Asthma and gastroesophageal reflux (GER) are both common illnesses in children. GER in children often occurs without the typical symptoms of heartburn, and physicians frequently prescribe the acid reflux drug lansoprazole to supplement the standard inhaled steroid treatment for children with uncontrolled asthma regardless of GER symptoms. However, a randomized clinic trial conducted by the American Lung Association's Asthma Clinical Group found that the addition of lansoprazole does not improve asthma symptoms or the control of asthma in children and may increase the risk for upper respiratory infections and other adverse events.
Results of the study appear in the January 25 issue of JAMA.
Lansoprazole belongs to a class of drugs called proton pump inhibitors (PPIs) that reduce acid in the stomach. Use of these drugs, including for the treatment of asthma symptoms, has risen dramatically in children over the last decade.
"The data were very clear. Lansoprazole did not improve asthma symptoms in children as compared to a placebo, and there is no evidence to support prescribing these drugs to treat asthma in children," said Janet Holbrook, PhD, corresponding author of the study and associate professor in the Department of Epidemiology at the Johns Hopkins Bloomberg School of Public Health. "In our study, children taking lansoprazole showed an increased risk for respiratory infection, sore throats and bronchitis." The Bloomberg School's Center for Clinical Trials served as data coordinating center for the research team.
For the study, researchers from 18 trial sites studied 306 children ages 6 to 17 years. All study participants had inadequately controlled asthma despite taking inhaled corticosteroids but did not have the typical symptoms of GER.
Approximately 40 percent of participants were identified as having GER based on diagnostic testing. The participants were randomly selected to receive either a daily dose of lansoprazole or a placebo pill over a 24-week period in addition to their inhaled steroid therapy.
The researchers found no significant differences in severity of asthma symptoms or overall lung function between the group taking lansoprazole and the group receiving the placebo, including in the children positively identified as having GER. An earlier separate study of adults conducted by the same research team showed similar results.
The study was funded by the National Heart, Lung, and Blood Institute (NHLBI), which is part of the National Institutes of Health.
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