(Oakland, CA, April 8, 2009) -- For nearly 20 years, it was believed that severe asthma symptoms such as coughing, wheezing and breathlessness were triggered in part by acid reflux. A new study conducted by the American Lung Association’s Asthma Clinical Research Centers (ACRC, including a location at the University of California at San Diego) finds the longstanding practice of prescribing heartburn medication to be ineffective and unnecessarily expensive for asthma patients who do not exhibit symptoms associated with acid reflux such as heartburn or stomach pain.
Patients participating in the American Lung Association’s ACRC study were randomly given either 80 milligrams of esomeprazole (Nexium) or placebo. Patients in both groups had similar numbers of poor asthma control episodes, and there were no differences in their lung function or other asthma symptoms. These results show that esomeprazole was no more effective than placebo for the treatment of asthma.
The results of this study, which were published today in the New England Journal of Medicine, are considered to be the most comprehensive evaluation to date of the efficacy of prescription heartburn medication to control respiratory flare-ups in asthmatics whose symptoms have not been well controlled by other therapies.
“Each year, people with asthma are spending as much as $10 million dollars on prescription heartburn medication believing it will help control attacks of wheezing, coughing and breathlessness,” said Norman H. Edelman, MD, American Lung Association Chief Medical Officer. “Now we know with confidence that silent acid reflux does not play a significant role in poor asthma control. Talk with your doctor before discontinuing any medication, as each patient’s specific needs will vary.”
For asthma patients with symptoms of gastric reflux such as heartburn that occurs at least twice weekly, the American Lung Association recommends prescription heartburn medication be taken to control heartburn, and not asthma symptoms.
The drug’s manufacturer, AstraZeneca provided the medication for the study that was funded by the American Lung Association and the National Heart, Lung and Blood Institute, a component of the National Institutes of Health. AstraZeneca is the national sponsor of the American Lung Association’s Breathe Well, Live Well: An Asthma Management Program for Adults. This partnership has helped expand the program into diverse communities across the nation.
The ACRC Network is an American Lung Association sponsored research program that conducts large scale clinical trials with the mission of advancing the care and treatment of people with asthma. The network, with a central data coordinating center and 20 clinical centers located across the country, is the largest of its kind. By placing its clinical centers around the country, the ACRC Network is able to enroll large numbers of patients for clinical trials, thus ensuring relevant research findings can be interpreted with the highest level of scientific authority.
ABSTRACT:
Efficacy of Esomeprazole for Treatment of Poorly Controlled Asthma: A Randomized Controlled Trial
Background: Gastroesophageal reflux (GER) is common in asthma patients but often has mild or no symptoms. It is not known whether treatment of GER with proton pump inhibitors (PPIs) in poorly-controlled asthmatics without GER symptoms can substantially improve asthma control.
Methods: 402 asthmatics with inadequate asthma control despite inhaled corticosteroids and absent or minimal GER symptoms were randomly assigned to either esomeprazole 40 mg b.i.d. or matching placebo in a parallel-group double-masked clinical trial. Participants were followed for 24 weeks with daily asthma diaries, every 4-week spirometry, and asthma symptom questionnaires.
Participants were classified with respect to GER status with ambulatory pH probe monitoring. The primary outcome was the rate of episodes of poor asthma control (EPACs) based on asthma diaries.
Results: Episodes of poor asthma control occurred with similar frequency in the placebo and esomeprazole treatment groups (2.4 vs 2.5 events/person-year, respectively, P=0.72). There was no treatment effect with respect to components of the EPACs, or secondary outcomes including pulmonary function, airways reactivity, asthma control, symptom scores, nocturnal awakenings, or quality of life. GER documented by pH probe studies in 40% of participants with absent or minimal symptoms did not identify a subgroup benefitting from PPI treatment. Serious adverse events were fewer with esomeprazole than placebo (11 vs 17).
Conclusion: Despite a high prevalence of asymptomatic GER in patients with poorly controlled asthma, treatment with proton pump inhibitors does not improve control. Silent GER is not a likely cause of poorly controlled asthma.
The University of California at San Diego (UCSD) participated in this research as a clinical center. The leaders of the study at UCSD were Joe Ramsdell, MD and Stephen Wasserman, MD.
Norman H. Edelman, MD, disclosed stock ownership with Johnson & Johnson.
About the American Lung Association:
Now in its second century, the American Lung Association is the leading organization working to save lives by improving lung health and preventing lung disease. With your generous support, the American Lung Association is “Fighting for Air” through research, education and advocacy. For more information about the American Lung Association, a Charity Navigator Four Star Charity and holder of the Better Business Bureau Wise Giving Guide Seal, or to support the work it does, call 1-800-LUNG-USA (1-800-586-4872) or visit www.lungusa.org.
