Phase 3 N=421 Randomized Double-blind Treatment

Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT00289874 ↗

Enrolled (actual)

421

Serious AEs

1.0%

Results posted

Oct 2010

Primary outcome: Primary: Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3 — 9.53; 9.15 Percent Change

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: montelukast sodium (Drug); Comparator: Placebo (Drug)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Jul 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3	9.53; 9.15	—
SECONDARY Percent Change From Baseline in Mean Daily "as Needed" β-agonist Use Over the 3-week Treatment Period	-18.88; -12.40	—

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.

Eligibility Criteria

Inclusion Criteria

Male and female patients, ages 6 to 14 years, with persistent asthma that is also active during allergy season
Patients must demonstrate positive skin prick tests to seasonally relevant geographic aeroallergens

Exclusion Criteria

Patient cannot have any other acute or chronic pulmonary disorder

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00289874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.