Study of MK0476 in Adult Patients With Acute Asthma
Overview[ - collapse ][ - ]
| Purpose | The study estimates the efficacy and safety of MK0476 and aminophylline intravenous administration in adult patients with acute asthma. |
|---|---|
| Condition | Asthma |
| Intervention | Drug: montelukast Drug: Comparator: Aminophylline |
| Phase | Phase 3 |
| Sponsor | Merck Sharp & Dohme Corp. |
| Responsible Party | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier | NCT00442338 |
| First Received | February 27, 2007 |
| Last Updated | April 20, 2010 |
| Last verified | April 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | February 27, 2007 |
|---|---|
| Last Updated Date | April 20, 2010 |
| Start Date | February 2007 |
| Estimated Primary Completion Date | August 2007 |
| Current Primary Outcome Measures | Improvement in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration [Time Frame: 60 minutes after drug administration] [Designated as safety issue: No]The Average of Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at 60 minutes after drug administration |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Study of MK0476 in Adult Patients With Acute Asthma |
|---|---|
| Official Title | MK0476 Phase III Open Label Exploratory Comparative Clinical Study -Acute Exacerbations of Asthma - |
| Brief Summary | The study estimates the efficacy and safety of MK0476 and aminophylline intravenous administration in adult patients with acute asthma. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Asthma |
| Intervention | Drug: montelukast Montelukast single injection of either 7 mg or 14 mg Intravenous Administration Other Names:
Single injection Aminophylline 250 mg Intravenous Drip Infusion |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 91 |
| Estimated Completion Date | August 2007 |
| Estimated Primary Completion Date | August 2007 |
| Eligibility Criteria | Inclusion Criteria: - Adult patients with acute asthma attacks Exclusion Criteria: - Patient has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., copd, chronic heart failure, etc.). - Patient has a smoking habit (15 cigarettes per day) within a month prior to screening period, and/or has a smoking history (20 cigarettes per day) of more than 15 years. - Patient has a disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe disease. |
| Gender | Both |
| Ages | 15 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00442338 |
|---|---|
| Other Study ID Numbers | 2007_007 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Merck Sharp & Dohme Corp. |
| Study Sponsor | Merck Sharp & Dohme Corp. |
| Collaborators | Not Provided |
| Investigators | Study Director: Medical Monitor Merck Sharp & Dohme Corp. |
| Verification Date | April 2010 |