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

Sarcoidosis Clinical Trial

— REFS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01830959
• Other study ID #: REFS-1
• Secondary ID: WIRB Pr #: 20130
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 10, 2013
• Last updated: December 4, 2015
• Start date: April 2013
• Est. completion date: October 2016

Study information

• Verified date: December 2015
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: October 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoidosis

Intervention

Drug:
• Roflumilast
Roflumilast
• Placebo
Placebo one a day

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (6)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety	recard adverse events	one year	Yes
Primary	Reduction in number of episodes of acute exacerbation	Collect number of episodes of exacerbtion in one year	one year	No
Secondary	Change in FVC	Changes in FVC over time of the study	one year	No
Secondary	Changes in quality of life	Measure QOL using Sarcoidosis health question, fatigue assessment score, SGRQ, SF-36 Leicester cough questionnaire	One year	No