Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Patients 12 Years and Older With SAR

Phase 2 Completed 487 enrolled Teva Branded Pharmaceutical Products R&D, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, 2-week, multi-center, dose-range-finding study in male or female patients (12 years and older) with SAR.

Timeline

Start: 2009-03
Primary completion: 2009-05
Completion: 2009-05

Outcome

Met primary endpoint

registry BDP HFA 320 µg/Day vs Placebo; p = 0.013; LS Mean Difference -0.63 (95% CI -1.13 to -0.13) NCT00854360 ↗

Publications

Raphael GD, Berger WE, Prenner BM, Finn AF Jr, Kelley L, Tantry SK. Efficacy, safety, and optimal dose selection of beclomethasone dipropionate nasal aerosol for seasonal allergic rhinitis in adolescents and adults. Curr Med Res Opin. 2013 Oct;29(10):1329-40. doi: 10.1185/03007995.2013.821055. Epub 2013 Aug 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	beclomethasone dipropionate	Other / unclassified	80 ug	Intranasal
Subject	beclomethasone dipropionate	Other / unclassified	160 ug	Intranasal
Subject	beclomethasone dipropionate	Other / unclassified	320 ug	Intranasal