drugset / Trial / NCT01783548

Study of an Investigational Nasal Aerosol or Placebo in Children (Ages 4 to 11) With Perennial Allergic Rhinitis (PAR)

NCT01783548 ↗

Phase 3 Completed 547 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of Beclomethasone dipropionate (BDP) nasal aerosol in subjects with Perennial Allergic Rhinitis (PAR).

Timeline

Start
2013-01
Primary completion
2013-10
Completion
2013-10

Outcome

Met primary endpoint

registry BDP Nasal Aerosol 80 mcg/Day vs Placebo Nasal Aerosol; p = 0.002; LSM treatment difference from placebo -0.66 (95% CI -1.08 to -0.24) NCT01783548 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject beclomethasone dipropionate Other / unclassified 80 ug Other

Indications