A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR).

Perennial Allergic Rhinitis Clinical Trial

Official title: A 12-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis

Status Completed

Clinical Trial Summary

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.

Clinical Trial Description

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR. This study will consist of the following periods/visits: Screening , Single-blind Placebo Run-in period, Double-blind Treatment period , Follow-up. The total duration of subject participation will be approximately 5 months. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• PAR
• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic, Perennial

• NCT number: NCT01451541
• Study type: Interventional
• Source: Sunovion
• Status: Completed
• Phase: Phase 3
• Start date: October 2011
• Completion date: December 2012