Safety of Ciclesonide Nasal Spray Administered With Inhaled Fluticasone Dipropionate/Salmeterol in Adults With Perennial Allergic Rhinitis (BY9010/M1-409)
Phase 3
Completed
- Conditions
- Perennial Allergic RhinitisAllergic RhinitisHay Fever
- Registration Number
- NCT00163488
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method safety.
- Secondary Outcome Measures
Name Time Method safety and tolerability.
Trial Locations
- Locations (1)
Altana Pharma/Nycomed
🇺🇸Long Beach, California, United States