At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 421 enrolled
Drug / intervention
montelukast sodium +1 moredrug
Likely dose
montelukast sodium 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Double-Blind, Placebo Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral Montelukast Versus Placebo in Persistent Asthma Which is Also Active During Allergy Seasons in Pediatric Patients With Seasonal Aeroallergen Sensitivity
In Brief
A Phase 3 clinical trial evaluating montelukast sodium and Comparator: Placebo for Asthma. Completed, enrolled 421 participants.
Detailed Summary
This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma which is also active during allergy seasons in pediatric patients with seasonal aeroallergen sensitivity.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2006
Enrollment StartMar 2006
Primary CompletionJul 2007
TodayJul 2026
First PostedFeb 10, 2006
Enrollment StartMar 1, 2006
Primary CompletionJul 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.4 years ago
Interventions
montelukast sodiumdrug
montelukast 5 mg chewable tablet once daily. Up to 3 weeks of treatment.
Comparator: Placebodrug
Placebo. Up to 3 weeks of treatment