Safety and Effectiveness of Ciclesonide Nasal Spray in Children (6 to 11 Years) With Perennial Allergic Rhinitis (BY9010/M1-403)
Phase 3
Completed
- Conditions
- Hay FeverPerennial Allergic RhinitisAllergic Rhinitis
- Registration Number
- NCT00163514
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of perennial allergic rhinitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 636
Inclusion Criteria
- General good health, other than perennial allergic rhinitis
- History and diagnosis of perennial allergic rhinitis by skin prick test
- Parent/caregiver must be capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent and comply with all study requirements (visits, record-keeping, etc.)
Main
Exclusion Criteria
- Participation in any investigational drug trial within the 30 days preceding the Screening Visit or at any time during the trial
- Use of any prohibited concomitant medications as defined by the study protocol
- 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 changes in Total Nasal Symptom Score
- Secondary Outcome Measures
Name Time Method safety, changes in symptoms
Trial Locations
- Locations (1)
Altana Pharma/Nycomed
🇨🇦Winnipeg, Canada