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

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

MedlinePlus related topics: Fever Hay Fever

Drug Information available for: Ciclesonide

U.S. FDA Resources

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

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

Hide Study Locations

Locations

United States, Alabama
Altana Pharma/Nycomed
Oxford, Alabama, United States, 36203
United States, California
Altana Pharma/Nycomed
Walnut Creek, CA, California, United States, 94598
Altana Pharma/Nycomed
San Diego, California, United States, 92120
Altana Pharma/Nycomed
San Diego, California, United States, 92123
Altana Pharma/Nycomed
Palmdale, California, United States, 93551
Altana Pharma/Nycomed
Newport Beach, California, United States, CA 92660
Altana Pharma/Nycomed
Mission Viejo, California, United States, 92691
Altana Pharma/Nycomed
Orange, California, United States, 92868
Altana Pharma/Nycomed
Huntington Beach, California, United States, 92647
Altana Pharma/Nycomed
San Jose, California, United States, 95117
Altana Pharma/Nycomed
Stockton, California, United States, 95207
United States, Florida
Altana Pharma/Nycomed
Coral Gables, Florida, United States, 33134
Altana Pharma/Nycomed
Ocala, Florida, United States, 34471
United States, Georgia
Altana Pharma/Nycomed
Atlanta, Georgia, United States, 30342
Altana Pharma/Nycomed
Gainesville, Georgia, United States, 30501
Altana Pharma/Nycomed
Savannah, Georgia, United States, 31406
United States, Illinois
Altana Pharma/Nycomed
Normal, Illinois, United States, 61761
United States, Indiana
Altana Pharma/Nycomed
Indianapolis, Indiana, United States, 46208
United States, Iowa
Altana Pharma/Nycomed
Dubuque, Iowa, United States, 52001
United States, Kansas
Altana Pharma/Nycomed
Overland Park, Kansas, United States, 66210
United States, Louisiana
Altana Pharma/Nycomed
Shreveport, Louisiana, United States, 71130
Altana Pharma/Nycomed
Metairie, Louisiana, United States, 70001
United States, Maryland
Altana Pharma/Nycomed
Rockville, Maryland, United States, 20850
Altana Pharma/Nycomed
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Altana Pharma/Nycomed
North Dartmouth, Massachusetts, United States, 02747
United States, Minnesota
Altana Pharma/Nycomed
Minneapolis, Minnesota, United States, 55402
United States, Missouri
Altana Pharma/Nycomed
Rolla, Mo, Missouri, United States, 65401
Altana Pharma/Nycomed
St. Louis, Missouri, United States, 63141
Altana Pharma/Nycomed
Jefferson City, Missouri, United States, 65101
United States, Nebraska
Altana Pharma/Nycomed
Papillion, Nebraska, United States, 68046
United States, New Jersey
Altana Pharma/Nycomed
Skillman, New Jersey, United States, 08558
Altana Pharma/Nycomed
Brick, New Jersey, United States, 08724
United States, New York
Altana Pharma/Nycomed
Liverpool, New York, United States, 13088
United States, North Carolina
Altana Pharma/Nycomed
Raleigh, North Carolina, United States, 27607
United States, Ohio
Altana Pharma/Nycomed
Cincinnati, OH, Ohio, United States, 45231
Altana Pharma/Nycomed
Sylvania, Ohio, United States, 43560
Altana Pharma/Nycomed
Canton, Ohio, United States, 44718
United States, Oregon
Altana Pharma/Nycomed
Portland, Oregon, United States, 97213
Altana Pharma/Nycomed
Medford, Oregon, United States, 97504
United States, Pennsylvania
Altana Pharma/Nycomed
Hershey, Pennsylvania, United States, 17033
Altana Pharma/Nycomed
Upland, Pennsylvania, United States, 19013
Altana Pharma/Nycomed
Easton, Pennsylvania, United States, 18045
United States, South Carolina
Altana Pharma/Nycomed
Spartanburg, South Carolina, United States, 29307
Altana Pharma/Nycomed
Charleston, South Carolina, United States, 29407
Altana Pharma/Nycomed
Moncks Corner, South Carolina, United States, 29461
Altana Pharma/Nycomed
Charleston, South Carolina, United States, 29414
United States, Texas
Altana Pharma/Nycomed
Friendswood, Texas, United States, 77546
Altana Pharma/Nycomed
El Paso, Texas, United States, 79925
Altana Pharma/Nycomed
Fort Worth, Texas, United States, 76132
Altana Pharma/Nycomed
Houston, Texas, United States, 77054
Altana Pharma/Nycomed
Katy, Texas, United States, 77450
Altana Pharma/Nycomed
Austin, Texas, United States, 78750
United States, Utah
Altana Pharma/Nycomed
Salt Lake City, Utah, United States, 84037
United States, Vermont
Altana Pharma/Nycomed
South Burlington, Vermont, United States, 05403
United States, Virginia
Altana Pharma/Nycomed
Burke, Virginia, United States, 22015
Altana Pharma/Nycomed
Richmond, Virginia, United States, 23219
Altana Pharma/Nycomed
Richmond, Virginia, United States, 23226
United States, Washington
Altana Pharma/Nycomed
Spokane, Washington, United States, 99202
Canada
Altana Pharma/Nycomed
Ste-Foy PQ, Canada, G1V 4M6
Altana Pharma/Nycomed
Montreal, QC, Canada, H3T 1C5
Altana Pharma/Nycomed
Ottawa, ON, Canada, K1S 0G8
Altana Pharma/Nycomed
Ottawa, Canada, K1Y 4G2
Altana Pharma/Nycomed
Kanata, ON, Canada, K2L 3C8
Altana Pharma/Nycomed
Oshawa, ON, Canada, L1H1B9
Altana Pharma/Nycomed
Niagara Falls, Canada, L2G 1J4
Altana Pharma/Nycomed
Saskatoon,SK, Canada, S7H 0W2
Altana Pharma/Nycomed
Hamilton, ON, Canada, L8N 1Y2
Altana Pharma/Nycomed
Hamilton, Canada, L8N 3Z5
Altana Pharma/Nycomed
Toronto, ON, Canada, M3H 5S4
Altana Pharma/Nycomed
Toronto, Canada, M4V 1R2
Altana Pharma/Nycomed
London,ON, Canada, N6A1V2
Altana Pharma/Nycomed
London, Canada, N6C 4Y7
Altana Pharma/Nycomed
Winnipeg, Canada, R2M 5L9
Altana Pharma/Nycomed
Mississauga, Canada, L5B 1N1

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 May 11, 2009