Investigation of Intravenous (IV) Administration of an Approved Drug (MK-0476, Montelukast Sodium) for Acute Asthma (MK-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: March 9, 2015
Last verified: March 2015
  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 (MK-0476, montelukast sodium) in addition to approved standard treatment.


Condition Intervention Phase
Asthma
Drug: montelukast sodium
Drug: 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: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Montelukast 7 mg
Participants receive montelukast 7 mg intravenously (IV) until until a decision is made for one of the following: (1) discontinuation from the study, (2) discharge from the study site, or (3) admission to the hospital. All randomized participants will receive systemic corticosteroids (60 mg prednisone OR 50 mg prednisolone) orally immediately after the completion of the study drug administration. In addition, all participants will continue to receive standardized treatment in addition to study drug. Standardized treatment may consist of: (1) β-agonist administration beginning 20 minutes after study drug infusion, and every 20 minutes thereafter, as needed; (2) oxygen therapy; and (3) inhaled ipratropium every 60 minutes as needed.
Drug: montelukast sodium
Duration of Treatment: 1 dose
Other Names:
  • MK-0476
  • montelukast
Placebo Comparator: Placebo
Participants receive placebo IV until until a decision is made for one of the following: (1) discontinuation from the study, (2) discharge from the study site, or (3) admission to the hospital. All randomized participants will receive systemic corticosteroids (60 mg prednisone OR 50 mg prednisolone) orally immediately after the completion of the study drug administration. In addition, all participants will continue to receive standardized treatment in addition to study drug. Standardized treatment may consist of: (1) β-agonist administration beginning 20 minutes after study drug infusion, and every 20 minutes thereafter, as needed; (2) oxygen therapy; and (3) inhaled ipratropium every 60 minutes as needed.
Drug: 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, MK-0476-288, 2004_027
Study First Received: September 28, 2004
Last Updated: March 9, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
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 March 26, 2015