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



Status:Completed
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:6 - 11
Updated:12/3/2016
Start Date:May 2004
End Date:July 2005

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.


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
We found this trial at
56
sites
Altana Pharma/Nycomed
San Diego, California 92103
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Altana Pharma/Nycomed
Atlanta, Georgia 30342
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Altana Pharma/Nycomed
Austin, Texas 78731
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Austin, TX
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Altana Pharma/Nycomed
Brick, New Jersey 08724
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Brick, NJ
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Altana Pharma/Nycomed
Burke, Virginia 22015
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Burke, VA
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Altana Pharma/Nycomed
Canton, Ohio 44718
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Canton, OH
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Altana Pharma/Nycomed
Charleston, South Carolina 29414
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Charleston, SC
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Altana Pharma/Nycomed
Cincinnati, OH, Ohio 45231
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Cincinnati, OH, OH
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Altana Pharma/Nycomed
Coral Gables, Florida 33134
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Altana Pharma/Nycomed
Dubuque, Iowa 52001
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Dubuque, IA
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Altana Pharma/Nycomed
Easton, Pennsylvania 18045
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Easton, PA
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Altana Pharma/Nycomed
El Paso, Texas 79925
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El Paso, TX
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Altana Pharma/Nycomed
Fort Worth, Texas 76132
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Altana Pharma/Nycomed
Friendswood, Texas 77546
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Friendswood, TX
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Altana Pharma/Nycomed
Gainesville, Georgia 30501
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Gainesville, GA
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Altana Pharma/Nycomed
Hamilton, ON,
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Altana Pharma/Nycomed
Hershey, Pennsylvania 17033
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Altana Pharma/Nycomed
Houston, Texas 77054
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Houston, TX
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Altana Pharma/Nycomed
Huntington Beach, California 92647
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Altana Pharma/Nycomed
Indianapolis, Indiana 46208
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Indianapolis, IN
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Altana Pharma/Nycomed
Jefferson City, Missouri 65109
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Altana Pharma/Nycomed
Katy, Texas 77450
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Altana Pharma/Nycomed
Liverpool, New York 13088
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Altana Pharma/Nycomed
Medford, Oregon 97504
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Medford, OR
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Metairie, Louisiana 70006
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Metairie, LA
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Altana Pharma/Nycomed
Minneapolis, Minnesota 55402
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Minneapolis, MN
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Altana Pharma/Nycomed
Mission Viejo, California 92691
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Altana Pharma/Nycomed
Moncks Corner, South Carolina 29461
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Newport Beach, California 92660
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Altana Pharma/Nycomed
Normal, Illinois 61761
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Normal, IL
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North Dartmouth, Massachusetts 02747
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Altana Pharma/Nycomed
Ocala, Florida 34471
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Orange, California 92868
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Overland Park, Kansas 66210
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Oxford, Alabama 36203
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Oxford, AL
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Palmdale, California 93551
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Papillion, Nebraska 68046
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Portland, Oregon 97213
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Altana Pharma/Nycomed
Raleigh, North Carolina 27607
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Altana Pharma/Nycomed
Richmond, Virginia 23226
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Altana Pharma/Nycomed
Rockville, Maryland 20850
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Rolla, Mo, Missouri 65401
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Altana Pharma/Nycomed
Salt Lake City, Utah 84111
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Altana Pharma/Nycomed
San Jose, California 95117
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Altana Pharma/Nycomed
Savannah, Georgia 31406
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Shreveport, Louisiana 71105
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Skillman, New Jersey 08558
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Altana Pharma/Nycomed
South Burlington, Vermont 05403
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Spartanburg, South Carolina 29307
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Spokane, Washington 99202
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St. Louis, Missouri 63141
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Stockton, California 95207
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Sylvania, Ohio 43560
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Upland, Pennsylvania 19013
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Walnut Creek, CA, California 94598
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Altana Pharma/Nycomed
Wheaton, Maryland 20902
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