Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to determine the efficacy and safety of ciclesonide nasal spray in children with seasonal allergic rhinitis. Ciclesonide will be administered intranasally at two dose levels once daily. The study consists of a baseline period (1 to 3 weeks) and a treatment period (2 weeks).

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

Details

• Lead Sponsor: AstraZeneca
• Treatments: Ciclesonide

Criteria

Main Inclusion Criteria:

• Written informed consent

• General good health other than seasonal allergic rhinitis

• Positive standard skin prick test

Main Exclusion Criteria:

• Pregnancy, nursing, or plans to become pregnant or donate gametes for in vitro fertilization

• Participation in any investigational drug trial within the 30 days preceding the Screening Visit

• A known hypersensitivity to any corticosteroid or any of the ingredients in the study drug formulation

• Plans to travel outside the study area (the known pollen area for the investigative site) for 24 hours or more during the final 7 days of the baseline period

• Plans to travel outside the study area (the known pollen area for the investigative site) for more than 2 consecutive days OR more than 3 days total during the treatment period

• Use of any prohibited concomitant medications

• Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the Screening Visit

• Use of antiepileptic drugs for epilepsy within 30 days of the Screening Visit

• Study participation by more than one patient from the same household