Effects of 24 weeks of lansoprazole therapy on asthma symptoms, exacerbations, quality of life, and pulmonary function in adult asthmatic patients with acid reflux symptoms.
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.


METHODS
Multicenter, double-blind, randomized, placebo-controlled trial.


METHODS
Twenty-nine private practices and 3 academic practices in the United States.


METHODS
Two hundred seven patients receiving usual asthma care including an inhaled corticosteroid (ICS). Patients had acid reflux symptoms and moderate-to-severe persistent asthma.


METHODS
Lansoprazole, 30 mg bid, or placebo, bid, for 24 weeks.


METHODS
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.


CONCLUSIONS
In adult patients with moderate-to-severe persistent asthma and symptoms of acid reflux, treatment with 30 mg of lansoprazole 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.
Littner
Michael R
MR
Department of Medicine, Veterans Affairs Greater Los Angeles Healthcare System, Sepulveda, CA 91343, USA. mlittner@ucla.edu
Leung
Felix W
FW
Ballard
E David
ED
Huang
Bidan
B
Samra
Nina K
NK
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000280:Administration, Inhalation; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage; D000328:Adult; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage; D001249:Asthma / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000031:analogs & derivatives* / Q000627:therapeutic use; D054328:Proton Pump Inhibitors; D011788:Quality of Life; D012008:Recurrence; D012129:Respiratory Function Tests
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents; D004791:Enzyme Inhibitors; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D009853:Omeprazole