Aurora BayCare Medical Center in Green Bay, Wisconsin, is the first site in the state to join a clinical trial evaluating an investigational drug for people with chronic obstructive pulmonary disease, or COPD.
COPD is the third leading cause of death worldwide and the fourth leading cause of death in the U.S., according to the World Health Organization and the U.S. Centers for Disease Control and Prevention.
“COPD actually represents a group of diseases that include chronic bronchitis and emphysema,” said pulmonologist Raul Mendoza-Ayala, MD, Advocate Aurora Research Institute’s principal investigator for the study. “In patients with COPD, the airways in the lungs become inflamed and constricted, causing difficulty breathing.”
Most cases of COPD are caused by long-term exposure to irritants that damage the lungs. About 85 to 90 percent of all cases are caused by cigarette smoking, according to the American Lung Association.
“Quitting smoking can slow a patient’s decline in lung function, but people with COPD are still at high risk of hospitalization,” Dr. Mendoza-Ayala said. “And current medications have shown only a modest effect in treating the disease.”
The clinical trial underway at Aurora BayCare is assessing the effectiveness, safety and tolerability of a new investigational drug for the treatment of COPD in people who continue to have symptoms despite their current treatment and who are in need of additional treatment.
The study drug, itepekimab, is a type of monoclonal antibody treatment that is intended to block a type of protein that causes inflammation.
“Previous studies of itepekimab have demonstrated some ability to prevent worsening of COPD symptoms in former smokers,” said Laura Wrona, MSN, director of specialty clinical trials for the Research Institute. “However, this study will analyze the impact of the study drug in both current and former smokers.”
Researchers at sites throughout the world will enroll approximately 1,200 participants in the clinical trial, known as AERIFY-2, or “Study to assess the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab in chronic obstructive pulmonary disease (COPD).”
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