Targeting Pro-Inflammatory Cells in Idiopathic Pulmonary Fibrosis: a Human Trial

Exclusion Criteria

• •1. More than two moderate/severe IPF exacerbations within the past year Exacerbation is defined as worsening of two or more of the following major symptoms: dyspnea, sputum volume, sputum purulence OR worsening of any one major symptom together with at least one of the following additional symptoms: sore throat, colds (nasal discharge and/or nasal congestion), fever \> 37.5 ° C without any explained cause, increased cough, increase wheeze.
• •A moderate exacerbation is defined as an event that is associated with a new prescription for antibiotics and/or oral steroids. A severe exacerbation is defined as an event that is associated with hospitalization or emergency room visit.
• •2. Any moderate/severe IPF exacerbation within the past 4 weeks.
• •3. History of a lung transplant.
• •4. Use of anti-arrhythmic medications known to cause QTc prolongation.
• •5. Pulmonary hypertension or cor pulmonale confirmed by echocardiography or heart catheterization.
• •6. Myocardial infarction, angina, hospitalization for cardiac aetiology, stroke or transient ischemic attack in the past 6 months.
• •7. Chronic heart failure.
• •8. Neurologic, musculoskeletal, or other condition that in the opinion of the study physician limits subject's ability to complete study physical assessments.
• •9. Uncontrolled diabetes (HbA1c \> 8% and fasting glucose \>200 mg/dL or the current use of insulin).
• •10. Subjects with values outside the specified ranges for the following Key Clinical Laboratory Tests must be excluded from the study:
• •Renal function: Glomerular Filtration Rate (GFR) \<30 (mL/min/1.73 m2) using formulae provided in the Study Reference Manual (SRM). Note: Subjects receiving dialysis are excluded from this study.
• •ALT \>2xULN and bilirubin \>1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
• •11. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• •12. QTcB or QTcF \> 450 msec or QTc \> 480 msec in subjects with Bundle Branch Block based on a single ECG.
• •13. Subjects with a history of malignancy that is not in complete remission for at least 2 years or 1 year for non-melanoma skin carcinoma.
• •14. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to participation in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
• •15. History of drug or alcohol abuse within 5 years prior to randomization.
• •16. Use of Coumadin or other anti-platelet or anti-coagulant medication. The use of aspirin is permitted.
• •17. Current use of quinolone antibiotics.
• •18. Low CBC.
• •19. Cognitive Impairment (MoCA score less than 21)
• •20. Other medical or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention