Efficacy of esomeprazole for treatment of poorly controlled asthma
Efficacy of Esomeprazole for Treatment of Poorly
The American Lung Association Asthma Clinical Research Centers
Gastroesophageal reflux is common among patients with
asthma but often causes mild or no symptoms. It is not known whether treatment of
gastroesophageal reflux with proton-pump inhibitors in patients who have poorly
controlled asthma without symptoms of gastroesophageal reflux can substantially
improve asthma control.
In a parallel-group, double-blind trial, we randomly assigned 412 participants with inadequately controlled asthma, despite treatment with inhaled corticosteroids, and with minimal or no symptoms of gastroesophageal reflux to receive either 40 mg of esomeprazole twice a day or matching placebo. Participants were followed for 24 weeks with the use of daily asthma diaries, spirometry performed once every 4 weeks, and questionnaires that asked about asthma symptoms. We used ambulatory pH monitoring to ascertain the presence or absence of gastroesophageal reflux in the participants. The primary outcome was the rate of episodes of poor asthma control, as assessed on the basis of entries in asthma diaries.
Episodes of poor asthma control occurred with similar frequency in the placebo and esomeprazole groups (2.3 and 2.5 events per person-year, respectively; P=0.66). There was no treatment effect with respect to individual components of the episodes of poor asthma control or with respect to secondary outcomes, including pulmonary function, airway reactivity, asthma control, symptom scores, nocturnal awakening, or quality of life. The presence of gastroesophageal reflux, which was documented by pH monitoring in 40% of participants with minimal or no symptoms, did not identify a subgroup of patients that benefited from treatment with proton-pump inhibitors. There were fewer serious adverse events among patients receiving esomeprazole than among those receiving placebo (11 vs. 17).
Despite a high prevalence of asymptomatic gastroesophageal reflux among patients with poorly controlled asthma, treatment with proton-pump inhibitors does not improve asthma control. Asymptomatic gastroesophageal reflux is not a likely cause of poorly controlled asthma. (ClinicalTrials.gov number, NCT00069823 .)
The members of the writing committee of the American Lung Association Asthma Clinical Research Centers
(John G. Mastronarde, M.D., Ohio State University Medical College, Columbus; Nicholas R. Anthonisen, M.D.,
Faculty of Medicine, University of Manitoba, Winnipeg, Canada; Mario Castro, M.D., Washington University
School of Medicine, St. Louis; Janet T. Holbrook, M.P.H., Ph.D., Bloomberg School of Public Health, Johns
Hopkins University, Baltimore; Frank T. Leone, M.D., University of Pennsylvania School of Medicine,
Philadelphia; W. Gerald Teague, M.D., Emory University School of Medicine, Atlanta; and Robert A. Wise,
M.D., Johns Hopkins University School of Medicine, Baltimore) take responsibility for the scientific content and
integrity of the article.
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