Trial | NCT01805687  Report issue

Title

Single Dose Bronchodilatory Study in Asthma
A Single-Center, Open-Label, Single-Dose Evaluation of the Duration and Extent of Bronchodilation Following Administration of Zileuton CR 1200 mg in Subjects With Stable, Chronic Asthma

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Intervention/Treatment

    zileuton ...

  • Study Participants

    25
Study to evaluate the bronchodilator effects of Zyflo CR in patients with chronic stable asthma.
Study Started
Mar 31
2013
Primary Completion
Jun 30
2013
Results Posted
Aug 18
2014
Estimate
Last Update
Sep 03
2014
Estimate

Drug Zileuton extended release

Zileuton extended release Other

Oral, 1200 mg (2 x 600 mg tablets)

Criteria 

Inclusion Criteria:

Diagnosis of asthma for at least 5 years
FEV1 of 50-85% predicted
Reversible airway obstruction

Exclusion Criteria:

Pregnant/nursing females
Liver function tests greater than upper limit of normal

Summary

Zileuton Extended Release

All Events

Event Type Organ System Event Term Zileuton Extended Release

Change From Baseline in FEV1

Zileuton Extended Release

2.84
Liter (Mean)
Standard Deviation: 0.706

Area Under the Curve (AUC)

Outcome Measure Data Not Reported

Number of Subjects With Adverse Events

Outcome Measure Data Not Reported

Age, Continuous

35
years (Mean)
Standard Deviation: 10.2

Sex: Female, Male

Overall Study

Zileuton Extended Release