A study to compare the efficacy and safety of pirfenidone in patients with progressive pulmonary fibrosis

Not Applicable

Conditions: Diseases of the respiratory system

Registration Number: KCT0009628

Lead Sponsor: Asan Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 102

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

1) Screening visit criteria, FEV1/FVC <0.7 after administration of bronchodilators
2) ILD patients with radiation, sarcoidosis, pneumothoraxic hearing loss pneumonia, HIV, viral hepatitis, and cancer
3) Persons with active infections including, but not limited to, bronchitis, pneumonia, sinusitis, urinary tract infection or cellulitis
4) Those who need a lung transplant within the clinical trial period after randomization, as judged by the clinical research director and the person in charge
5) Those who cannot undergo a pulmonary function test
6) Those who are likely to die or cause serious disability or have a history of malignancy within the past 5 years (skin* or cervical cancer within 2 years)
*Localized cancer (e.g., basal cell carcinoma)
7) Those with a history of advanced cirrhosis or clinically significant liver disease, such as patients with severe liver disorder or end-stage epilepsy
8) Those with a history of unstable heart or lung disease (excluding IPF) within the last 6 months, including, but not limited to, myocardial infarction, unstable angina, coronary bypass, coronary angioplasty or uncontrolled arrhythmia requiring hospitalization, as follows
A. Myocardial infarction, unstable angina, coronary bypass or coronary angioplasty
B. Congestion heart failure requiring hospitalization
C. Uncontrolled arrhythmia
D. Asthma or chronic bronchitis requiring hospitalization within the last 6 months
E. Acute exacerbation
9) Those who are contraindicated (who have hypersensitivity to the ingredients of clinical trial drugs) according to Piresco's permission
10) Pregnant women or nursing mothers
11) A person who has a history of alcohol or substance abuse in the past two years as of screening visits
12) A person who has a history of conditions or habits related to consciousness change and aspiration risk over the past two years as of screening visits
13) A person who has a family history or personal history of Long QT syndrome
14) Those treated with one of the following drugs: Fluvoxamine (any time), all research drugs within the last 6 months, specific interventional drugs that start more than 6 months ago and do not maintain stable pH thereafter and throughout the study period.
15) Those with severe pulmonary hypertension (PULMONARY VASCULAR RESISTANCE, PVR > 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