Effects of Esomeprazole 40 mg Twice Daily on Asthma: A Randomized Placebo-Controlled Trial.

Author(s): Kiljander TO, Harding SM, Field SK, Stein MR, Nelson HS, Ekelund J, Illueca M, Beckman O, Sostek MB

Affiliation(s): Department of Pulmonary Diseases, Tampere University Hospital, Tampere, Finland.

Publication date & source: 2005-12-15, Am J Respir Crit Care Med., [Epub ahead of print]

Publication type:

Rationale: Gastroesophageal reflux disease (GERD) is common in asthmatics, suggesting an interaction between the two conditions. Objectives: To assess the effect of gastric acid suppression with the proton pump inhibitor, esomeprazole, on asthma outcomes in subjects with persistent moderate-to-severe asthma treated with anti-inflammatory asthma medication. Methods: In this double-blind study, subjects were randomized to receive esomeprazole 40 mg or placebo twice daily (bid) for 16 weeks. According to nocturnal respiratory symptoms (NOC) and GERD, subjects were divided into three strata: GERD-/NOC+, GERD+/NOC-, and GERD+/NOC+. Measurements and Main Results: 770 subjects were randomized. There was no statistically significant improvement in morning peak expiratory flow (PEF) over placebo in the overall study population: 6.3 L/min (P=.061). Over the whole treatment period, in GERD+/NOC+ subjects (n=350), esomeprazole provided a 8.7 L/min improvement (P=.03) in morning PEF, and a 10.2 L/min improvement (P=.012) in evening PEF over placebo. Among 307 subjects taking long-acting beta2-agonists (LABAs), improvements over placebo were observed in morning PEF (12.2 L/min, P=.017) and in evening PEF (11.1 L/min, P=.024); these improvements were more pronounced in GERD+/NOC+ subjects. Esomeprazole 40 mg bid was well tolerated and no safety concerns were noted. Conclusions: Esomeprazole improved PEF, in asthmatic subjects who presented with both GERD and NOC. In subjects without both GERD and NOC, no improvement could be detected.