COLUMBUS, Ohio – The connection between asthma and acid reflux – and the expectation that reflux will worsen asthma symptoms – has been suspected by asthma specialists for decades, but good evidence to support this notion currently doesn’t exist.
A new national multicenter study led by pulmonary researchers at Ohio State University Medical Center aims to determine whether treating acid reflux – suffered by up to 35 percent of asthmatics – could play a role in relieving asthma symptoms, especially by reducing the frequency of asthma attacks.
“We’ve known for quite awhile that patients with asthma who also have acid reflux tended to do worse, but there hasn’t been much science behind the relationship,” said Dr. John Mastronarde, a pulmonologist at OSU Medical Center and director of its asthma center. “Whether patients with asthma respond to acid reflux treatment is an important question to answer and has the potential to really improve patients’ quality of life.”
Mastronarde is the project leader for the trial and OSU Medical Center is the lead center among 20 universities nationally that are currently enrolling adult patients with known asthma for six months to see if taking a proton pump inhibitor can alleviate asthma symptoms. Proton pump inhibitors act by preventing the release of acid in the stomach and intestines. The researchers plan to enroll almost 500 patients in the trial, called SARA (study of acid reflux and asthma).
Patients don’t even have to know whether they have acid reflux, also called gastroesophageal reflux disease, or GERD, because up to 20 percent of asthma patients with reflux have a latent form of the disorder and don’t feel heartburn symptoms.
Research participants will be randomized to receive either 40 milligrams of the proton pump inhibitor esomeprazole (marketed under the brand name Nexium) or a placebo and then tracked to determine if their asthma symptoms improve. Researchers will ask a series of questions about symptoms and quality of life issues, monitor patients’ lung function and measure acid in their esophagus.
“That way, we’ll know for sure whether they have acid reflux or not,” Mastronarde said. “Patients who have the silent form of acid reflux and don’t know it could have problems, because they’re likely taking more asthma medicine than they need and taking that extra medication isn’t really helping.”
Mastronarde cautioned, however, that this research is needed to determine whether the proton pump inhibitor offers benefits to asthma patients that outweigh any risks of taking additional medicine that could cause side effects or interact with other drugs.
“If the proton pump inhibitor works, it will be pretty significant because it will give clinicians more guidelines about which asthma patients should be treated for reflux and allow us to be more precise in our treatment. Equally important is determining which patients should not get that medicine if they don’t need it,” he said.
He said animal studies have produced theories about the association between the two disorders, but no definite answers. Theories suggest acid in the esophagus can trigger asthmatic airways to contract or affect nerves that trigger coughing, or that acid is aspirated into the lungs.
About 20 million Americans have asthma, characterized by coughing, wheezing, tightness in the chest and shortness of breath. Treatment often involves a combination of quick-relief medicines to dilate constricted airways and long-term medications that reduce inflammation or relax muscles. Mastronarde said the combination of medication and education about how to control asthma allows the majority of asthma patients to live a normal life. However, the disease is responsible for between 4,000 and 5,000 deaths in the United States each year.
The SARA trial is jointly funded by the American Lung Association and the National Institutes of Health. Mastronarde co-authored the study protocol with principal investigator Dr. Robert Wise of Johns Hopkins University School of Public Health, which is the data-coordinating center for the study.
OSU Medical Center’s adult asthma clinical research center, based in the Dorothy M. Davis Heart and Lung Research Institute, is one of the few nationally aligned with a pediatric center, which is based at Columbus Children’s Hospital and directed by Dr. Karen McCoy. OSU’s asthma center also has a patient care clinic at the Martha Morehouse Medical Plaza, with several individualized treatment programs for patients with asthma.
The adult asthma clinical research center at OSU Medical Center is currently conducting additional clinical trials concerning asthma treatment and control. Patients with asthma who are interested in learning more about ongoing clinical trials should call the asthma clinical research center at 614-293-4978
or send an e-mail to Lung.Research@osumc.edu
Patient appointments for the adult asthma clinic can be made by calling 614-293-4925
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Medical Center Communications