[Figure 1 (not shown) shows the mean effect of ZYFLO versus placebo for the primary efficacy variable, trough FEV₁, over the course of Study 1.]

Of all the patients in Study 1 and Study 2, 7.0% of those administered ZYFLO 600 mg four times daily required systemic corticosteroid therapy for exacerbation of asthma, whereas 18.7% of the placebo group required corticosteroid treatment. This difference was statistically significant.

In these trials, there was a statistically significant improvement from baseline in FEV₁, which occurred 2 hours after initial administration of ZYFLO. This mean increase was approximately 0.10 L greater than that in placebo-treated patients.

These studies evaluated patients receiving as-needed inhaled beta-agonist as their only asthma therapy. In this patient population, post-hoc analyses suggested that individuals with lower FEV₁ values at baseline showed a greater improvement.

The role of ZYFLO in the management of patients with more severe asthma, patients receiving anti-asthma therapy other than as-needed, inhaled beta-agonists, or patients receiving it as an oral or inhaled corticosteroid-sparing agent remains to be fully characterized.

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