drugset / Trial / NCT00534625

Assessment of PFT, Safety, and PK of Zileuton Injection in Asthma Patients

NCT00534625

Phase 2 Completed 36 enrolled Critical Therapeutics
RandomizedCrossoverQuadruple-blindTreatment

Summary

A single intravenous injection of zileuton (150 or 300 mg) will be administered to patients with stable asthma. The goals will be to determine if zileuton i.v. can produce a rapid increase in FEV1/PEFR and when this effect can be seen. The safety of this route of administration of zileuton will also be studied. PK will be obtained in a population based method.

Timeline

Start
2007-09
Primary completion
2008-03
Completion
2008-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Zileuton Small molecule 150 mg Intravenous
Subject Zileuton Small molecule 300 mg Intravenous

Indications