It has been reported that asymptomatic gastro-oesophageal reflux (GOR) is prevalent in children with asthma but it is not known whether treatment with proton pump inhibitors improves asthma control in children without overt GOR despite inhaled corticosteroid treatment.
The Study of Acid Reflux in Children With Asthma, a randomised, masked, placebo-controlled, clinical trial compared lansoprazole with placebo in children with poor asthma control who were receiving inhaled corticosteroid treatment. A total of 306 participants (mean age,11 years: SD, 3 years) from 19 US academic clinical centers were randomised to either lansoprazole, 15 mg/day if weighing less than 30 kg or 30 mg/day if weighing 30 kg or more (n = 149), or placebo (n = 157).
The children were followed up for 24 weeks and assessed for the primary outcome measure, change in Asthma Control Questionnaire (ACQ) score (range, 0-6; a 0.5-unit change is considered clinically meaningful).
The following results were reported:
• 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 subgroup of 115 children with esophageal pH studies, the prevalence of GOR 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]).
The researchers concluded that the addition of lansoprazole, compared with placebo, improved neither symptoms nor lung function but was associated with increased adverse events in children with poorly controlled asthma without symptoms of GOR who were using inhaled corticosteroids.
An accompanying editorial discusses the findings of this study.