Study comparing pirfenidone versus placebo for patients with advanced fibrotic sarcoidosis
Patients who meet the inclusion and exclusion criteria will be randomized to be treated with either placebo or pirfenidone at the current approved dosage for idiopathic pulmonary fibrosis at a 2:1 pirfenidone to placebo ratio. Patients treated with pirfenidone will be titrated using the following schedule: 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Increasing doses
Increasing doses
University of Cincinnati
Cincinnati, Ohio, United States
RECRUITINGTime until clinical worsening (TCW)
TCW
Time frame: two years
Change in forced vital capacity (FVC)
Change in forced vital capacity
Time frame: two years
Change in CPI
Change in composite physiologic index
Time frame: two years
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