A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial Designed to Assess the Efficacy and Safety of Ciclesonide Applied as a Nasal Spray at Three Dose Levels (200 Mcg, 100 Mcg, or 25 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 6-11 Years of Age

AstraZeneca1 site in 1 country636 target enrollmentMay 2004

ConditionsPerennial Allergic Rhinitis Allergic Rhinitis Hay Fever

DrugsCiclesonide

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Perennial Allergic Rhinitis
Sponsor: AstraZeneca
Enrollment: 636
Locations: 1
Primary Endpoint: changes in Total Nasal Symptom Score
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

May 2004

End Date

July 2005

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
•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.)

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