A 6 Month Safety and Efficacy Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) in the Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older

Summary

This is a 6-month multi-center, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide HFA nasal aerosol administered once-daily to male and female subjects 12 years or older diagnosed with perennial allergic rhinitis (PAR).

Timeline

Start

2009-08

Primary completion

2010-01

Completion

2010-05

Outcome

Met primary endpoint

registry Ciclesonide HFA 80 Mcg Once Daily vs Placebo Once Daily; p <0.0001; Mean Difference (Final Values) 0.69 (95% CI 0.35 to 1.04) NCT00953147 ↗

registry Ciclesonide HFA 160 Mcg Once Daily vs Placebo Once Daily; p = 0.0005; Mean Difference (Final Values) 0.54 (95% CI 0.24 to 0.84) NCT00953147 ↗

Publications

• Results Mohar D, Berger WE, Laforce C, Raphael G, Desai SY, Huang H, Hinkle J. Efficacy and tolerability study of ciclesonide nasal aerosol in patients with perennial allergic rhinitis. Allergy Asthma Proc. 2012 Jan-Feb;33(1):19-26. doi: 10.2500/aap.2012.33.3522.

Drugs

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

Indications