Safety of Ciclesonide Nasal Spray Administered With Inhaled Fluticasone Dipropionate/Salmeterol in Adults With Perennial Allergic Rhinitis (BY9010/M1-409)

Investigation of Potential Additive Inhibitory Effects on HPA-Axis of Ciclesonide Nasal Spray When Administered Concomitantly With Orally Inhaled Fluticasone Propionate/Salmeterol (FP/SAL) in Patients (18-60 Years) With Perennial Allergic Rhinitis (PAR)

The purpose of this study is to evaluate the safety and tolerability of combined ciclesonide nasal spray administered along with a fixed combination of inhaled fluticasone dipropionate/salmeterol.

Main Inclusion Criteria:

• General good health, other than perennial allergic rhinitis
• History and diagnosis of perennial allergic rhinitis by skin prick
• Normal body weight as defined by the study protocol

Main Exclusion Criteria:

• Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the study period
• Participation in any investigational drug trial within the 30 days preceding the Screening Visit
• A known hypersensitivity to any corticosteroid or any of the excipients in the formulations
• Use of any prohibited concomitant medications as defined by the study protocol
• Previous participation in an intranasal ciclesonide study
• Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit