drugset / Trial / NCT00295022

Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects

NCT00295022 ↗

Phase 4 Completed 418 enrolled UCB Pharma
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.

Timeline

Start
2006-07-29
Primary completion
2006-10-01
Completion
2006-10-01

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo (PBO) vs Levocetirizine (LCTZ); p <0.001; Mean Difference (Final Values) -3.12 (95% CI -4.35 to -1.88); ANCOVA NCT00295022 ↗

registry analysis (superiority or other test); Placebo (PBO) vs Montelukast (MLKT); p <0.001; Median Difference (Final Values) -2.19 (95% CI -3.43 to -0.95); ANCOVA NCT00295022 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Levocetirizine Unknown 5 mg Oral
Subject Montelukast Other / unclassified 10 mg Oral