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

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Ciclesonide; Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Salmeterol Xinafoate

Criteria

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