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

Organon and Co91 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

montelukast sodiumDRUG

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

montelukast sodiumDRUG

Montelukast 14 mg single injection (IV bolus administration) over 5 minutes

aminophylline hydrateDRUG

Aminophylline 250 mg IV drip infusion over 60 minutes

Eligibility

Sex: ALLMin age: 15 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After 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.

Time frame: Baseline and 60 minutes after study drug administration

Data from ClinicalTrials.gov

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