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

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ClinicalTrials.gov Identifier: NCT00229970
Recruitment Status : Completed
First Posted : September 30, 2005
Results First Posted : July 17, 2009
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Asthma Drug: montelukast sodium Drug: Comparator: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: MK0476 Phase II/III Placebo Controlled Double Blind Study
Study Start Date : September 2005
Actual Primary Completion Date : October 2006
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00229970


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00229970     History of Changes
Other Study ID Numbers: 0476-322
MK0476-322
2005_084
First Posted: September 30, 2005    Key Record Dates
Results First Posted: July 17, 2009
Last Update Posted: May 21, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action