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

This study has been completed.

Sponsored by:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00261287

Purpose

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	Intervention	Phase
Hay Fever Perennial Allergic Rhinitis	Drug: Ciclesonide	Phase III

MedlinePlus related topics: Fever Hay Fever

Drug Information available for: Ciclesonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
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

Further study details as provided by ALTANA Pharma:

Primary Outcome Measures:

Safety and tolerability of ciclesonide nasal spray

Estimated Enrollment:	102
Study Start Date:	November 2005

Eligibility

Ages Eligible for Study:	2 Years to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00261287

Locations

United States, California
Altana Pharma/Nycomed
Long Beach, California, United States, 90806
United States, Illinois
Altana Pharma/Nycomed
Normal, Illinois, United States, 61761
United States, Texas
Altana Pharma/Nycomed
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

ALTANA Pharma

Investigators

Study Chair:

Mark A. Wingertzahn, PhD

ALTANA Pharma, Florham Park, NJ 07932, USA

More Information

Study ID Numbers:	BY9010/M1-416
Study First Received:	December 2, 2005
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00261287
Health Authority:	United States: Food and Drug Administration

Keywords provided by ALTANA Pharma:

Hay Fever
Allergic Rhinitis
Perennial Allergic Rhinitis
Ciclesonide

Study placed in the following topic categories:

Fever
Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis, Allergic, Perennial

Ciclesonide
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Rhinitis
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Therapeutic Uses
Anti-Allergic Agents
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on January 14, 2009