This article is more than 5 years old. Information may no longer be current.

Levalbuterol brings greater lung function gains in children not taking steroids

ORLANDO, Fla. — Levalbuterol was responsible for greater gains in lung function among children not already taking steroids, according to data presented here during the American Academy of Allergy, Asthma & Immunology 2012 Annual Meeting.

In a post-hoc analysis, researchers observed the opposite result in patients treated with racemic albuterol (RAC).

The study analyzed data from a 4-week, multicenter, double-blind, randomized, efficacy and safety trial with a primary endpoint of peak percent change in forced expiratory volume in 1 second (FEV₁) rates from pre-dose averaged over the double-blind period (DBAv perecent change in FEV₁).

Patients between the ages of 4 and 11 years with stable asthma for more than 6 months and 45% to 80% predicted FEV₁ were randomized to receive levalbuterol (LEV). A total of 42 steroid users and 34 non-steroid users were given 90 mcg four times daily. A total of 19 steroid users and 20 non-steroid users were given RAC 180 mcg four times daily. A total of 13 steroid users and 22 non-steroid users were given placebo.

DBAv % change FEV₁ was 29.4% and 19.6% for non-steroid users and 23.7% and 13.2% for steroid users in the LEV and placebo groups, respectively. Non-steroid users treated with RAC had a 16.7% DBAv % change FEV₁ and steroid users had a 26.4% change. Area under the curve FEV₁ percent change followed a similar trend as DBAv percent change in FEV₁.

Responses rates (peak percent change in FEV₁ of more than 15%) averaged over the double-blind period were:

Steroid users

• LEV: 85.7%,
• RAC: 94.7%
• Placebo: 23%

Non- Steroid users

• LEV: 93.7%
• RAC: 47.4%
• Placebo: 50%

For more information:

• Walsh J. #288. Post-hoc Analysis Of Short-acting Beta2-agonist Efficacy In Baseline Corticosteroid Users And Non-corticosteroid Users Following Treatment With Levalbuterol Metered-dose Inhaler, Racemic Albuterol Or Placebo In Asthma Patients Ages 4-11 Years. Presented at: the 2012 AAAAI Annual Meeting; March 2-6, 2012; Orlando, Fla.