Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00442338 | Study of MK-0476 in Adult Patients With Acute Asthma (0476-334) | PHASE3 | COMPLETED | 91 | — | — | Mar 1, 2007 | Aug 1, 2007 | Feb 2, 2022 | - | — |
The time weighted average change from Baseline in Forced Expiratory Volume in One Second (FEV1) over the first 60 minutes after study drug administration (average change FEV1 (0-60 min)). Baseline (pre-allocation) was the last measurement obtained during the screening period.
| Arm | Type | Description |
|---|---|---|
| Montelukast 7 mg | EXPERIMENTAL | Montelukast 7 mg IV administration |
| Montelukast 14 mg | EXPERIMENTAL | Montelukast 14 mg IV administration |
| Aminophylline 250 mg | ACTIVE_COMPARATOR | Aminophylline 250 mg IV drip administration |
| Name | Type | Description |
|---|---|---|
| montelukast sodium | DRUG | Montelukast 7 mg single injection (IV bolus administration) over 2-3 minutes |
| aminophylline hydrate | DRUG | Aminophylline 250 mg IV drip infusion over 60 minutes |
Inclusion Criteria: * Adult participants with acute asthma attacks Exclusion Criteria: * Participant has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., COPD, chronic heart failure, etc.). * Participant has a smoking habit (15 cigarettes per da...