Adding the acid reflux drug lansoprazole to a standard inhaled steroid treatment for asthma does not improve asthma control in children who have no symptom of acid reflux, according to a new study funded in part by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health. Lansoprazole therapy slightly increased the risk of sore throats and other respiratory problems in children, however.
Results of this study, which was also sponsored by the American Lung Association (ALA), will appear Jan. 25 in the Journal of the American Medical Association.
"This important finding could help prevent giving unnecessary medication to children," said Susan B. Shurin, M.D., acting director of the NHLBI and a board-certified pediatrician. "Doctors have suspected that acid reflux that does not cause symptoms interferes with asthma control and should be treated. This study shows that acid reflux medication should not be given to children for possible silent reflux in hopes of improving asthma control."
Shurin added that a previous NHLBI/ALA-funded trial from 2009 found that acid reflux drugs do not improve asthma control in adults who do not have symptoms of acid reflux.
Acid reflux occurs when stomach acid escapes to the adjoining esophagus. This condition occurs commonly in children and adults with asthma, although sometimes it can be silent and show none of the obvious symptoms such as heartburn, vomiting, and difficulty swallowing. Lansoprazole suppresses the production of stomach acid.
To test whether reflux treatment improves asthma control in children, researchers at 18 ALA Asthma Clinical Research Centers across the United States studied 306 children and teenagers of various ethnicities aged 6-17 years. All study participants had inadequately controlled asthma despite taking inhaled corticosteroids. Approximately 40 percent of tested participants were identified as having acid reflux. Each participant was randomly assigned to receive a daily dose of lansoprazole or an inactive placebo pill along with their inhaled steroid therapy.
After 24 weeks of treatment, there were no significant differences in severity of asthma symptoms, overall lung function, or asthma-related quality of life between the lansoprazole and placebo treatment groups. These similar results were seen both in the whole study group as well as among the study subgroup that was positively identified as having acid reflux.
Children in the lansoprazole group did report more frequent adverse effects such as sore throat (52 percent versus 39 percent in placebo), upper respiratory infection (63 percent versus 49 percent) and/or bronchitis (7 percent versus 2 percent).
"This study addresses an important knowledge gap identified in the asthma guidelines," noted James P. Kiley, Ph.D., director of the NHLBI's Division of Lung Diseases. "This study, as well as the previous reflux trial in adults, will inform future guidelines for the treatment of asthma."
In the United States, asthma affects more than 7 million children and teenagers under age 18 years. Asthma disproportionately affects minorities and those with lower incomes. There is no cure for asthma, but guideline-based treatment can help prevent symptoms and attacks (shortness of breath, wheezing, and chest tightness) and enable children with asthma to lead active lives.
The lansoprazole and placebo used in the study was provided by its manufacturer, Takeda Pharmaceuticals, North America. In addition, GlaxoSmithKline provided Albuterol HFA, a bronchodilator that was used in the evaluation of study participants.
To schedule an interview with an NHLBI spokesperson, contact the NHLBI Communications Office at 301-496-4236 or NHLBI_News@nhlbi.nih.gov.
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- The study of acid reflux therapy for children with asthma (SARCA) at clinicaltrials.gov:
- Acid Reflux without Symptoms Does Not Worsen Asthma in adults
- Guidelines for the Diagnosis and Management of Asthma (EPR-3)
- Health Topic: gastroesophageal reflux