Safety and Effectiveness of Ciclesonide Nasal Spray in Children (6 to 11 Years) With Perennial Allergic Rhinitis (BY9010/M1-403)

This study has been completed.

First Received: September 12, 2005 Last Updated: July 16, 2008 History of Changes

Sponsored by:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00163514

Purpose

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.

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

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Fever Hay Fever

Drug Information available for: Ciclesonide

U.S. FDA Resources

Further study details as provided by ALTANA Pharma:

Primary Outcome Measures:

changes in Total Nasal Symptom Score

Secondary Outcome Measures:

safety, changes in symptoms

Estimated Enrollment:	636
Study Start Date:	May 2004
Estimated Study Completion Date:	February 2005

Eligibility

Ages Eligible for Study:	6 Years to 11 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
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.)

Main 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163514

Show 74 Study Locations

Sponsors and Collaborators

ALTANA Pharma

Investigators

Study Chair:

Mark A. Wingertzahn, Ph.D.

Altana Pharma, Florham Park, NJ 07932, USA

More Information

No publications provided

Study ID Numbers:	BY9010/M1-403
Study First Received:	September 12, 2005
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00163514 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by ALTANA Pharma:

Allergy
Perennial Allergic Rhinitis
Allergic Rhinitis
Hay Fever

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
Anti-Allergic Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Otorhinolaryngologic Diseases
Immune System Diseases
Ciclesonide
Rhinitis
Anti-Allergic Agents
Pharmacologic Actions
Nose Diseases
Hypersensitivity

Rhinitis, Allergic, Perennial
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 11, 2009