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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00092989
First received: September 28, 2004
Last updated: January 21, 2010
Last verified: January 2010
History of Changes
  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 3

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

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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:
    Drug: montelukast sodium
    Duration of Treatment: 1 dose
    Other Names:
    • MK0476
    • montelukast
    Drug: Comparator: placebo
    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

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00092989     History of Changes
Other Study ID Numbers: 2004_027, MK0476-288
Study First Received: September 28, 2004
Last Updated: January 21, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013