Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416)

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00261287

Collaborator

(none)

102

Enrollment

Locations

Duration (Months)

Patients Per Site

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hay Fever Perennial Allergic Rhinitis	Drug: Ciclesonide	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Jun 1, 2006

Actual Study Completion Date :

Jun 1, 2006

Outcome Measures

Primary Outcome Measures

Safety and tolerability of ciclesonide nasal spray []

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Main 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

Main 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Altana Pharma/Nycomed	Long Beach	California	United States	90806
2	Altana Pharma/Nycomed	Normal	Illinois	United States	61761
3	Altana Pharma/Nycomed	San Antonio	Texas	United States	78229