Back to resultsA Study to Evaluate MK0476 and Fluticasone to Control Asthma in Patients With Mild Persistent Asthma (0476-910)
Primary Purpose
Asthma, Bronchial
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0476, montelukast sodium / Duration of Treatment: 1 Year
Comparator : fluticasone propionate / Duration of Treatment: 1 Year
Sponsored by
About this trial
This is an interventional treatment trial for Asthma, Bronchial
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Improvement of asthma with MK0476 and Fluticasone as measured by number of asthma rescue-free days
Secondary Outcome Measures
Improved effect of MK0476 and fluticasone on FEV1 values
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00489346
Brief Title
A Study to Evaluate MK0476 and Fluticasone to Control Asthma in Patients With Mild Persistent Asthma (0476-910)
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
June 2002 (Actual)
Study Completion Date
June 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
Brief Summary
A study to evaluate MK0476 and Fluticasone to control asthma in patients with mild persistent asthma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Bronchial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
994 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0476, montelukast sodium / Duration of Treatment: 1 Year
Intervention Type
Drug
Intervention Name(s)
Comparator : fluticasone propionate / Duration of Treatment: 1 Year
Primary Outcome Measure Information:
Title
Improvement of asthma with MK0476 and Fluticasone as measured by number of asthma rescue-free days
Time Frame
Duration of Trial
Secondary Outcome Measure Information:
Title
Improved effect of MK0476 and fluticasone on FEV1 values
Time Frame
Duration of Trial
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
16061590
Citation
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. doi: 10.1542/peds.2004-1172. Erratum In: Pediatrics. 2005 Oct;116(4):1058.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
A Study to Evaluate MK0476 and Fluticasone to Control Asthma in Patients With Mild Persistent Asthma (0476-910)
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