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Study to evaluate the bronchodilator effects of Zyflo CR in patients with chronic stable asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zileuton extended release | Other | Oral, 1200 mg (2 x 600 mg tablets) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zileuton extended release | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FEV1 | 12 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) | 72 Hours | |
| Number of Subjects With Adverse Events | 72 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeast Medical Research Associates | North Dartmouth | Massachusetts | 02747 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zileuton Extended Release | Zileuton extended release 1200 mg (2 x 600 mg tablets) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zileuton Extended Release | Zileuton extended release |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in FEV1 | Posted | Mean | Standard Deviation | Liter | 12 Hours |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zileuton Extended Release | Zileuton extended release |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal Liver Function | Hepatobiliary disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| W. James Alexander, MD, MPH | Cornerstone Therapeutics, Inc. | 919-678-6925 | jim.alexander@chiesi.com |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Area Under the Curve (AUC) | Not Posted | 72 Hours |
| Secondary | Number of Subjects With Adverse Events | Not Posted | 72 Hours |
| 0 |
| 25 |
| 3 |
| 25 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |