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

January 31, 2022 updated by: Organon and Co

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

650

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals with acute asthma

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
within the first 60 minutes after administration

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Duration of trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

September 28, 2004

First Submitted That Met QC Criteria

September 28, 2004

First Posted (Estimate)

September 29, 2004

Study Record Updates

Last Update Posted (Actual)

February 14, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0476-288
  • MK-0476-288 (Other Identifier: Merck Protocol Number)
  • 2004_027 (Other Identifier: Merck Registration Number)

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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