Safety and Effectiveness of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis During One Year Treatment (BY9010/M1-404)

This study has been completed.

Sponsored by:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00163501

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

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, Single Group Assignment
Official Title:	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

Further study details as provided by ALTANA Pharma:

Primary Outcome Measures:

change in Total Nasal Symptom Scores.

Secondary Outcome Measures:

change in symptoms, quality of life, safety.

Estimated Enrollment:	600
Study Start Date:	December 2003
Estimated Study Completion Date:	April 2005

Eligibility

Ages Eligible for Study:	12 Years and older
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

Main 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163501

Show 41 Study Locations

Sponsors and Collaborators

ALTANA Pharma

Investigators

Study Chair:

Mark A. Wingertzahn, Ph.D.

Altana Pharma, Florham Park, NJ 07932, USA

More Information

Study ID Numbers:	BY9010/M1-404
Study First Received:	September 12, 2005
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00163501
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
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 16, 2009