drugset / Trial / NCT00720278

A Study to Evaluate the Safety and Efficacy of Two Nasal Sprays to Treat Seasonal Allergies

NCT00720278 ↗

Phase 3 Completed 526 enrolled Meda Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study was to determine if two allergy medications are more effective than placebo.

Timeline

Start
2007-08
Primary completion
2007-10
Completion
2007-11

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Astepro 0.1%; p <0.001; Mean Difference (Final Values) -2.06 (95% CI -2.98 to -1.14); ANCOVA NCT00720278 ↗

registry analysis (superiority or other test); Placebo vs Astepro 0.15%; p <0.001; Mean Difference (Final Values) -3.00 (95% CI -3.91 to -2.09); ANCOVA NCT00720278 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Azelastine Small molecule 1096 ug Intranasal
Subject Azelastine Small molecule 1644 ug Intranasal