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

A Multicenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Patients With Acute Asthma

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092989

Enrollment

650

Registered

2004-09-29

Start date

2004-07-31

Completion date

2007-03-31

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief 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.

Interventions

DRUGmontelukast sodium

Duration of Treatment: 1 dose

DRUGplacebo

Duration of Treatment: 1 dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

Inclusion criteria

* Individuals with acute asthma

Exclusion criteria

* Women of child bearing age * History of Chronic Obstructive Pulmonary Disease (COPD)

Design outcomes

Primary

Measure	Time frame
Improvement in forced expiratory volume in 1 second [FEV1] within the first 60 minutes after administration	within the first 60 minutes after administration

Secondary

Measure	Time frame
Incidence of treatment failures, amount of additional therapy[short-acting B-agonist] required, rate of FEV1 improvement, safety and tolerability	Duration of trial

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026