UIC to lead $13.7M clinical trial of COPD medications
The University of Illinois at Chicago has been awarded a four-year, $13.7 million contract from the Patient-Centered Outcomes Research Institute (PCORI) to lead a multi-center clinical trial of two drugs used to treat chronic obstructive pulmonary disease, or COPD.
A progressive lung disease that makes it hard to breathe, COPD disproportionately affects the elderly, people of low-income and minorities. Smoking is the leading cause of COPD, which affects approximately 15 million Americans and is the third-leading cause of death in the U.S., after heart disease and cancer.
COPD can be managed with medications, but most patients will experience occasional breathing attacks with shortness of breath, coughing with phlegm, and wheezing. These exacerbations can be disabling for days or weeks at a time, and severe attacks result in about 700,000 hospitalizations and 150,000 deaths each year.
The new clinical trial, at 50 U.S. centers, will be led by Dr. Jerry Krishnan, professor of pulmonary care in the UIC College of Medicine, along with co-principal investigators Dr. Robert Wise of the Johns Hopkins School of Medicine and John Walsh, co-founder and president of the COPD Foundation. The trial will compare the benefits and risks of two medications currently used to treat COPD — roflumilast, an anti-inflammatory, and azithromycin, an antibiotic.
Recent clinical trials and guidelines indicate that long-term use of roflumilast or azithromycin, together with commonly prescribed inhaler-based medications, significantly reduces the incidence of dangerous exacerbations. But no studies have compared roflumilast to azithromycin.
“This will be the first head-to-head trial of these two drugs and it will help determine which treatment is best at helping patients with COPD avoid hospitalizations and death,” said Krishnan, who is also associate vice chancellor for health affairs at the University of Illinois Hospital & Health Sciences System.
About half of all COPD patients are current smokers, and most of the rest are former smokers, Krishnan said. The study will help determine which treatment is best for current smokers; which is best for former smokers; and which is best able to help patients maintain their physical, mental and social well-being.
The RofLumilast or Azithromycin to preveNt COPD Exacerbations — or RELIANCE study — will enroll 3,200 adults who have been hospitalized for COPD within the last year. Patients will be followed up for up to three years.
“We congratulate Dr. Krishnan and his colleagues on receiving this prestigious research award from PCORI,” said Dr. Robert Barish, vice chancellor for health affairs at UIC. “COPD is common among the patients we serve, and we look forward to the study results so that patients and their clinicians can make more informed decisions.”
PCORI is an independent nonprofit, nongovernmental organization authorized by Congress in 2010 to fund comparative clinical effectiveness research to help patients, providers and insurers make informed health decisions.
The RELIANCE study is funded through PCORI’s Pragmatic Clinical Studies Initiative, an effort to produce results that are broadly applicable to a diverse range of patients and that can be quickly adopted in routine clinical practice. Pragmatic clinical studies test a treatment’s effectiveness in typical hospitals and outpatient clinics and may include a wider range of participants than other clinical studies, which are often conducted in specialized research centers under ideal conditions.
PCORI’s board approved the award to UIC pending completion of a business and programmatic review by PCORI staff and issuance of the contract.