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

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00489346

First received: June 20, 2007

Last updated: September 23, 2009

Last verified: September 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

June 20, 2007

Last Updated Date

September 23, 2009

Start Date ^ICMJE

July 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00489346 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Asthma, Bronchial

Intervention ^ICMJE

Drug: MK0476, montelukast sodium / Duration of Treatment: 1 Year
Drug: Comparator : fluticasone propionate / Duration of Treatment: 1 Year

Study Arm (s)

Not Provided

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1000

Completion Date

June 2003

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 14 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00489346

Other Study ID Numbers ^ICMJE

2007_574

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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