Safety of Ciclesonide Nasal Spray Administered With Inhaled Fluticasone Dipropionate/Salmeterol i… (NCT00163488) | Clinical Trial Compass
CompletedPhase 3
Safety of Ciclesonide Nasal Spray Administered With Inhaled Fluticasone Dipropionate/Salmeterol in Adults With Perennial Allergic Rhinitis (BY9010/M1-409)
United States106 participantsStarted 2005-01
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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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