Investigation of Intravenous (IV) Administration of an Approved Drug (MK0476, Montelukast Sodium) for Acute Asthma
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: MK0476, montelukast sodium / Duration of Treatment: 1 dose (Drug); Comparator: placebo / Duration of Treatment: 1 dose (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
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.
Clinical Details
Official title: A Multicenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Patients With Acute Asthma
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Improvement in forced expiratory volume in 1 second [FEV1] within the first 60 minutes after administration
Secondary outcome: Incidence of treatment failures, amount of additional therapy[short-acting B-agonist] required, rate of FEV1 improvement, safety and tolerability
Eligibility
Minimum age: 15 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Individuals with acute asthma
Exclusion Criteria:
- Women of child bearing age
- History of Chronic Obstructive Pulmonary Disease (COPD)
Locations and Contacts
Additional Information
Starting date: July 2004
Last updated: March 16, 2007
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