Clinical Question: Does esomeprazole (Nexium) improve symptoms and quality of life in patients with asthma?

Setting: Outpatient (any)

Study Design: Randomized controlled trial (double-blinded)

Synopsis: After completing a run-in period of 11 to 14 days, the 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 do not specify 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 do not 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 GERD and nocturnal symptoms had a small increase in peak expiratory flow rate, but these patients showed no improvement on any of the clinically relevant outcomes. The manufacturer of esomeprazole designed and funded this study. Given the lack of key methodologic issues (e.g., masked allocation, intention to treat), these data may be biased in favor of the intervention group, making this a truly negative study.

Bottom Line: In this study, esomeprazole 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 GERD. (Level of Evidence: 2b–)