None listed
Conditions
Interventions
Drug : Drug name: Piresco tablet 200mg, 400mg, 600mg
Usage, dosage and administration method: Randomly assigned test subjects administer a test drug or placebo three times a day, one tablet once a day
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Those aged 19 or older at the time of screening 2) At the time of screening, the clinical research director and the person in charge will be in line with the PPF definition* *In the International Society of Respiratory Diseases' Clinical Practice Guidelines (2022 ATS/ERS/JRS/ALAT clinical practice guideline), PPF is defined as a case that satisfies at least two of the following three criteria (deterioration of respiratory symptoms; physiological evidence of disease progression; radiological evidence of disease progression) in the past year among ILD patients with radiological evidence of pulmonary fibrosis. 1) aggravation of respiratory symptoms 2) Physiological evidence of disease progression: Those with an absolute value of FVC reduction during a 1-year follow-up of = 5% or those with an absolute value of a reduction in hemoglobin value (Dlco) during a 1-year follow-up of = 10% predicted 3) Imaging evidence (one or more of the following, blindfolded evaluators): a. Tract bronchial/bronchial dilatation (Trace bronchial/bronchioelectasis) range, deterioration b. New ground glass opacity and traction bronchial dilatation c. New micro-network (Reticulation) d. Degradation of the degree and category of reticular abnormality e. Newly discovered honeycombing or deterioration of existing honeycomb shapes f. Deterioration of Lobar volume loss of lung lobe 3) High-resolution computed tomography (HRCT) at screening shows a degree of fibrosis of 10% or more 4) FVC 45% predicted or higher at screening time 5) Dlco 30% predicated or higher at screening time 6) 6 minute walk distance (6MWD) at the time of screening. Those with a distance of 150m or higher 7) A person who has voluntarily agreed in writing to participate in this clinical trial
Exclusion criteria
Exclusion criteria: 1) Screening visit criteria, FEV1/FVC 900 dynes/sec/cm-5) 16) Current smokers 17) Subjects who meet the criteria above the specified limits in the liver function test* according to the institution-specific criteria during clinical laboratory examination *Total bilirubin > 2.5 Upper Limit of Normal (ULN), AST/SGOT or ALT/SGPT > 2.5 ULN; alkaline phosphatase > 2.5 ULN, eGFR <30 ml/min. 18) Those who have previously used Piresco tablets have applied 15 mg or more of prednisolone equivalent per day, or have used conventional steroid or immunosuppressant therapy within the past 3 months if they are less than 15 mg (excluding conventional steroids and immunosuppressant stable dose users) *: Methylprednisolone, Prednisolone , : Azathioprine, cyclophosphamide, cyclosporin, mycophenolate mofetil 19) A person who has a history of angioplasmic edema associated with the use of a previous pyresco tablet 20) A person who performs combination therapy with a drug that simultaneously inhibits CYP1A2, CYP2C9, CYP2c19, CYP2D6, and CYP2E18 21) Those undergoing combination therapy (full list of CYP drug interactions) with potent inhibitors or inducers of CYP1A28 22) A person who is not appropriate to part
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in FVC (mL) at 12 and 24 weeks after administration of pyresco tablet compared to placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| • Changes in FVC (% predicted) at 12 weeks and 24 weeks after administration of Pirescovine compared to placebo • Changes in the proportion of subjects by group (based on FVC = 5% and FVC = 10%) at 12 weeks and 24 weeks after administration of Pirescovine compared to placebo • Changes in Dlco (% predicted) at 12 weeks and 24 weeks after administration of Pirescovine compared to placebo • Changes in 6MWD at 12 weeks and 24 weeks after administration of Pirescovine compared to placebo • Changes in quality of life evaluation (EQ-5D, K-BILD, L-PF) scores at 12 weeks and 24 weeks after administration of Pirescovine compared to placebo • Changes in FCV (mL) by group (death, acute exacerbation, hospitalization (whole, respiratory system member) at 12 weeks and 24 weeks after administration of Pirescovine compared to placebo • Changes in FCV (mL) by group (total, respiratory system member) at 12 weeks and 24 weeks after administration of Pirescovine compared to placebo | — |
Countries
Korea, Republic of
Contacts
Public ContactJunyoung Kim
Asan Medical Center
Outcome results
None listed