Clinical Trial to Assess the Efficacy and Safety of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol for the Treatment of Seasonal Allergic Rhinitis

Summary

To demonstrate the efficacy of ciclesonide HFA applied as a nasal aerosol (160 μg and 80 μg) once daily compared to placebo in subjects with SAR.

Timeline

Start

2008-11

Primary completion

2009-02

Completion

2009-02

Outcome

Met primary endpoint

registry analysis (superiority or other test); 80 mcg Ciclesonide vs Placebo; p <0.0001; Mean Difference (Final Values) 0.94 (95% CI 0.57 to 1.32) NCT00790023 ↗

registry analysis (superiority or other test); 160 mcg Ciclesonide vs Placebo; p <0.0001; Mean Difference (Final Values) 1.08 (95% CI 0.70 to 1.45) NCT00790023 ↗

Publications

• Results Ratner P, Jacobs R, Mohar D, Huang H, Desai SY, Hinkle J. Evaluation of the efficacy and safety of ciclesonide hydrofluoroalkane nasal aerosol, 80 or 160 mug once daily, for the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2010 Dec;105(6):471-9. doi: 10.1016/j.anai.2010.09.024.

Drugs

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

Indications