A Study to Compare Effectiveness of Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics - Full Text View

Sponsored by:	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

MedlinePlus related topics: Asthma Dietary Sodium

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

U.S. FDA Resources

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

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

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

Study placed in the following topic categories:

Montelukast
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

Asthma
Rhinitis
Leukotriene Antagonists
Theophylline

Additional relevant MeSH terms:

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

Cardiovascular Agents
Nose Diseases
Pharmacologic Actions
Phosphodiesterase Inhibitors
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 15, 2009