Study of MK0476 in Adult Patients With Acute Asthma
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00442338
First received: February 27, 2007
Last updated: April 20, 2010
Last verified: April 2010
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Purpose
The study estimates the efficacy and safety of MK0476 and aminophylline intravenous administration in adult patients with acute asthma.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: montelukast Drug: Comparator: Aminophylline |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | MK0476 Phase III Open Label Exploratory Comparative Clinical Study -Acute Exacerbations of Asthma - |
Resource links provided by NLM:
Further study details as provided by Merck:
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
| Enrollment: | 91 |
| Study Start Date: | February 2007 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Montelukast 7 mg
Montelukast
|
Drug: montelukast
Montelukast single injection of either 7 mg or 14 mg Intravenous Administration
Other Names:
|
|
Experimental: Montelukast 14 mg
Montelukast
|
Drug: montelukast
Montelukast single injection of either 7 mg or 14 mg Intravenous Administration
Other Names:
|
| Active Comparator: Aminophylline 250 mg |
Drug: Comparator: Aminophylline
Single injection Aminophylline 250 mg Intravenous Drip Infusion
|
Eligibility| Ages Eligible for Study: | 15 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00442338 History of Changes |
| Other Study ID Numbers: | 2007_007, MK0476-334 |
| Study First Received: | February 27, 2007 |
| Results First Received: | May 22, 2009 |
| Last Updated: | April 20, 2010 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Aminophylline Montelukast Cardiotonic Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Protective Agents Leukotriene Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013