MK0476 Study in Adult Patients With Acute Asthma - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00229970

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: montelukast sodium Drug: Comparator: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	MK0476 Phase II/III Placebo Controlled Double Blind Study

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1) [ Time Frame: baseline over the first 60 minutes ] [ Designated as safety issue: No ]
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

Enrollment:	225
Study Start Date:	September 2005
Study Completion Date:	June 2007
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Placebo	Drug: Comparator: Placebo Placebo single injection
Experimental: 2 MK0476 7 mg injection	Drug: montelukast sodium 7 mg or 14 mg single injection
Experimental: 3 MK0476 14 mg injection	Drug: montelukast sodium 7 mg or 14 mg single injection

Eligibility

Ages Eligible for Study:	15 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229970

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00229970 History of Changes
Other Study ID Numbers:	2005_084, MK0476-322
Study First Received:	September 28, 2005
Results First Received:	May 22, 2009
Last Updated:	April 14, 2010
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

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

Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012