Study of MK0476 in Adult Patients With Acute Asthma - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00442338

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	MK0476 Phase III Open Label Exploratory Comparative Clinical Study -Acute Exacerbations of Asthma -

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast Aminophylline

U.S. FDA Resources

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 ]

Enrollment:	91
Study Start Date:	February 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Montelukast 7 mg: Experimental Montelukast	Drug: montelukast Montelukast single injection of either 7 mg or 14 mg Intravenous Administration
Montelukast 14 mg: Experimental Montelukast	Drug: montelukast Montelukast single injection of either 7 mg or 14 mg Intravenous Administration
Aminophylline 250 mg: Active Comparator	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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442338

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_007, MK0476-334
Study First Received:	February 27, 2007
Results First Received:	May 22, 2009
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00442338 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Respiratory System Agents
Bronchial Diseases
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses
Aminophylline
Immune System Diseases

Asthma
Anti-Asthmatic Agents
Enzyme Inhibitors
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Montelukast
Phosphodiesterase Inhibitors
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 09, 2009