Safety and Effectiveness of Ciclesonide Nasal Spray in Children (6 to 11 Years) With Perennial Allergic Rhinitis (BY9010/M1-403)

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: AstraZeneca
• Treatments: Ciclesonide

Criteria

Main 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