CRITICAL THERAPEUTICS COMPLETES TRIAL OF ZILEUTON FOR ASTHMA
Critical Therapeutics announced that it has completed the double-blind, placebo-controlled, single-dose Phase I/II clinical trial of the intravenous formulation of zileuton in patients with asthma. The company is developing zileuton initially for use in patients who suffer acute exacerbations of asthma.
The trial was designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy in 60 patients. Patients dosed in the study had a baseline lung function of 40 to 80 percent of predicted normal, as measured by forced expiratory volume.
Patients enrolled in the study were randomized into four escalating-dose groups, each receiving one infusion of either zileuton or placebo. Lung function measurements were taken prior to dosing and at additional times during the 24-hour period after the infusion. All patients participated in a three-day follow-up period, primarily to assess the safety of the drug.