The mean time to onset of a 15% increase in FEV₁ over baseline for levalbuterol at doses of 0.63 mg and 1.25 mg was approximately 17 minutes and10 minutes, respectively, and the mean time to peak effect for both doses was approximately 1.5 hours after 4 weeks of treatment. The mean duration ofeffect, as measured by a > 15% increase from baseline FEV₁, was approximately 5 hours after administration of 0.63 mg of levalbuterol and approximately6 hours after administration of 1.25 mg of levalbuterol after 4 weeks of treatment. In some patients, the duration of effect was as long as 8 hours.

Clinical Trials (Children 6-11 years old)

A multi-center, randomized, double-blind, placebo- and active-controlled study was conducted in children with mild-to-moderate asthma (mean baseline FEV₁ 73% of predicted) (n=316). Following a 1-week placebo run-in, subjects were randomized to Xopenex (0.31 or 0.63 mg), racemic albuterol(1.25 or 2.5 mg), or placebo, which were delivered three times a day for 3-weeks using a PARI LC Plus™ nebulizer and a Dura-Neb® 3000 compressor.

Efficacy, as measured by mean peak percent change from baseline FEV₁, was demonstrated for all active treatment regimens compared with placebo onday 1 and day 21. Time profile FEV₁ curves for day 1 and day 21 are shown in Figure 3 and Figure 4, respectively. The onset of effect (time to a 15%increase in FEV₁ over test-day baseline) and duration of effect (maintenance of a > 15% increase in FEV₁ over test-day baseline) of levalbuterol were clinically comparable to those of racemic albuterol.

Figure 3: Mean Percent Change from Baseline FEV₁ on Day 1, Children 6-11 Years of Age

Figure 4: Mean Percent Change from Baseline FEV₁ on Day 21, Children 6-11 Years of Age

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