COPD Industry Report
Researchers are furiously jockeying to pull back the reins on chronic obstructive pulmonary disease which has already galloped into the triple crown of mortality. According to the Centers for Disease Control, COPD has nosed-out strokes to become the third leading cause of death in the U.S., a decade earlier than anticipated. Only heart disease and cancer are outpacing it.
If there is a dark horse on this perilous track, it is funding.
"Research is still way underfunded," said Stephen Rennard, MD, professor of medicine at the University of Nebraska. "COPD is the third leading cause of death but probably about 12th in terms of research funding. On a per capita basis it's way, way down the list."
However inadequate the dollars might be in light of the immensity of the disease, there is indeed important research under way. Teamed with the sense of urgency that surrounds such a huge public health menace, medical science is helping to poke holes into the heft of COPD.
Dr. Rennard is chairman of the steering committee for SPIROMICS, an acronym for Subpopulation and Intermediate Outcome Measures in COPD Study. It is anticipated that this new study supported by and under the auspices of the National Heart, Lung, and Blood Institute (NHLBI) will help change the way scientists and physicians see COPD.
"The project is designed to help us understand the heterogeneity of COPD," Dr. Rennard said. "Our research is coming from the position that there is a genetic predisposition to COPD, and not everyone's COPD is exactly the same. We know COPD is a collection of things and all patients are different. But exactly in which ways is not very well understood."
The study, which began about a year ago, now is actively enrolling 3,200 participants in hopes of identifying people in COPD subtypes. Also central to the study will be the identification of specific biomarkers that can be used both to gauge those subtypes and to determine if people are getting better or worse.
When the findings of SPIROMICS begin to emerge, Dr. Rennard expects the ongoing "lumping together" of all COPD patients will be a thing of the past. "We hope to move treatment to an individualized basis," he said. "Personalized medicine is the ideal; that's exactly what this is all about."
Another study emerging from the notion of genetic COPD subtypes is "groundbreaking," according to Ifdy Perez, assistant director of communications for the COPD Foundation in Washington, D.C. More than 10,000 subjects have been recruited over 2 ½ years for the COPDGene study supported by the NHLBI and led by James Crapo, MD, of National Jewish Medical and Research Center in Denver and Edwin Silverman, MD, PhD, of Brigham and Women's Hospital in Boston.
The study will investigate the genetic epidemiology of COPD and find genes that create a risk for developing the disease.
"This disease has an incredibly powerful genetic underpinning; it has to, when only one in five smokers actually gets it," explained James Kiley, PhD, director of the NHLBI's Division of Lung Diseases. He described the COPDGene study as "a gene discovery program, looking for novel variances," and explained that genetic susceptibility in patients will be explored by using a patient's genetic information and correlating it with CT images that characterize that patient.
While the study is still in its early stages, some information is already emerging.
"We've already learned how extremely heterogeneous this population of patients is. It's not just one disease that is straightforward and easy to diagnose and treat," Dr. Kiley said. And while providers have known this for awhile, the COPDGene study enables investigators to correlate genetic variances with the radiologic images.
"As the pathways, the pathobiology, the mechanisms, and the targets unique to a particular type of COPD begin to surface, we eventually will see if there are ways to tailor particular drugs, small molecules, or stem cells toward bringing effective therapies to this disease," Dr. Kiley explained.
Furthermore, the study aims to find a genetic means to identify patients earlier, "way before you see symptoms or currently get a diagnosis," Dr. Kiley said. "We want information that will transfer into the clinic and help patients in real time."
The linking of better disease characterization, earlier diagnosis, and therapies targeted to different phenotypes might indeed bring the medical profession a breakthrough - a new and hopeful way to approach the disease.
"We've laid out a vision, set goals, and are pushing for better understanding," Dr. Kiley said. "In the past, there wasn't too much in the medical toolbox for COPD. That is unacceptable; that has to be turned around."
The Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-Points (ECLIPSE) study, an extensive research program sponsored by GlaxoSmithKline, was designed to advance understanding of the underlying mechanisms of COPD.
In the three-year observational study, researchers found that the single strongest predictor of COPD exacerbations is a prior history of exacerbation, observed across all patients - whether in different stages of COPD, affected by different comorbidities, and across both genders - regardless of disease severity.
Findings released in 2010 suggested that the "frequent exacerbator" is a distinct phenotype of patient who could be identified and targeted with specific exacerbation-prevention strategies. The research speaks yet again to the need for highly personalized medicine to be added to that aforementioned toolbox.
Importance of drug studies
Mega drug/drug use studies of recent years - Towards a Revolution in COPD Health (TORCH) and Understanding Potential Long-term Improvements in Function with Tiotropium (UPLIFT) - continue to help clinicians assess appropriate medications for patients.
The TORCH clinical trial investigated the combination of salmeterol/fluticasone propionate across three years in patients with COPD. Findings suggested that pharmacotherapy reduces the risk of dying (by 17.5 percent) in patients with moderate to severe COPD. Furthermore, the combination was shown to have a significant effect on improvement of quality of life and respiratory function, and a reduction in the rate of exacerbations.
And while previous studies have suggested that long-term use of beta agonists may increase the risk of adverse cardiovascular events, analysis of the three-year data by researchers at the University Hospital Aintree in Liverpool, UK, showed no increase in cardiovascular events.
The UPLIFT trial looked at the long-term effect of tiotropium on COPD patients, and it concluded that users experienced a 16 percent decrease in the risk of death, sustained improvements in lung functions for up to four years, and reduced respiratory and cardiac morbidity, pointing to the safety of tiotropium. Users also experienced improved quality of life, as measured by St. George's Respiratory Questionnaire.
Bringing it all together
"I'm overwhelmed with all that is happening in COPD research," Perez said. "There are thousands of COPD-related scientific research projects going on around the world sponsored by governments, the pharmaceutical industry, academia."
Clearly, the race is on, and COPD researchers are helping to change the odds. The payout in the end? Better understanding, better therapies, and better health.
Contact Valerie Neff Newitt at firstname.lastname@example.org.