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NCT00489346 Clinical Trial

A Study to Evaluate MK0476 and Fluticasone to Control Asthma in Patients With Mild Persistent Asthma (0476-910)

Asthma, Bronchial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00489346
Other study ID # 0476-910
Secondary ID 2007_574
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2001
Est. completion date June 2002

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 994
Est. completion date June 2002
Est. primary completion date June 2002
Accepts healthy volunteers No
Gender All
Age group 6 Years to 14 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0476, montelukast sodium / Duration of Treatment: 1 Year

• Comparator : fluticasone propionate / Duration of Treatment: 1 Year

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement of asthma with MK0476 and Fluticasone as measured by number of asthma rescue-free days Duration of Trial
Secondary Improved effect of MK0476 and fluticasone on FEV1 values Duration of Trial
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