Asthma
Conditions
Brief summary
Study to evaluate the bronchodilator effects of Zyflo CR in patients with chronic stable asthma.
Interventions
DRUGZileuton extended release
Sponsors
Cornerstone Therapeutics Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in FEV1 | 12 Hours |
Secondary
| Measure | Time frame |
|---|---|
| Area Under the Curve (AUC) | 72 Hours |
| Number of Subjects With Adverse Events | 72 Hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zileuton Extended Release Zileuton extended release | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Zileuton Extended Release |
|---|---|
| Age, Continuous | 35 years STANDARD_DEVIATION 10.2 |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Change From Baseline in FEV1
Time frame: 12 Hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zileuton Extended Release | Change From Baseline in FEV1 | 2.84 Liter | Standard Deviation 0.706 |
Secondary
Area Under the Curve (AUC)
Time frame: 72 Hours
Secondary
Number of Subjects With Adverse Events
Time frame: 72 Hours