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

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

montelukast sodium

Drug

Montelukast 7 mg single injection (IV bolus administration) over 2-3 minutes

Other names: MK-0476

aminophylline hydrate

Drug

Aminophylline 250 mg IV drip infusion over 60 minutes

Other names: Kyophyllin® Injection 2.5%, FK05

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Mar 1, 2007
Registry last updated: Feb 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed