episodes of acute exacerbation

Description

Collect number of episodes of exacerbtion in one year

Time Frame

one year

Secondary Outcome Measure Information:

Title

Change in FVC

Description

Changes in FVC over time of the study

Time Frame

one year

Title

Changes in quality of life

Description

Measure QOL using Sarcoidosis health question, fatigue assessment score, SGRQ, SF-36 Leicester cough questionnaire

Time Frame

One year

Other Pre-specified Outcome Measures:

Title

Safety

Description

recard adverse events

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with sarcoidosis as defined by the American Thoracic Society criteria Patients with an FEV1/FVC ratio of less than 80% Patients with fibrosis on chest x-ray and/or high resolution CT scan. 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. Patients must be on a stable dose of corticosteroids and other agents for their sarcoidosis at least 4 weeks prior to first visit. 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. Patients must be between ages of 18 and 70 years of age. Willing to take prednisone at increased dosage for exacerbations of their sarcoidosis. Patients must be able to provide written informed consent to participate in the study. Exclusion Criteria: 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. 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. Patients with serum creatinine of greater than 3 mg/dL Patients with moderate or severe liver disease as defined Child Pugh class 3 or 4. Patients with unstable cardiac disease Patients with non cutaneous malignancy treated in the past two years. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert P Baughman, MD

Organizational Affiliation

University of Cincinnati

Official's Role

Study Chair

Facility Information:

Facility Name

University of Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

34744427

Citation

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.

Results Reference

derived

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

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