Investigation of Intravenous (IV) Administration of an Approved Drug (MK0476, Montelukast Sodium) for Acute Asthma (0476-288)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092989
First received: September 28, 2004
Last updated: May 9, 2014
Last verified: May 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092989     History of Changes
Other Study ID Numbers: 0476-288, MK0476-288, 2004_027
Study First Received: September 28, 2004
Last Updated: May 9, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014