Status:
COMPLETED
Evaluating the Effectiveness of Prednisone, Azathioprine, and N-acetylcysteine in Patients With IPF
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Pulmonary Fibrosis
Eligibility:
All Genders
35-85 years
Phase:
PHASE3
Brief Summary
Idiopathic pulmonary fibrosis (IPF) is a long-term lung disease that affects an individual's ability to breathe. In this randomized, double-blind, placebo-controlled trial, we assigned patients with i...
Detailed Description
IPF is a disease with widespread and permanent scarring of lung tissue which eventually results in death. Individuals with IPF may experience breathing difficulties, cough, chest pain, and a decreased...
Eligibility Criteria
Inclusion
- Forced vital capacity (FVC) greater than or equal to 50% of predicted value
- Diffusion capacity (DLCO) greater than or equal to 30% of predicted value
- Diagnosis of IPF by modified American Thoracic Society (ATS) criteria in the 48 months before study entry
Exclusion
- 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:
- Creatinine greater than twice the upper limit of normal (ULN)
- Hematology outside of specified limits
- White blood cells less than 3,500/mm3
- Hematocrit less than 25% or greater than 59%
- Platelets less than 100,000 mm3 at the time of screening
- Any of the following liver function test criteria above specified limits
- Total bilirubin greater than twice the ULN
- Aspartate (AST) or alanine aminotransferases (ALT) greater than 1.5 the ULN
- Alkaline phosphatase greater than three times the ULN
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT00650091
Start Date
October 1 2009
End Date
January 1 2014
Last Update
June 2 2015
Active Locations (26)
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1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
2
University of California - Los Angeles
Los Angeles, California, United States, 90095
3
University of California - San Francisco
San Francisco, California, United States, 94110
4
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206