A Study to Compare Effectiveness of Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics

This study has been completed.

First Received: September 7, 2005 Last Updated: February 2, 2007 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00157937

Purpose

Subjects have 8-week with montelukast sodium or comparator drug administration period, 2-week wash-out period and 8-week comparator drug or the drug administration period (with cross-over design) for assessment of the drug efficacy, safety and tolerability.

Condition	Intervention	Phase
Asthma Allergic Rhinitis	Drug: MK0476; montelukast sodium/Duration of Treatment: 16 weeks Drug: Comparator: theophylline ER/Duration of Treatment: 16 weeks	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	A Randomized, Open Label, Cross-Over Study Comparing Effectiveness for the Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Theophylline Montelukast sodium Montelukast Theophylline sodium glycinate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

FEV1

Secondary Outcome Measures:

AM-PEFR; daytime symptom score; treatment frequency of beta agonist; global assessment investigator's symptom assessment; Quality of Life Questionnaire for Adult Korean Asthmatics; QLQAKA

Estimated Enrollment:	68
Study Start Date:	May 2003

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females between the ages of 18 and 60 with mild to moderate asthma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157937

Locations

Korea, Republic of
MSD Korea Ltd.
Seoul, Korea, Republic of, 121-705

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Study ID Numbers:	2005_069
Study First Received:	September 7, 2005
Last Updated:	February 2, 2007
ClinicalTrials.gov Identifier:	NCT00157937 History of Changes
Health Authority:	Korea: Food and Drug Administration

Additional relevant MeSH terms:

Respiratory System Agents
Vasodilator Agents
Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Enzyme Inhibitors
Rhinitis
Cardiovascular Agents
Nose Diseases

Pharmacologic Actions
Leukotriene Antagonists
Montelukast
Phosphodiesterase Inhibitors
Respiratory Tract Diseases
Respiratory Tract Infections
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents
Theophylline

ClinicalTrials.gov processed this record on February 08, 2010