Investigation of Intravenous (IV) Administration of an Approved Drug (MK0476, Montelukast Sodium) for Acute Asthma - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092989

Purpose

The purpose of this study is to evaluate improved results of treatment for patients entering an emergency department with asthma attacks when given an investigational IV administration of an approved drug in addition to approved standard treatment.

Condition	Intervention	Phase
Asthma	Drug: montelukast sodium Drug: Comparator: placebo	Phase III

MedlinePlus related topics: Asthma Dietary Sodium

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Patients With Acute Asthma

Further study details as provided by Merck:

Primary Outcome Measures:

Improvement in forced expiratory volume in 1 second [FEV1] within the first 60 minutes after administration [ Time Frame: within the first 60 minutes after administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of treatment failures, amount of additional therapy[short-acting B-agonist] required, rate of FEV1 improvement, safety and tolerability [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]

Enrollment:	650
Study Start Date:	July 2004
Study Completion Date:	May 2007

Intervention Details:

Duration of Treatment: 1 dose

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Individuals with acute asthma

Exclusion Criteria:

Women of child bearing age
History of Chronic Obstructive Pulmonary Disease (COPD)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092989

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2004_027, MK0476-288
Study First Received:	September 28, 2004
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00092989
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Montelukast
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Leukotriene Antagonists
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Immune System Diseases
Bronchial Diseases
Therapeutic Uses
Hormone Antagonists

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009