Study of MK0476 in Adult Patients With Acute Asthma (0476-334)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00442338
First received: February 27, 2007
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Asthma
Drug: montelukast
Drug: Comparator: Aminophylline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MK0476 Phase III Open Label Exploratory Comparative Clinical Study -Acute Exacerbations of Asthma -

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]
    The Average of Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at 60 minutes after drug administration


Enrollment: 91
Study Start Date: February 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Montelukast 7 mg
Montelukast
Drug: montelukast
Montelukast single injection of either 7 mg or 14 mg Intravenous Administration
Other Names:
  • MK0476
  • SINGULAIR ®
Experimental: Montelukast 14 mg
Montelukast
Drug: montelukast
Montelukast single injection of either 7 mg or 14 mg Intravenous Administration
Other Names:
  • MK0476
  • SINGULAIR ®
Active Comparator: Aminophylline 250 mg Drug: Comparator: Aminophylline
Single injection Aminophylline 250 mg Intravenous Drip Infusion

  Eligibility

Ages Eligible for Study:   15 Years to 75 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442338

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00442338     History of Changes
Other Study ID Numbers: 0476-334, MK0476-334, 2007_007
Study First Received: February 27, 2007
Results First Received: May 22, 2009
Last Updated: May 27, 2014
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
Aminophylline
Montelukast
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Protective Agents
Leukotriene Antagonists

ClinicalTrials.gov processed this record on July 22, 2014