Status:
COMPLETED
Safety of Ciclesonide Nasal Spray Administered With Inhaled Fluticasone Dipropionate/Salmeterol in Adults With Perennial Allergic Rhinitis (BY9010/M1-409)
Lead Sponsor:
AstraZeneca
Conditions:
Perennial Allergic Rhinitis
Allergic Rhinitis
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00163488
Start Date
January 1 2005
End Date
August 1 2005
Last Update
December 5 2016
Active Locations (1)
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1
Altana Pharma/Nycomed
Long Beach, California, United States, 90806