Does esomeprazole improve symptoms and quality of life in patients with asthma?

In this study, esomeprazole (Nexium) was no better than placebo in improving peak expiratory flow, asthma symptoms, or quality of life in patients with stable asthma. Furthermore, esomeprazole was no better than placebo in patients with reflux, either. (LOE = 2b-)

Kiljander TO, Harding SM, Field SK, et al. Effects of esomeprazole 40 mg twice daily on asthma: a randomized placebo-controlled trial. Am J Respir Crit Care Med 2006;173:1091-1097.  [PMID:16357331]

Randomized controlled trial (double-blinded)

Industry

Uncertain

Outpatient (any)

After completing a run-in period of 11 days to 14 days, these researchers randomized patients with stable asthma already taking adequate control medications (inhaled corticosteroids and/or leukotriene inhibitors) to receive 16 weeks of 40 mg esomeprazole twice daily or placebo. They don't describe if the allocation was concealed. As a planned subanalysis of this study, the investigators also classified patients by the presence or absence of gastroesophageal reflux disease (GERD) or nocturnal symptoms. The authors don't describe if they used an intention to treat approach to evaluate the outcomes: peak expiratory flow rates, symptoms, and quality of life. At the conclusion of the study, there was no significant difference in the main outcomes, use of rescue medication, or other secondary outcomes. Of the various subgroups, only the group with both GERD and nocturnal symptoms had a small increase in peak expiratory flow rate, but no they showed improvement on any of the clinically relevant outcomes. The manufacturer of esomeprazole designed and funded this study. Given the silence on key methodologic issues (masked allocation, intention to treat, and so forth), these data may be biased in favor of the intervention group, making this a truly negative study.