Lansoprazole for children with poorly controlled asthma: a randomized controlled trial.

Abstract

CONTEXT:

Asymptomatic gastroesophageal reflux (GER) is prevalent in children with asthma. 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.

OBJECTIVE:

To determine whether lansoprazole is effective in reducing asthma symptoms in children without overt GER.

DESIGN, SETTING, AND PARTICIPANTS:

The Study of Acid Reflux in Children With Asthma, a randomized, masked, placebo-controlled, parallel clinical trial that compared lansoprazole with placebo in children with poor asthma control who were receiving inhaled corticosteroid treatment. Three hundred six participants enrolled from April 2007 to September 2010 at 19 US academic clinical centers were followed up for 24 weeks. A subgroup had an esophageal pH study before randomization.

INTERVENTION:

Participating children were randomly assigned to receive either lansoprazole, 15 mg/d if weighing less than 30 kg or 30 mg/d if weighing 30 kg or more (n = 149), or placebo (n = 157).

MAIN OUTCOME MEASURES:

The primary outcome measure 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.

RESULTS:

The mean age was 11 years (SD, 3 years). The mean difference in change (lansoprazole minus placebo) in the ACQ score was 0.2 units (95% CI, 0.0-0.3 units). There were no statistically significant differences in the mean difference in change for the secondary outcomes of forced expiratory volume in the first second (0.0 L; 95% CI, -0.1 to 0.1 L), asthma-related quality of life (-0.1; 95% CI, -0.3 to 0.1), or rate of episodes of poor asthma control (relative risk, 1.2; 95% CI, 0.9-1.5). Among the 115 children with esophageal pH studies, the prevalence of GER was 43%. In the subgroup with a positive pH study, no treatment effect for lansoprazole vs placebo was observed for any asthma outcome. Children treated with lansoprazole reported more respiratory infections (relative risk, 1.3 [95% CI, 1.1-1.6]).

CONCLUSION:

In this trial of children with poorly controlled asthma without symptoms of GER who were using inhaled corticosteroids, the addition of lansoprazole, compared with placebo, improved neither symptoms nor lung function but was associated with increased adverse events.

TRIAL REGISTRATION:

clinicaltrials.gov Identifier: NCT00442013.

• Authors: Writing Committee for the American Lung Association Asthma Clinical Research Centers, Janet T Holbrook, Robert A Wise, Benjamin D Gold, Kathryn Blake, Ellen D Brown, Mario Castro, Allen J Dozor, John J Lima, John G Mastronarde, Marianna M Sockrider, W Gerald Teague
• Journal: JAMA (JAMA) Vol. 307 Issue 4 Pg. 373-81 (Jan 25 2012) ISSN: 1538-3598 [Electronic] United States
• PMID: 22274684 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• 2-Pyridinylmethylsulfinylbenzimidazoles
• Adrenal Cortex Hormones
• Enzyme Inhibitors
• Proton Pump Inhibitors
• Lansoprazole

Topics

• 2-Pyridinylmethylsulfinylbenzimidazoles (adverse effects, therapeutic use)
• Administration, Inhalation
• Adolescent
• Adrenal Cortex Hormones (administration & dosage)
• Asthma (drug therapy, physiopathology)
• Child
• Double-Blind Method
• Enzyme Inhibitors (adverse effects, therapeutic use)
• Female
• Gastroesophageal Reflux
• Humans
• Lansoprazole
• Lung (drug effects, physiopathology)
• Male
• Proton Pump Inhibitors
• Quality of Life
• Respiratory Function Tests
• Respiratory Tract Infections (chemically induced)
• Treatment Outcome