A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess the Safety and Tolerability of Ciclesonide (200 mcg Once Daily), Applied as a Nasal Spray for Twelve Weeks, in the Treatment of Perennial Allergic Rhinitis (PAR) in Pediatric Patients 2-5 Years of Age

AstraZeneca1 site in 1 country102 target enrollmentNovember 2005

ConditionsHay Fever Perennial Allergic Rhinitis

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hay Fever
Sponsor: AstraZeneca
Enrollment: 102
Locations: 1
Primary Endpoint: Safety and tolerability of ciclesonide nasal spray
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of ciclesonide nasal spray for long term use in relieving symptoms in perennial allergic rhinitis.

Registry

clinicaltrials.gov

Start Date

November 2005

End Date

June 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•General good health, other than perennial allergic rhinitis
•History and diagnosis of perennial allergic rhinitis by skin prick test
•History of perennial allergic rhinitis for a minimum of 90 days immediately before the screening visit

Exclusion Criteria

•Participation in any investigational drug trial within the 30 days before the screening visit
•Use of any disallowed concomitant medications within the prescribed withdrawal periods before the screening visit
•A known hypersensitivity to any corticosteroid