Clinical trial: Open-label Study to Assess the Effectiveness of Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis (IPF). (NCT03208933)

Eligibility criteria:
Inclusion Criteria:

          -  Clinical symptoms consistent with IPF of ≥ 6months duration

          -  Participants could have both "confident" or "consistent" with UIP diagnosis of IPF
             based on clinical, radiologic and pathologic data according to 2011 American Thoracic
             Society/European Respiratory Society (ATS/ERS) guidelines at the Screening. HRCT scan
             performed within 24 months before the start of the Screening may be used, if it meets
             all image acquisition guideline

          -  No features supporting an alternative diagnosis on transbronchial biopsy,
             bronchoalveolar lavage (BAL), or surgical lung biopsy, if performed. Results of the
             surgical lung biopsy performed within the last 4 years must be confirmed by central
             review

          -  Participants with %FVC ≥ 40 % at the Screening

          -  Participants with %Carbon monoxide diffusing capacity (DLCO) ≥ 30 % at the Screening

          -  Ability to walk ≥ 100 m during the 6-minute walk test at the Screening

          -  Eligible participants must discontinue all prohibited medications at least 28 days
             before the Screening

          -  Female participants of childbearing potential must have negative urine pregnancy test
             at the Screening and before first dosing on Day 1

        Exclusion Criteria:

          -  Significant clinical worsening of IPF between Screening and Day 1, in the opinion of
             the investigator

          -  Relevant airways obstruction (i.e. pre-bronchodilator forced expiratory volume
             (FEV)1/FVC < 0.7)

          -  Cigarette smoking within 28 days before the start of treatment or unwilling to avoid
             tobacco products throughout the study

          -  History of clinically significant environmental exposure known to cause pulmonary
             fibrosis (PF), including but not limited to drugs (such as amiodarone), asbestos,
             beryllium, radiation, and domestic birds

          -  Known explanation for interstitial lung disease, including but not limited to
             radiation, drug toxicity, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis
             obliterans organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis,
             and cancer

          -  Clinical diagnosis of any connective tissue disease, including but not limited to
             scleroderma, polymyositis/ dermatomyositis, systemic lupus erythematosus, and
             rheumatoid arthritis

          -  During baseline analysis of HRCT, significant coexistent emphysema (emphysema extent
             greater than extent of fibrosis) confirmed by central review

          -  Planned lung transplantation during the study

          -  Clinical evidence of active infection, including but not limited to bronchitis,
             pneumonia, sinusitis, urinary tract infection, or cellulitis

          -  Unable to perform 6MWT or to undergo pulmonary function test

          -  Any history of malignancy likely to result in significant disability or likely to
             require significant medical or surgical intervention within the next 1 years. This
             does not include minor surgical procedures for localized cancer (e.g., basal cell
             carcinoma)

          -  History of severe hepatic impairment or end-stage liver disease

          -  History of end-stage renal disease requiring dialysis

          -  History of unstable or deteriorating cardiac or pulmonary disease (other than IPF)
             within the previous 6 months

          -  Pregnancy or lactation, or intention to become pregnant during the study. Women of
             childbearing capacity are required to have a negative urine pregnancy test before
             treatment and must agree to maintain highly effective contraception

          -  Liver function test outside specified limits at the Screening: total bilirubin above
             the upper limit of normal (ULN); aspartate or alanine aminotransferase (AST or ALT) >
             3 × ULN; alkaline phosphatase > 2.5 × ULN

          -  Creatinine clearance < 30 mL/min, calculated using the Cockcroft-Gault formula

          -  Electrocardiogram (ECG) with a QT interval corrected according to Fridericia's formula
             (QTcF) > 500 msec at the Screening
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea.  Other medical conditions include hypertension and osteoarthritis.  The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs.  He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs.  Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled  pulmonary fibrosis that is most predominant in the lower lobes, characterized  by the presence of asbestos bodies (golden-brown beaded rods with translucent centers).

Patient description (patient's own words): I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there.

Does the patient match the trial criteria? 1