Use of Roflumilast to Prevent Exacerbations in Fibrotic S... | NCT01830959

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

NCT01830959

Sponsor

University of Cincinnati

Status

Unknown status

Last Update Posted

Dec 8, 2015Estimated

Enrollment

50Estimated

Phase

Phase 4

Conditions

Sarcoidosis

Interventions

Roflumilast
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
WIRB Pr #: 20130426	Other Identifier	WIRB

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

May 2016Estimated

Completion Date

Oct 2016Estimated

First Submitted Date

Apr 10, 2013

First Submission Date that Met QC Criteria

Apr 10, 2013

First Posted Date

Apr 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2015

Last Update Posted Date

Dec 8, 2015Estimated

Name	Class
The Cleveland Clinic	OTHER
University of Pittsburgh	OTHER
University of Illinois at Chicago	OTHER
Henry Ford Health System

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Label	Type	Description	Intervention Names
Roflumilast	Experimental	Roflumilast	Drug: Roflumilast
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Roflumilast	Drug	Roflumilast	Roflumilast	Daliresp

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in number of episodes of acute exacerbation	Collect number of episodes of exacerbtion in one year	one year

Secondary Outcomes

Measure	Description	Time Frame
Change in FVC	Changes in FVC over time of the study	one year
Changes in quality of life	Measure QOL using Sarcoidosis health question, fatigue assessment score, SGRQ, SF-36 Leicester cough questionnaire

Other Outcomes

Measure	Description	Time Frame
Safety	recard adverse events	one year

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Robert P Baughman, MD	University of Cincinnati	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
University of Cincinnati		Cincinnati	Ohio	45267	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34744427	Derived	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.

ID	Term
D012507	Sarcoidosis
D005355	Fibrosis
D001987	Bronchiectasis

ID	Term
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D006968	Hypersensitivity, Delayed