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:	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:

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 ]
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: MK0476 SINGULAIR ®
Experimental: Montelukast 14 mg Montelukast	Drug: montelukast Montelukast single injection of either 7 mg or 14 mg Intravenous Administration Other Names: MK0476 SINGULAIR ®
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

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:	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 February 09, 2012