A Study to Evaluate MK0476 and Fluticasone to Control Asthma in Patients With Mild Persistent Asthma

This study has been completed.

First Received on June 20, 2007. Last Updated on September 23, 2009 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00489346

Purpose

A study to evaluate MK0476 and Fluticasone to control asthma in patients with mild persistent asthma.

Condition	Intervention	Phase
Asthma, Bronchial	Drug: MK0476, montelukast sodium / Duration of Treatment: 1 Year Drug: Comparator : fluticasone propionate / Duration of Treatment: 1 Year	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Double-Blind, Randomized, Double-Dummy, Multicenter Study to Evaluate and Compare Oral Montelukast and Inhaled Fluticasone in the Control of Asthma for 6- to 14-Year-Olds With Mild Persistent Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Fluticasone Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Improvement of asthma with MK0476 and Fluticasone as measured by number of asthma rescue-free days [ Time Frame: Duration of Trial ]

Secondary Outcome Measures:

Improved effect of MK0476 and fluticasone on FEV1 values [ Time Frame: Duration of Trial ]

Estimated Enrollment:	1000
Study Start Date:	July 2001
Study Completion Date:	June 2003

Eligibility

Ages Eligible for Study:	6 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is male or female, 6-14 years of age with mild persistent asthma
Patient has a history of the following symptoms: wheezing, chest tightness, cough, etc.
Patient has asthma diagnosed by a doctor

Exclusion Criteria:

Patient is hospitalized
Patient has had major surgery or participated in another clinical trial in the last 4 weeks
Patient has been on a breathing tube for asthma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489346

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Garcia Garcia ML, Wahn U, Gilles L, Swern A, Tozzi CA, Polos P. Montelukast, compared with fluticasone, for control of asthma among 6- to 14-year-old patients with mild asthma: the MOSAIC study. Pediatrics. 2005 Aug;116(2):360-9. Erratum in: Pediatrics. 2005 Oct;116(4):1058.

ClinicalTrials.gov Identifier:	NCT00489346 History of Changes
Other Study ID Numbers:	2007_574
Study First Received:	June 20, 2007
Last Updated:	September 23, 2009
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Montelukast
Bronchodilator Agents
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on February 09, 2012