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

Organon and Co650 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

650

Conditions

Asthma

Interventions

montelukast sodiumDRUG

Duration of Treatment: 1 dose

placeboDRUG

Duration of Treatment: 1 dose

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Individuals with acute asthma Exclusion Criteria: * Women of child bearing age * History of Chronic Obstructive Pulmonary Disease (COPD)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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