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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
University of Cincinnati
Study ID
NCT01830959
Phase
PHASE4
Status
Unknown

Conditions

  • Sarcoidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    Roflumilast
  • Placebo — DRUG
    Placebo one a day

Study Details

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.

Key Dates

Start date
Apr 30, 2013
Status verified
Dec 2015
Primary completion
May 31, 2016
Completion
Oct 31, 2016

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Roflumilast
    Roflumilast
  • Placebo Comparator: Placebo
    Placebo

Primary Outcome Measure

Reduction in number of episodes of acute exacerbation [ Time Frame: one year ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of CincinnatiCincinnatiOhio45267-

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By research site
University of Cincinnati· Cincinnati, OH

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