Investigation of Intravenous (IV) Administration of an Approved Drug (MK-0476, Montelukast Sodium) for Acute Asthma (MK-0476-288)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: montelukast sodium (Drug); placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
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 (MK-0476, montelukast sodium) 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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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 9, 2015
|