A placebo-controlled, multicenter, randomized trial to test GKT137831 in ambulatory patients with idiopathic pulmonary fibrosis. This drug is an inhibitor of nicotinamide adenine dinucleotide phosphate (NADPH) oxidase (NOX) isoforms. The investigators hypothesize the drug will decrease pulmonary injury due to reactive oxygen species (ROS) generated by NOX enzymes, which are believed to play an important role in the development of IPF. Treatment with GKT137831 could result in significant benefit for a lung disease that has, until now, been almost invariably inexorable. This clinical trial represents the bedside application of a series of NOX translational and basic studies and discoveries, over several years, from the laboratory of Dr. Victor Thannickal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
58
see Arm/Group description
GKT137831 is a NOX enzyme inhibitor
University of Alabama at Birmingham
Birmingham, Alabama, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Temple University Medical Center
Philadelphia, Pennsylvania, United States
Surrogate Biomarker of Oxidative Stress by Mass Spectroscopy
Changes in concentrations of circulating o,o'-dityrosine, as determined by mass spectroscopy in plasma, in terms of absolute concentrations and percentages of baseline, will be compared within and between treatment arm participants.
Time frame: From baseline thru week 24
Collagen Degradation Product by Enzyme Linked Immunoabsorbant Assay
Changes in concentrations of the collagen degradation product, serum C1M measured by enzyme linked immunsorbent assays will be compared between baseline values and those at 24 weeks, and between experimental arm and control participants.
Time frame: Baseline to week 24
Pulmonary Function by Spirometry
Forced vital capacity (FVC), measured by spirometer at baseline, will be compared to values at the conclusion of the study and between the two treatment arms.
Time frame: Baseline to week 24
Ambulatory Ability by Measuring Walk Distance in Six Minutes
Six-minute walk distance (6MWD) will be compared at baseline and as changes from baseline among experimental arm participants and control subjects
Time frame: Baseline to week 24
Evaluation of Safety by Adverse Events
The number of participants who had adverse events will be compared between experimental arm participants and those in the control arm.
Time frame: Up to week 24
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