Study of MK0476 in Adult Patients With Acute Asthma (0476-334)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: February 27, 2007
Last updated: May 11, 2015
Last verified: May 2015
The study estimates the efficacy and safety of MK0476 and aminophylline intravenous administration in adult patients with acute asthma.

Condition Intervention Phase
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 Sharp & Dohme Corp.:

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: March 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
Drug: montelukast
Montelukast single injection of either 7 mg or 14 mg Intravenous Administration
Other Names:
  • MK0476
Experimental: Montelukast 14 mg
Drug: montelukast
Montelukast single injection of either 7 mg or 14 mg Intravenous Administration
Other Names:
  • MK0476
Active Comparator: Aminophylline 250 mg Drug: Comparator: Aminophylline
Single injection Aminophylline 250 mg Intravenous Drip Infusion


Ages Eligible for Study:   15 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00442338

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00442338     History of Changes
Other Study ID Numbers: 0476-334  MK0476-334  2007_007 
Study First Received: February 27, 2007
Results First Received: May 22, 2009
Last Updated: May 11, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiotonic Agents
Cardiovascular Agents
Enzyme Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Protective Agents
Purinergic Agents
Purinergic Antagonists
Purinergic P1 Receptor Antagonists processed this record on May 04, 2016