Study of MK-0476 in Adult Patients With Acute Asthma (0476-334)

January 31, 2022 updated by: Organon and Co

MK-476 IV Formulation Phase III Open Label Exploratory Comparative Study - Acute Exacerbations of Asthma -

The study estimates the efficacy and safety of MK0476 and aminophylline intravenous administration in adult participants with acute asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

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 to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult participants with acute asthma attacks

Exclusion Criteria:

  • Participant has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., COPD, chronic heart failure, etc.).
  • Participant has a smoking habit (15 cigarettes per day) within a month prior to screening period, and/or has a smoking history (20 cigarettes per day) of more than 15 years.
  • Participant has a disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe disease.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Montelukast 7 mg
Montelukast 7 mg IV administration
Drug: montelukast sodium
Montelukast 7 mg single injection (IV bolus administration) over 2-3 minutes
Other Names:
  • MK-0476
Drug: montelukast sodium
Montelukast 14 mg single injection (IV bolus administration) over 5 minutes
Other Names:
  • MK-0476
Experimental: Montelukast 14 mg
Montelukast 14 mg IV administration
Drug: montelukast sodium
Montelukast 7 mg single injection (IV bolus administration) over 2-3 minutes
Other Names:
  • MK-0476
Drug: montelukast sodium
Montelukast 14 mg single injection (IV bolus administration) over 5 minutes
Other Names:
  • MK-0476
Active Comparator: Aminophylline 250 mg
Aminophylline 250 mg IV drip administration
Drug: aminophylline hydrate
Aminophylline 250 mg IV drip infusion over 60 minutes
Other Names:
  • Kyophyllin® Injection 2.5%, FK05

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration
Time Frame: Baseline and 60 minutes after study drug administration
The time weighted average change from Baseline in Forced Expiratory Volume in One Second (FEV1) over the first 60 minutes after study drug administration (average change FEV1 (0-60 min)). Baseline (pre-allocation) was the last measurement obtained during the screening period.
Baseline and 60 minutes after study drug administration

Collaborators and Investigators

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

Sponsor

Organon and Co

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

March 1, 2007

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

February 27, 2007

First Submitted That Met QC Criteria

February 27, 2007

First Posted (Estimate)

March 1, 2007

Study Record Updates

Last Update Posted (Actual)

February 2, 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

  • 0476-334
  • MK-0476-334
  • 2007_007

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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