Trials / Completed
CompletedNCT00534625
Assessment of PFT, Safety, and PK of Zileuton Injection in Asthma Patients
Phase 2 Study of the Assessment of Pulmonary Function, Safety, Tolerability, and PK of Zileuton Injection in Patients With Chronic Stable Asthma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Critical Therapeutics · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | zileuton | Single injection of zileuton 150 mg |
| DRUG | placebo | Single injection of placebo |
| DRUG | zileuton | Single injection of zileuton 300 mg |
Timeline
- Start date
- 2007-09-01
- Primary completion
- 2008-03-01
- Completion
- 2008-03-01
- First posted
- 2007-09-26
- Last updated
- 2008-03-21
Source: ClinicalTrials.gov record NCT00534625. Inclusion in this directory is not an endorsement.