Study of MK-0476 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: June 9, 2016
Last verified: June 2016
  Purpose
The study estimates the efficacy and safety of MK0476 and aminophylline intravenous administration in adult participants with acute asthma.

Condition Intervention Phase
Asthma
Drug: montelukast sodium
Drug: aminophylline hydrate
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: MK-476 IV Formulation Phase III Open Label Exploratory Comparative Study - Acute Exacerbations of Asthma -

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration [ Time Frame: Baseline and 60 minutes after study drug administration ] [ Designated as safety issue: No ]
    The time weighted average change from Baseline in Forced Expiratory Volume in One Second (FEV1) over the first 60 minutes after study drug administration (average change FEV1 (0-60 min)). Baseline (pre-allocation) was the last measurement obtained during the screening period.


Enrollment: 91
Study Start Date: March 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 7 mg IV administration
Drug: montelukast sodium
Montelukast 7 mg single injection (IV bolus administration) over 2-3 minutes
Other Name: MK-0476
Experimental: Montelukast 14 mg
Montelukast 14 mg IV administration
Drug: montelukast sodium
Montelukast 14 mg single injection (IV bolus administration) over 5 minutes
Other Name: MK-0476
Active Comparator: Aminophylline 250 mg
Aminophylline 250 mg IV drip administration
Drug: aminophylline hydrate
Aminophylline 250 mg IV drip infusion over 60 minutes
Other Name: Kyophyllin® Injection 2.5%, FK05

  Eligibility

Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult participants with acute asthma attacks

Exclusion Criteria:

  • Participant has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., COPD, chronic heart failure, etc.).
  • Participant 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.
  • Participant 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 Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00442338     History of Changes
Other Study ID Numbers: 0476-334  MK-0476-334  2007_007 
Study First Received: February 27, 2007
Results First Received: May 22, 2009
Last Updated: June 9, 2016
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
Aminophylline
Theophylline
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
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents

ClinicalTrials.gov processed this record on July 28, 2016