BACKGROUND: Difficult-to-control asthma has been associated with gastroesophageal acid reflux. Acid-suppressive treatment has been inconsistent in improving asthma control. OBJECTIVE: To determine whether a proton-pump inhibitor improves asthma control in adult asthmatic patients with acid reflux symptoms. DESIGN: Multicenter, double-blind, randomized, placebo-controlled trial. SETTING:Twenty-nine private practices and 3 academic practices in the United States. PATIENTS: Two hundred seven patients receiving usual asthma care including an inhaled corticosteroid (ICS). Patients had acid reflux symptoms and moderate-to-severe persistent asthma. INTERVENTION: Lansoprazole, 30 mg bid, or placebo, bid, for 24 weeks. MEASUREMENTS: The primary outcome measure was daily asthma symptoms by diary. Secondary asthma outcomes included rescue albuterol use, daily morning and evening peak expiratory flow, FEV1, FVC, asthma quality of life with standardized activities (AQLQS) questionnaire score, investigator-assessed symptoms, exacerbations, and oral corticosteroid-treated exacerbations. RESULTS:Daily asthma symptoms, albuterol use, peak expiratory flow, FEV1, FVC, and investigator-assessed asthma symptoms at 24 weeks did not improve significantly with lansoprazole treatment compared to placebo. The AQLQS emotional function domain improved at 24 weeks (p = 0.025) with lansoprazole therapy. Fewer patients receiving lansoprazole (8.1% vs 20.4%, respectively; p = 0.017) had exacerbations and oral corticosteroid-treated (ie, moderate-to-severe) exacerbations (4% vs 13.9%, respectively; p = 0.016) of asthma. A post hoc subgroup analysis revealed that fewer patients receiving one or more long-term asthma-control medications in addition to an ICS experienced exacerbations (6.5% vs 24.6%, respectively; p = 0.016) and moderate-to-severe exacerbations (2.2% vs 17.5%, respectively; p = 0.021) with lansoprazole therapy. CONCLUSION: In adult patients with moderate-to-severe persistent asthma and symptoms of acid reflux, treatment with 30 mg oflansoprazole bid for 24 weeks did not improve asthma symptoms or pulmonary function, or reduce albuterol use. However, this dose significantly reduced asthma exacerbations and improved asthma quality of life, particularly in those patients receiving more than one asthma-control medication.
RCT Entities:
BACKGROUND: Difficult-to-control asthma has been associated with gastroesophageal acid reflux. Acid-suppressive treatment has been inconsistent in improving asthma control. OBJECTIVE: To determine whether a proton-pump inhibitor improves asthma control in adult asthmatic patients with acid reflux symptoms. DESIGN: Multicenter, double-blind, randomized, placebo-controlled trial. SETTING: Twenty-nine private practices and 3 academic practices in the United States. PATIENTS: Two hundred seven patients receiving usual asthma care including an inhaled corticosteroid (ICS). Patients had acid reflux symptoms and moderate-to-severe persistent asthma. INTERVENTION: Lansoprazole, 30 mg bid, or placebo, bid, for 24 weeks. MEASUREMENTS: The primary outcome measure was daily asthma symptoms by diary. Secondary asthma outcomes included rescue albuterol use, daily morning and evening peak expiratory flow, FEV1, FVC, asthma quality of life with standardized activities (AQLQS) questionnaire score, investigator-assessed symptoms, exacerbations, and oral corticosteroid-treated exacerbations. RESULTS: Daily asthma symptoms, albuterol use, peak expiratory flow, FEV1, FVC, and investigator-assessed asthma symptoms at 24 weeks did not improve significantly with lansoprazole treatment compared to placebo. The AQLQS emotional function domain improved at 24 weeks (p = 0.025) with lansoprazole therapy. Fewer patients receiving lansoprazole (8.1% vs 20.4%, respectively; p = 0.017) had exacerbations and oral corticosteroid-treated (ie, moderate-to-severe) exacerbations (4% vs 13.9%, respectively; p = 0.016) of asthma. A post hoc subgroup analysis revealed that fewer patients receiving one or more long-term asthma-control medications in addition to an ICS experienced exacerbations (6.5% vs 24.6%, respectively; p = 0.016) and moderate-to-severe exacerbations (2.2% vs 17.5%, respectively; p = 0.021) with lansoprazole therapy. CONCLUSION: In adult patients with moderate-to-severe persistent asthma and symptoms of acid reflux, treatment with 30 mg of lansoprazolebid for 24 weeks did not improve asthma symptoms or pulmonary function, or reduce albuterol use. However, this dose significantly reduced asthma exacerbations and improved asthma quality of life, particularly in those patients receiving more than one asthma-control medication.
Authors: John G Mastronarde; Nicholas R Anthonisen; Mario Castro; Janet T Holbrook; Frank T Leone; W Gerald Teague; Robert A Wise Journal: N Engl J Med Date: 2009-04-09 Impact factor: 91.245