|Sponsor:||National Heart, Lung, and Blood Institute (NHLBI)|
|Information provided by (Responsible Party):||National Heart, Lung, and Blood Institute (NHLBI)|
Idiopathic pulmonary fibrosis (IPF) is a long-term lung disease that affects an individual's ability to breathe. This study will evaluate the effectiveness of the antioxidant N-acetylcysteine (NAC), at preventing the loss of lung function in people with IPF.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Prednisone, Azathioprine, and N-acetylcysteine: A Study That Evaluates Response in IPF|
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Participants will receive N-acetylcysteine (NAC) for 60 weeks.
Drug: N-acetylcysteine (NAC)
Participants will receive 600 mg of NAC three times a day.
Placebo Comparator: 2
Participants will receive placebo for 60 weeks.
Participants will receive placebo each day.
IPF is a disease in which fibrous tissue clogs and damages the air sacs within the lungs. Widespread and permanent scarring and stiffening of lung tissue eventually results. Individuals with IPF may experience breathing difficulties, cough, chest pain, and a decreased exercise capacity. Although the cause of IPF is not definitively known, it may be a result of an inflammatory response to an unknown substance. There is no cure for IPF, and no approved treatment for the disease. NAC, an antioxidant that is effective at loosening up mucus that forms in the lungs, may improve lung function. The purpose of this study is to evaluate the effectiveness of NAC at preventing the loss of lung function in people with IPF.
This study will enroll people with mild to moderate IPF. Participants will be randomly assigned to receive for 60 weeks either NAC alone or placebo. Study visits will occur at baseline and Weeks 4, 15, 30, 45, and 60. At all study visits, a physical exam and blood collection will occur. At selected visits, the following study procedures will occur: lung function testing; urine collection; a 6-minute walk test, which will measure the distance walked in a 6-minute period; and questionnaires to assess health status, breathing, and quality of life. Participants will record medication usage and symptoms in a daily diary. Study researchers will review medical records and the Social Security death index 5 years after the end of the study to determine the incidence of death among study participants.
|Study Chair:||Marvin I Schwarz, MD||University of Colorado, Denver|
|Principal Investigator:||Kevin Brown, MD||National Jewish Health|
|Principal Investigator:||Rob Kaner, MD||Weill Medical College at Cornell University|
|Principal Investigator:||Talmadge King, MD||University of California, San Francisco|
|Principal Investigator:||Joe Lasky, MD||Tulane University School of Medicine|
|Principal Investigator:||James Loyd, MD||Vanderbilt University|
|Principal Investigator:||Fernando Martinez, MD||University of Michigan|
|Principal Investigator:||Imre Noth, MD||University of Chicago|
|Principal Investigator:||Ganesh Raghu, MD||University of Washington|
|Principal Investigator:||Jesse Roman, MD||Emory University|
|Principal Investigator:||Jay Ryu, MD||Mayo Clinic|
|Principal Investigator:||John Belperio, MD||University of California, Los Angeles|
|Principal Investigator:||Kevin Anstrom, PhD||Duke University|
|Study Director:||Gail Weinmann, MD||National Heart, Lung, and Blood Institute (NHLBI)|
|Principal Investigator:||Jeffrey Chapman, MD||The Cleveland Clinic|
|Principal Investigator:||Lake Morrison, MD||Duke University|
|Principal Investigator:||Michael Kallay, MD||Highland Hospital|
|Principal Investigator:||Steven Sahn, MD||Medical University of South Carolina|
|Principal Investigator:||Marilyn Glassberg, MD||University of Miami|
|Principal Investigator:||Milton Rossman, MD||University of Pennsylvania|
|Principal Investigator:||John Fitzgerald, MD||University of Texas|
|Principal Investigator:||Mary Beth Scholand, MD||University of Utah|
|Principal Investigator:||Neil Ettinger, MD||St Luke's Hospital|
|Principal Investigator:||Danielle Antin-Ozerkis, MD||Yale University|
|Principal Investigator:||Joao deAndrade, MD||University of Alabama at Birmingham|
|Principal Investigator:||Ivan Rosas, MD||Brigham and Women's|
|Principal Investigator:||Joseph Zibrak, MD||Beth Isreal-Deaconess|
|Principal Investigator:||Gerald Criner, MD||Temple University|
|Principal Investigator:||Maria Padilla, MD||Mount Sinai Hospital, New York|