Evaluating the Effectiveness of Prednisone, Azathioprine, and N-acetylcysteine in Patients With IPF (PANTHER-IPF)
This study is ongoing, but not recruiting participants.
Sponsor:
Duke University
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00650091
First received: March 28, 2008
Last updated: March 11, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Fibrosis |
Drug: N-acetylcysteine (NAC) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Duke University:
Primary Outcome Measures:
- Change in serial forced vital capacity [ Time Frame: Measured at Week 60 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to disease progression [ Time Frame: Measured at Week 60 ] [ Designated as safety issue: No ]
- Acute exacerbations [ Time Frame: Measured at Week 60 ] [ Designated as safety issue: No ]
- Respiratory infections [ Time Frame: Measured at Week 60 ] [ Designated as safety issue: No ]
- Maintained forced vital capacity response [ Time Frame: Measured at Week 60 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 390 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: Placebo
Participants will receive placebo each day.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 35 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 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:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00650091
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| United States, Alabama | |
| University of Alabama - Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| University of California - Los Angeles | |
| Los Angeles, California, United States, 90095 | |
| University of California - San Francisco | |
| San Francisco, California, United States, 94110 | |
| United States, Colorado | |
| National Jewish Medical and Research Center | |
| Denver, Colorado, United States, 80206 | |
| United States, Connecticut | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Florida | |
| University of Miami Miller School of Medicine | |
| Miami, Florida, United States, 33136 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Kentucky | |
| University of Louisville | |
| Louisville, Kentucky, United States, 40425 | |
| United States, Louisiana | |
| Tulane University | |
| New Orleans, Louisiana, United States, 70118 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| St. Luke's Hospital | |
| Chesterfield, Missouri, United States, 63107 | |
| United States, New York | |
| Weill Medical College of Cornell University | |
| New York, New York, United States, 10021 | |
| Mount Sinai Hospital | |
| New York, New York, United States, 10029 | |
| Highland Hospital - University of Rochester Medical Center | |
| Rochester, New York, United States, 14620 | |
| United States, North Carolina | |
| Duke Universtiy | |
| Durham, North Carolina, United States, 27705 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| University of Pennsylvania Health System | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Temple University | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Vanderbilt University | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| United States, Utah | |
| University of Utah Health Research Center | |
| Salt Lake City, Utah, United States, 84108 | |
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98165 | |
Sponsors and Collaborators
Duke University
Investigators
| 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 |
| 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 |
More Information
Additional Information:
No publications provided by Duke University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00650091 History of Changes |
| Other Study ID Numbers: | Pro00020066, U10HL080413-03 |
| Study First Received: | March 28, 2008 |
| Last Updated: | March 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Duke University:
|
Idiopathic Pulmonary Fibrosis Prednisone Azathioprine NAC N-acetylcysteine |
Additional relevant MeSH terms:
|
Fibrosis Pulmonary Fibrosis Pathologic Processes Lung Diseases Respiratory Tract Diseases Acetylcysteine N-monoacetylcystine Azathioprine Prednisone Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Expectorants Respiratory System Agents |
Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on June 17, 2013