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Montelukast in Pediatric Allergic Asthma
NCT00289874Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2006
- Primary completion
- Jul 2007
- Sponsor
- Organon & Co.
- Modality
- Small Molecules
- Drugs
- montelukast
- Conditions
- asthma
01
Overview
Phase 3, randomised, double-blind trial in asthma comparing Montelukast with Placebo (2 arms). Primary endpoint: Percent Change From Baseline in Forced Expiratory Volume in 1 Second at 3 weeks. Started Mar 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Montelukast
montelukast 5 mg chewable tablet once daily
Placebo
Placebo once daily
03
Endpoints
Primary
Percent Change From Baseline in Forced Expiratory Volume in 1 Second
Secondary
Percent Change From Baseline in Mean Daily 'as Needed' Beta-agonist Use
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