drugset / Trial / NCT00295022
Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levocetirizine | Unknown | 5 mg | Oral |
| Subject | Montelukast | Other / unclassified | 10 mg | Oral |