NCT01830959

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

December 8, 2015

Status Verified

December 1, 2015

Enrollment Period

3.1 years

First QC Date

April 10, 2013

Last Update Submit

December 4, 2015

Conditions

Sarcoidosis

Keywords

Sarcoidosis, fibrosis, bronchiectasis

Outcome Measures

Primary Outcomes (1)

  • Reduction in number of episodes of acute exacerbation

    Collect number of episodes of exacerbtion in one year

    one year

Secondary Outcomes (2)

  • Change in FVC

    one year

  • Changes in quality of life

    One year

Other Outcomes (1)

  • Safety

    one year

Study Arms (2)

Roflumilast

EXPERIMENTAL

Roflumilast

Drug: Roflumilast

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

RoflumilastDRUG

Roflumilast

Also known as: Daliresp
Roflumilast
PlaceboDRUG

Placebo one a day

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Related Publications (1)

  • 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.

    PMID: 34744427DERIVED

MeSH Terms

Conditions

SarcoidosisFibrosisBronchiectasis

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory Tract Diseases

Study Officials

  • Robert P Baughman, MD

    University of Cincinnati

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

April 10, 2013

First Posted

April 12, 2013

Study Start

April 1, 2013

Primary Completion

May 1, 2016

Study Completion

October 1, 2016

Last Updated

December 8, 2015

Record last verified: 2015-12

Locations

US(1)