Adding Proton Pump Inhibitor to Treat Poorly Controlled Asthma in Children Does Not Improve Symptoms

Children without symptoms of gastroesophageal reflux whose asthma was being poorly controlled with anti-inflammatory treatment did not have an improvement in symptoms or lung function with the added treatment of the proton pump inhibitor lansoprazole, compared to patients who received placebo, according to a study in the January 25 issue of JAMA. Use of lansoprazole was associated with increased adverse events.

"Asthma and gastroesophageal reflux (GER) disease are both common disorders in children, and symptoms of GER are frequently reported among children with asthma," according to background information in the article. "Untreated GER has been postulated to be a cause of inadequate asthma control in children despite inhaled corticosteroid treatment, but it is not known whether treatment with proton pump inhibitors improves asthma control."

Janet T. Holbrook, M.P.H., Ph.D., of the Johns Hopkins Bloomberg School of Public Health, Baltimore, and colleagues with the Writing Committee for the American Lung Association Asthma Clinical Research Centers, conducted a randomized, placebo-controlled clinical trial to compare the PPI lansoprazole with placebo in children with poor asthma control who were receiving inhaled corticosteroid treatment.

The study included 306 participants, enrolled from April 2007 to September 2010 at 19 U.S. academic clinical centers, who were followed up for 24 weeks. A subgroup had an esophageal pH (a test for GER) study before randomization. Children were randomly assigned to receive either lansoprazole (n=149) or placebo (n=157). The primary measured outcome was change in Asthma Control Questionnaire (ACQ) score (range, 0-6; a 0.5-unit change is considered clinically meaningful). Secondary outcome measures included lung function measures, asthma-related quality of life, and episodes of poor asthma control. The average age of the children was 11 years; there were more boys than girls, and 50 percent of participants were black.

The researchers found that after randomization, the ACQ score decreased by less than the meaningful clinically important difference in both groups; the change was not statistically different between treatment groups. There were no statistically significant treatment effects for any of the secondary outcomes.

Proton pump inhibitor (PPI) treatment doesn't ease asthma for children who don't have gastroesophageal reflux symptoms, even for those with a positive pH test, a randomized trial determined.

Asthma control scores improved with daily lansoprazole (Prevacid) treatment by only a slight and nonsignificant 0.2 units over that with placebo, Janet T. Holbrook, MPH, PhD, of Johns Hopkins School of Public Health in Baltimore, and colleagues found.

Moreover, the PPI boosted respiratory infection risk by a significant 30%, the researchers reported in the January 25 issue of the Journal of the American Medical Association.