MK0476 Study in Adult Patients With Acute Asthma (0476-322)

This study evaluates the efficacy and safety of MK0476 intravenous administration in adult patients with acute asthma.

Completed

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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–65 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 Patients With Acute Asthma Attacks

Exclusion criteria

Patient Has Any Known Or Suspected, Acute Or Chronic Cause For Their Pulmonary Symptoms Other Than Asthma (E.G., Copd, Chronic Heart Failure, Etc.)
Patient Has A Smoking History (20 Cigarettes Per Day) Of More Than 15 Years
Patient Has A Disease Of The Cardiovascular, Hepatic, Renal, Hematologic Systems, Or Other Severe Disease

Treatment and study plan

montelukast sodium

Drug

7 mg or 14 mg single injection

Comparator: placebo

Drug

Placebo single injection

Primary outcomes

The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1)

Time frame: baseline over the first 60 minutes

The Time Weighed Average Changes in Forced Expiratory Volume in One Second (FEV1) from pre-allocation baseline over the first 60 minutes after study drug administration with time interval between any measurement and the measurement prior to it is used as the weighting factor

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

MK0476 Phase II/III Placebo Controlled Double Blind Study

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2007
First posted: Sep 30, 2005
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