The INSPIRE Trial: A Study of Interferon Gamma-1b for Idiopathic Pulmonary Fibrosis (IPF)

Exclusion Criteria

• •1. Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study, in the opinion of the Principal Investigator (PI)
• •2. Forced expiratory volume in the first second (FEV1)/FVC ratio \< 0.6 (after administration of bronchodilator)
• •3. Residual volume (RV) \> 140% of predicted (before administration of bronchodilator)
• •4. History of clinically significant environmental exposure known to cause pulmonary fibrosis (including but not limited to drugs, asbestos, beryllium, radiation, domestic birds)
• •5. Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, and cancer
• •6. Diagnosis of any connective tissue disease, including but not limited to scleroderma, systemic lupus erythematosus, and rheumatoid arthritis
• •7. Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis, urinary tract infection, and cellulitis
• •8. On a lung transplantation waiting list at time of randomization
• •Medical Exclusions:
• •9. Any history of malignancy likely to result in death, significant disability, or likely to require significant medical or surgical intervention within the next 3 years. This does not include minor surgical procedures for localized carcinoma (e.g., basal cell carcinoma)
• •10. Any condition other than IPF which, in the opinion of the PI, is likely to result in the death of the patient within the next 3 years
• •11. History of unstable or deteriorating cardiac, vascular, or neurologic disease within the previous 6 months, including but not limited to the following:
• •* Myocardial infarction, unstable angina pectoris, coronary artery bypass surgery, or coronary angioplasty
• •* Congestive heart failure requiring hospitalization
• •* Uncontrolled arrhythmias
• •* Thromboembolic event (e.g., deep vein thrombosis, pulmonary embolism)
• •* Transient ischemic attacks (TIAs) or cerebral vascular accident
• •12. Any condition, which, in the opinion of the investigator, might be significantly exacerbated by the known side effects, (e.g., flu-like syndrome) associated with the administration of IFN g 1b
• •13. History of any of the following medical conditions:
• •* Multiple sclerosis
• •* Seizures within the past 10 years or taking anti seizure medication
• •* Severe or poorly controlled diabetes
• •14. Pregnancy or lactation. Females of childbearing potential are required to have a negative serum pregnancy test before treatment and must agree to practice abstinence or prevent pregnancy by at least a barrier method of birth control for the duration of the study
• •15. Inability to tolerate nonsteroidal anti-inflammatory drugs (NSAIDS) or acetaminophen (paracetamol)
• •16. History of ethanol abuse in the past 2 years
• •17. Known hypersensitivity to IFN-g or closely related interferons or to any component of the study treatment
• •18. Presence of human immunodeficiency virus (HIV) or chronic viral hepatitis
• •Laboratory Exclusions:
• •19. Any of the following liver function test criteria above specified limits:
• •Total bilirubin \> 1.5 x upper limit of normal (ULN); aspartate or alanine aminotransferases (AST/SGOT or ALT/SGPT) \> 2 x ULN; alkaline phosphatase \> 2 x ULN; or albumin \< 3.0 mg/dL
• •20. Any of the following hematology test criteria outside of specified limits: WBC \< 2,500/mm3, hematocrit \< 30% or \> 59%, platelets \< 100,000 /mm3
• •21. Creatinine \> 1.5 x ULN
• •Concomitant Therapy Exclusions:
• •22. Prednisone therapy (prednisone or equivalent, with dose adjusted for potency) in excess of 0.125 mg/kg ideal body weight (IBW) per day or in excess of 0.25 mg/kg IBW every other day. Patients will also be excluded if they were not on a stable dose of corticosteroid therapy for at least 28 days prior to screening.
• •23. Prior treatment with IFN g 1b
• •24. Investigational therapy (i.e., agents that are not approved by local regulatory agencies) for any indication within 28 days prior to screening
• •25. The following therapies are excluded within 28 days prior to screening:
• •* Investigational therapy for IPF, including pirfenidone
• •* Any cytotoxic/immunosuppressive agent other than corticosteroids (including but not limited to azathioprine, cyclophosphamide, methotrexate, cyclosporine)
• •* Any cytokine modulators (including but not limited to etanercept, infliximab)
• •* Any therapy targeted to treat IPF (including but not limited to d penicillamine, colchicine, bosentan, N-acetyl-cysteine \[NAC\])