Efficacy of esomeprazole for treatment of poorly controlled asthma

The American Lung Association Asthma Clinical Research Centers

Research output: Contribution to journalArticle

274 Citations (Scopus)

Abstract

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.)

Original languageEnglish (US)
Pages (from-to)1487-1499
Number of pages13
JournalNew England Journal of Medicine
Volume360
Issue number15
DOIs
StatePublished - Apr 9 2009
Externally publishedYes

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Esomeprazole
Asthma
Gastroesophageal Reflux
Proton Pump Inhibitors
Placebos
Therapeutics
Ambulatory Monitoring
Spirometry

ASJC Scopus subject areas

  • Medicine(all)

Cite this

The American Lung Association Asthma Clinical Research Centers (2009). Efficacy of esomeprazole for treatment of poorly controlled asthma. New England Journal of Medicine, 360(15), 1487-1499. https://doi.org/10.1056/NEJMoa0806290

Efficacy of esomeprazole for treatment of poorly controlled asthma. / The American Lung Association Asthma Clinical Research Centers.

In: New England Journal of Medicine, Vol. 360, No. 15, 09.04.2009, p. 1487-1499.

Research output: Contribution to journalArticle

The American Lung Association Asthma Clinical Research Centers 2009, 'Efficacy of esomeprazole for treatment of poorly controlled asthma', New England Journal of Medicine, vol. 360, no. 15, pp. 1487-1499. https://doi.org/10.1056/NEJMoa0806290
The American Lung Association Asthma Clinical Research Centers. Efficacy of esomeprazole for treatment of poorly controlled asthma. New England Journal of Medicine. 2009 Apr 9;360(15):1487-1499. https://doi.org/10.1056/NEJMoa0806290
The American Lung Association Asthma Clinical Research Centers. / Efficacy of esomeprazole for treatment of poorly controlled asthma. In: New England Journal of Medicine. 2009 ; Vol. 360, No. 15. pp. 1487-1499.
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AU - The American Lung Association Asthma Clinical Research Centers

AU - Mastronarde, John G.

AU - Anthonisen, Nicholas R.

AU - Castro, Mario

AU - Holbrook, Janet T.

AU - Leone, Frank T.

AU - Teague, W. Gerald

AU - Wise, Robert A.

AU - Hanania, N. A.

AU - Sockrider, M.

AU - Giraldo, L.

AU - Valdez, R.

AU - Flores, E.

AU - Reibman, J.

AU - DiMango, E.

AU - Rogers, L.

AU - Cammarata, C.

AU - Carapetyan, K.

AU - Sormillon, J.

AU - Simpson, E.

AU - Williams, L.

AU - Sundy, J.

AU - Dudek, G.

AU - Newton, R.

AU - Dugdale, A.

AU - Teague, W. G.

AU - Fitzpatrick, A.

AU - Khatri, S.

AU - Patel, R.

AU - Peabody, J.

AU - Hunter, E.

AU - Whitlock, D.

AU - Smith, L.

AU - Moy, J.

AU - Naureckas, E.

AU - Olopade, C. S.

AU - Hixon, J.

AU - Brees, A.

AU - Rivera, G.

AU - Sietsema, S.

AU - Zagaja, V.

AU - Busk, M.

AU - Williams, C.

AU - Puntenney, P.

AU - Busk, N.

AU - Leone, F.

AU - Hayes-Hampton, M.

AU - Summer, W. R.

AU - Meyaski, G.

AU - Wenzel, S.

AU - Calhoun, William

PY - 2009/4/9

Y1 - 2009/4/9

N2 - BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.)

AB - BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.)

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