Study of an Investigational Nasal Aerosol or Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies

Phase 3 Completed 715 enrolled Teva Branded Pharmaceutical Products R&D, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the safety and efficacy of an investigational nasal aerosol at two doses compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis in children (6-11 years of age).

Timeline

Start: 2011-03
Primary completion: 2011-07
Completion: 2011-08

Outcome

Met primary endpoint

registry BDP HFA 80 mcg/Day vs Placebo Nasal Aerosol Once Daily; p <0.001; LSM treatment difference from placebo -0.71 (95% CI -1.1 to -0.3) NCT01307319 ↗

registry BDP HFA 160 mcg/Day vs Placebo Nasal Aerosol Once Daily; p <0.001; LSM treatment difference from placebo -0.76 (95% CI -1.1 to -0.4) NCT01307319 ↗

Publications

Storms WW, Segall N, Mansfield LE, Amar NJ, Kelley L, Ding Y, Tantry SK. Efficacy and safety of beclomethasone dipropionate nasal aerosol in pediatric patients with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2013 Nov;111(5):408-414.e1. doi: 10.1016/j.anai.2013.07.033. Epub 2013 Aug 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	beclomethasone dipropionate	Other / unclassified	80 ug	Intranasal
Subject	beclomethasone dipropionate	Other / unclassified	160 ug	Intranasal