Treatment of asthma with nebulized lidocaine: A randomized, placebo-controlled study

Background: In 2 prior uncontrolled studies, nebulized lidocaine reduced oral glucocorticoid use in patients with severe glucocorticoid-dependent asthma. Objective: We tested the safety and efficacy of nebulized lidocaine in a randomized, placebo-controlled study in patients with mild-to-moderate asthma. Methods: We recruited 50 subjects (25 receiving lidocaine and 25 receiving placebo); all had a prebronchodilator FEV1 of 64% to 125% of predicted normal value and were treated with daily inhaled glucocorticoids (but not systemic glucocorticoids) and bronchodilators for at least 2 months. Before treatment, subjects monitored their symptoms and peak How values and maintained their medications for 2 weeks. At initiation, subjects inhaled either nebulized placebo (saline) or lidocaine (4%, 100 mg) 4 times daily. All subjects were instructed to reduce their inhaled glucocorticoid dosage by one half each week for 3 weeks and to discontinue glucocorticoid treatment at week 4. The subjects continued the nebulized lidocaine or placebo for a total of 8 weeks, monitored their symptoms, and used bronchodilators to control symptoms. Results: Indicators of asthma severity showed benefit for the lidocaine-treated group: changes in FEV1 (P less than or equal to .001), nighttime awakenings (P less than or equal to .02), symptoms (P less than or equal to .010), bronchodilator use (P less than or equal to .010), and blood eosinophil counts (P less than or equal to .020). Subjects in both groups reduced use of inhaled glucocorticoids comparably. Subjects receiving nebulized placebo showed increases in their symptom scores, bronchodilator use (P less than or equal to .05 for both), and blood eosinophil counts (P less than or equal to .01) and decreases in FEV1 (P less than or equal to .001). Conclusion: Nebulized lidocaine provided effective and safe therapy in subjects with mild-to-moderate asthma.