A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial to Assess the Long Term Safety of Ciclesonide, Applied as a Nasal Spray (200 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 12 Years and Older

AstraZeneca1 site in 1 country600 target enrollmentDecember 2003

ConditionsPerennial Allergic Rhinitis Allergic Rhinitis Hay Fever

DrugsCiclesonide

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Perennial Allergic Rhinitis
Sponsor: AstraZeneca
Enrollment: 600
Locations: 1
Primary Endpoint: change in Total Nasal Symptom Scores.
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 investigate the safety and effectiveness of ciclesonide nasal spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of perennial allergic rhinitis.

Registry

clinicaltrials.gov

Start Date

December 2003

End Date

April 2005

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

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

Exclusion Criteria

•Participation in any investigational drug trial within the 30 days preceding the Screening Visit
•A known hypersensitivity to any corticosteroid or any of the excipients in the formulation
•Use of any prohibited concomitant medications as defined by the study protocol