Inhaled lidocaine for the treatment of asthma: lack of efficacy in two double-blind, randomized, placebo-controlled clinical studies.
BACKGROUND
Asthma with severe or persistent exacerbations is treated with chronic oral corticosteroids (OCS), such as prednisone. Although efficacious, OCS treatment is often associated with side effects; thus, corticosteroid-sparing treatments are needed.


METHODS
We conducted two double-blind, placebo-controlled, clinical studies assessing lidocaine solution for inhalation (LSI; 40 mg twice daily; eFlow(®) nebulizer) to treat asthma. Study 1-Mild/Moderate included 154 patients with mild-moderate asthma [forced expiratory volume in one second (FEV(1)) ≥60% predicted, and ≥12% improvement in FEV(1) (L) after short-acting, inhaled β-agonist; no OCS or inhaled corticosteroids (ICS) in previous month] and evaluated whether FEV(1) improved after 12 weeks of treatment. Study 2-OCS included 114 patients with more severe asthma (FEV(1) 35-85% of predicted values, treatment with OCS for ≥6 months, average daily dose between 5 and 70 mg prednisone or equivalent, stable ≥30 days) and evaluated whether 20 weeks of treatment had a corticosteroid-sparing effect, measured as reduced need for OCS.


RESULTS
LSI did not improve pulmonary function in Study 1-Mild/Moderate, and did not have a corticosteroid-sparing effect in Study 2-OCS, when compared with placebo. Thus, the primary efficacy endpoints were not met. Significant improvements were not observed for asthma symptom scores, morning and evening peak expiratory flow values, FEV(1) % predicted, proportion of patients with asthma instability, and asthma quality-of-life scores at week 12 (Study 1-Mild/Moderate) or week 20 (Study 2-OCS). LSI was well tolerated.


CONCLUSIONS
These results indicate that lidocaine solution for inhalation is not a useful treatment for asthma; it did not improve pulmonary function and did not have a corticosteroid-sparing effect.
Gilead Sciences Inc., Seattle, Washington 98102, USA.
Tammy
T
Abuan
Melissa
M
Yeager
A Bruce
AB
Montgomery
D000280:Administration, Inhalation; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008012:Lidocaine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D012129:Respiratory Function Tests; D017211:Treatment Failure
D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents; D008012:Lidocaine