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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Fibrosis

In brief

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 idiopathic pulmonary fibrosis who had mild-to-moderate lung-function impairment to one of three groups - receiving a combination of prednisone, azathioprine, and NAC (combination therapy), NAC alone, or placebo - in a 1:1:1 ratio.

Key facts

Study ID

NCT00650091

Run by

Duke University

People needed

264

Starts

2009-10-01

Expected to finish

2014-01-01

Last updated by the study team

2015-06-02

Who can join

Age: 35 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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%

Where it is running

• University of Alabama - Birmingham — Birmingham, Alabama, United States
• University of California - Los Angeles — Los Angeles, California, United States
• University of California - San Francisco — San Francisco, California, United States
• National Jewish Medical and Research Center — Denver, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• University of Louisville — Louisville, Kentucky, United States
• Tulane University — New Orleans, Louisiana, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• St. Luke's Hospital — Chesterfield, Missouri, United States
• Weill Medical College of Cornell University — New York, New York, United States
• Mount Sinai Hospital — New York, New York, United States
• Highland Hospital - University of Rochester Medical Center — Rochester, New York, United States
• Duke Universtiy — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
• Temple University — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• University of Utah Health Research Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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