Study of MK0476 in Adult Patients With Acute Asthma - Tabular View

Tracking Information

First Received Date ^ICMJE

February 27, 2007

Last Updated Date

November 6, 2009

Start Date ^ICMJE

February 2007

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Improvement in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration [ Time Frame: 60 minutes after drug administration ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Improvement in forced expiratory volume in one second (fev1) within the first 60 minutes after administration

Change History

Complete list of historical versions of study NCT00442338 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Study of MK0476 in Adult Patients With Acute Asthma

Official Title ^ICMJE

MK0476 Phase III Open Label Exploratory Comparative Clinical Study -Acute Exacerbations of Asthma -

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: montelukast
Drug: Comparator: Aminophylline

Study Arms / Comparison Groups

Experimental: Montelukast

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 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.
Patient has a disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe disease.

Gender

Both

Ages

15 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00442338

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2007_007, MK0476-334

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP