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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Experimental | 150 mg zileuton by intravenous injection |
|
| 3 | Experimental | 300 mg zileuton by intravenous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zileuton | Drug | Single injection of zileuton 150 mg |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on pulmonary function | Within 0-12 hours after single dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessments | Within 0-36 hours after single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Cees Wortel | Critical Therapeutics | Study Director |
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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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| ID | Term |
|---|---|
| C063449 | zileuton |
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| Drug |
Single injection of placebo |
|
| zileuton | Drug | Single injection of zileuton 300 mg |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |