Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2017-09-27
2020-03-30
Brief Summary
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Detailed Description
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One 267 mg capsules three times a day for two weeks. Two 267 mg capsules three times a day for two weeks Three 267 mg capsules three times a day thereafter Patients will be instructed to take all doses of medication with food. Dosage will be titrated on an individual basis depending on patient tolerance of medication.
Those randomized to placebo will receive the same schedule using placebo tablets.
Block randomization will be done at each site. Liver function tests will be evaluated as listed above. If the patient has an abnormal liver function test, then the dose will be adjusted per the company's protocol for commercial drug.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Pirfenidone
Pirfenidone titrated to three 267 mg tablets three times a day
Pirfenidone
Increasing doses
Placebos
Placebo titrated to three tablets three times a day
Placebos
Increasing doses
Interventions
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Pirfenidone
Increasing doses
Placebos
Increasing doses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pulmonary function testing with a Composite Physiologic Index (CPI) score of greater than 40
* Patient must have evidence of \>20% fibrosis on high resolution cat scan
* Patients must be on a stable prednisone therapy for sarcoidosis for at least two months and no change in other immunosuppressives in the two months prior to entry into study
* Age greater than 18 and less than 90.
* Able to provide written informed consent for participation in the study
Exclusion Criteria
* Patients with liver disease Childs class 3 or 4
* Patients with a left ventricular ejection fraction of less than 40%
* Patients receiving more than 20 mg prednisone daily or its equivalent
* Patients with massive hemoptysis within prior three months. Patients with mycetomas are eligible as long as no massive hemoptysis in prior three months.
* Patients with clinically important co-existing disease which in the opinion of the investigator is likely to affect patient's chance for survival during the course of the study
* Patient who is pregnant, lactating, intending to become pregnant during the study, or child bearing capacity who is not willing to use appropriate birth control methods approved by investigator
18 Years
90 Years
ALL
No
Sponsors
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Royal Brompton & Harefield NHS Foundation Trust
OTHER
University of Cincinnati
OTHER
Responsible Party
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Robert P Baughman
Professor
Principal Investigators
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Robert P Baughman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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University of Cincinnati
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2016-5706
Identifier Type: -
Identifier Source: org_study_id