Precision Medicine Zeroes in on COPD Treatment
October 16, 2019
UH participates in four COPD clinical trials covering wide spectrum of patient needs
Innovations in Pulmonology & Sleep Medicine | Fall 2019
About 12 million adults in the United States have diagnosed chronic obstructive pulmonary disease (COPD), according to the National Institutes of Health (NIH), and another 12 million may be undiagnosed. Finding ways to prevent COPD — and effectively treating patients already diagnosed — is a top priority at University Hospitals. To this end, UH is actively recruiting patients for four exciting clinical trials.
“These clinical trials span the whole gamut of active issues for which we’re seeking new knowledge,” explains Rodney Folz, MD, PhD, Chief, Division of Pulmonary, Critical Care and Sleep Medicine, UH Cleveland Medical Center. “Although we have general guidelines for treating COPD, these trials take a more precision medicine approach. In other words, if we can better define the type of COPD a patient has, we can pick individual therapies that may better benefit that patient.”
RETHINC (REdefining THerapy In Early COPD for the Pulmonary Trials Cooperative) seeks to determine if putting undiagnosed but symptomatic smokers (or former smokers) on bronchodilator therapy will prevent them from developing COPD.
“In previous studies, we’ve learned that when we compare smokers with symptoms — such as coughing or shortness of breath with exertion — to smokers who don’t have symptoms, having symptoms is a marker for those patients developing airway obstruction,” explains Dr. Folz. “If we put these smokers on bronchodilator treatments — normally reserved for patients with COPD — can we prevent this high-risk group from developing COPD down the road?
”If this study demonstrates that COPD actually can be prevented or delayed, it will be a major milestone, says Dr. Folz.
RETHINC is funded by the NIH through Case Western Reserve University School of Medicine.
Clinicians have strong data that patients with COPD who are significantly overweight do worse on health outcomes than those with the same severity of COPD but who are not overweight, says Dr. Folz.
Patients enrolled in INSIGHT COPD (Intervention Study In Overweight Patients with COPD) will receive step counters, scales and instructional videos, and they will be assigned a coach. The coach will provide telephone lifestyle support to see if encouraging patients to become more active improves their overall progression of COPD and lung health-related outcome measures.
“While this trial is not right for everybody, it seems particularly relevant to a certain type of person with COPD, someone who is more social and likes having interaction with a coach,” says Dr. Folz.
INSIGHT COPD is funded by the NIH through Case Western Reserve University School of Medicine.
Patients with moderate to severe COPD usually are placed on a single inhaler. If they still have lung symptoms, Dr. Folz says clinicians currently have little guidance as to which inhaler to use next if they want to step up therapy. Current practice is to put all patients on triple inhaler therapy. Furthermore, COPD exacerbations are serious and can permanently compromise lung function, so preventing them is critical.
“AIRWISE randomizes moderate COPD patients to double or triple inhaler therapy,” explains Dr. Folz. “At the end of the trial, we hope to know if patients with certain types of COPD may do just as well on a double inhaler, thus adding benefit without unnecessary side effects.”
AIRWISE (Assessment In a Real World Setting of the Effect of Inhaled Steroid-based Triple Therapy Versus the Combination of Tiotropium and Olodaterol on Reducing Chronic Obstructive Pulmonary Disease Exacerbations) is sponsored by HealthCore, Anthem’s outcome research subsidiary, and Boehringer Ingelheim.
RELIANCE (Roflumilast or Azithromycin to Prevent COPD Exacerbations) compares roflumilast with azithromycin to see if one does a better job of helping patients with the most severe cases of COPD have fewer COPD-related hospitalizations and emergency room visits.
“Although both drugs help minimize COPD attacks and hospitalizations, these two interventions have never compared side by side before,” Dr. Folz says. “Exacerbations are an indicator for high-risk patients not doing well, so determining if one drug might work better in patients with certain types of COPD is important."
RELIANCE is funded through a grant from the Patient Centered Outcomes Research Institute (PCORI). UH is currently prescreening patients, with enrollment scheduled for later in the year.
Together, these trials address a lot of important questions for helping guide more precise care approaches for COPD patients, says Dr. Folz.