NCT00489346CompletedPhase 3
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 994
- Primary Endpoint
- Improvement of asthma with MK0476 and Fluticasone as measured by number of asthma rescue-free days
Study Overview
Brief Summary
A study to evaluate MK0476 and Fluticasone to control asthma in patients with mild persistent asthma.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 6 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Improvement of asthma with MK0476 and Fluticasone as measured by number of asthma rescue-free days
Time Frame: Duration of Trial
Secondary Outcomes
- Improved effect of MK0476 and fluticasone on FEV1 values(Duration of Trial)
Investigators
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