Published ahead of print on December 15, 2005, doi:10.1164/rccm.200507-1167OC
Am. J. Respir. Crit. Care Med., Volume 173, Number 10, May 2006, 1091-1097
A more recent version of this article appeared on May 15, 2006
Submitted on July 28, 2005
Accepted on December 15, 2005
Effects of Esomeprazole 40 mg Twice Daily on Asthma: A Randomized Placebo-Controlled Trial
Toni O Kiljander1*, Susan M Harding2, Stephen K Field3, Mark R Stein4, Harold S Nelson5, Jan Ekelund6, Marta Illueca7, Ola Beckman6, and Mark B Sostek7
1 Department of Pulmonary Diseases, Tampere University Hospital, Tampere, Finland,
2 Division of Pulmonary, Allergy, and Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA,
3 Division of Respiratory Medicine, Univeristy of Calgary Medical School, Alberta, Canada,
4 Allergy Associates of the Palm Beaches, North Palm Beach, Florida, USA,
5 National Jewish Medical and Research Center, Denver, Colorado, USA,
6 AstraZeneca R & D Lund, Lund, Sweden,
7 AstraZeneca Pharmaceuticals, Wilmington, Delaware, USA
* To whom correspondence should be addressed. E-mail: toni.kiljander{at}fimnet.fi.
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  2-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.
Key words: Asthma, gastroesophageal reflux; gastric acid; peak expiratory flow; proton pump inhibitor
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