Pulmonary Fibrosis Clinical Trial
Official title:
Prednisone, Azathioprine, and N-acetylcysteine: A Study That Evaluates Response in IPF
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.
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 exercise capacity. Although the cause of IPF is unknown, it may be a
result of an inflammatory response to an unknown substance. 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.
In the initial double-blind, placebo-controlled trial, subjects who have idiopathic
pulmonary fibrosis with mild-to-moderate impairment in pulmonary function are randomly
assigned to receive a three-drug regimen of prednisone, azathioprine, and acetylcysteine;
acetylcysteine alone; or placebo.
After safety concerns were identified by the data and safety monitoring board, the
three-drug regimen was stopped by the National Heart, Lung, and Blood Institute (NHLBI) on
October 14, 2011, and a clinical alert was issued. After a brief period of interruption for
modification of the protocol and approval by the institutional review boards, patients
continued to be recruited for the acetylcysteine group and the placebo group and were
followed for the pre-specified duration of 60 weeks.
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, and
questionnaires to assess health status, breathing, and quality of life. Participants will
record medication usage and symptoms in a daily diary.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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