Pulmonary Disease

Multi center research project was to determine which of two drugs azithromycin, an antibiotic, or roflumilast, an anti inflammatory medication is the most effective at treating chronic obstructive pulmonary disease; which is also known as COPD. COPD, an umbrella term for a number of lung conditions that make it difficult for a person to breathe, affects 15 million people living in the U.S. and is a leading cause of hospitalizations and death in the country.

Studies of these medications

While the two drugs have both show to help prevent COPD exacerbations; so doctors do not know which drug works best for which patient. Previous studies of these medications have about finding out if they work compare to a placebo pill in highly select patients and study environments, said trial principal investigator Dr. Jerry Krishnan, associate vice chancellor for population health sciences and professor of medicine and public health at UIC.

The clinical trial, known as the RELIANCE study; so is design by researchers with the help of patients, caregivers, professional societies and the COPD Foundation; hence the largest patient advocacy organization for COPD in the U.S. It will follow more than 3,000 patients with COPD for up to three years. Patients will be enrolled at their doctor’s office as they receive their usual COPD care at more than 30 centers across the U.S.

The researchers will track participants’ health by telephone; hence by monitoring their electronic health records and medical and pharmacy claims information. The study will help to determine which medication is more effective; so in reducing the risk of urgent care and emergency room visits, hospitalizations and death. The researchers also will track side effects and indicators of physical and mental health.

Medications head to head

The RELIANCE study will compare the two medications head to head and determine which is best to reduce the risk of death and hospitalization in people with COPD, Krishnan said. Specifically, they want to find out which medication works best for people who are current smokers and for people who are former smokers.

In addition, the researchers will compare the drugs according to gender, comorbid conditions and other patient characteristics. Patients with COPD deserve an individualized treatment plan. The RELIANCE study will help us to do that,” Krishnan said. Other RELIANCE investigators at UIC include Dr. Valentin Prieto Centurion, assistant professor of medicine, and Kim Erwin, co-founder and co-director of the Institute for Healthcare Delivery Design and research professor of design.

Erwin says that RELIANCE is the first clinical trial to integrate a dedicated communication center; so staff by human center design experts, to create patient focus recruitment and retention strategies. This is a rarity in clinical trials, she said. They are extending that design strategy to rethink all trial materials; so that everyone involve patients, families, doctors and study staff proceed with a clear understanding of RELIANCE.

They are also focused on making this a ‘learning trial’ for patients; who tell us that they want to be considered partners and included in trial updates and discoveries as they emerge. To have a communication center dedicate to addressing the real world needs of diverse stakeholders is another unusual feature of RELIANCE, Erwin said.