Evaluating the Effectiveness of Prednisone, Azathioprine, and N-acetylcysteine in Patients With IPF

Exclusion Criteria

• •History of clinically significant environmental exposure known to cause pulmonary fibrosis
• •Diagnosis of connective tissue disease as the likely cause of the interstitial disease
• •Extent of emphysema greater than the extent of fibrotic change (i.e., honeycombing, reticular changes) on high resolution computed tomography (HRCT) scan
• •Forced expiratory volume in 1 second (FEV1)/FVC ratio less than 0.65 at the time of screening (post-bronchodilator)
• •Partial pressure of arterial oxygen (PaO2) less than 55 mm Hg (less than 50 mm Hg at Denver study site)
• •Residual volume greater than 120% predicted at the time of screening (post-bronchodilator)
• •Evidence of active infection
• •Significant bronchodilator response on screening spirometry, defined as change in FEV1 greater than or equal to 12% and absolute change greater than 200 mL OR change in FVC greater than or equal to 12% and absolute change greater than 200 mL
• •Screening and baseline FVC measurements (in liters, post-bronchodilator) differing by 11%
• •Listed for lung transplantation
• •History of unstable or deteriorating cardiac disease
• •Heart attack, coronary artery bypass, or angioplasty in the 6 months before study entry
• •Unstable angina pectoris or congestive heart failure requiring hospitalization in the 6 months before study entry
• •Uncontrolled arrhythmia
• •Severe uncontrolled high blood pressure
• •Known HIV or hepatitis C
• •Known cirrhosis and chronic active hepatitis
• •Active substance and/or alcohol abuse
• •Pregnant or breastfeeding
• •Women of childbearing potential who are not using a medically approved means of contraception
• •Any clinically relevant lab abnormalities, including the following:
• •1. Creatinine greater than twice the upper limit of normal (ULN)
• •2. Hematology outside of specified limits
• •1. White blood cells less than 3,500/mm3
• •2. Hematocrit less than 25% or greater than 59%
• •3. Platelets less than 100,000 mm3 at the time of screening
• •3. Any of the following liver function test criteria above specified limits
• •1. Total bilirubin greater than twice the ULN
• •2. Aspartate (AST) or alanine aminotransferases (ALT) greater than 1.5 the ULN
• •3. Alkaline phosphatase greater than three times the ULN
• •4. Albumin less than 3.0 mg/dL at the time of screening
• •Known hypersensitivity to study medication
• •Any condition other than IPF that, in the opinion of the site PI, is likely to result in death in the 1 year after study entry
• •Any condition that, in the judgment of the PI, might cause participation in this study to be detrimental or makes the person a poor candidate for the study