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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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
Sylvania, Ohio 43560
126
mi
from 43215
Sylvania, OH
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Atlanta, Georgia 30342
426
mi
from 43215
Atlanta, GA
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Austin, Texas 78731
1062
mi
from 43215
Austin, TX
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Brick, New Jersey 08724
471
mi
from 43215
Brick, NJ
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Burke, Virginia 22015
317
mi
from 43215
Burke, VA
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Canton, Ohio 44718
102
mi
from 43215
Canton, OH
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Charleston, South Carolina 29414
519
mi
from 43215
Charleston, SC
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Cincinnati, OH, Ohio 45231
94
mi
from 43215
Cincinnati, OH, OH
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Coral Gables, Florida 33134
994
mi
from 43215
Coral Gables, FL
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Dubuque, Iowa 52001
433
mi
from 43215
Dubuque, IA
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Easton, Pennsylvania 18045
410
mi
from 43215
Easton, PA
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El Paso, Texas 79925
1417
mi
from 43215
El Paso, TX
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Fort Worth, Texas 76132
945
mi
from 43215
Fort Worth, TX
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Friendswood, Texas 77546
996
mi
from 43215
Friendswood, TX
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Gainesville, Georgia 30501
392
mi
from 43215
Gainesville, GA
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Hamilton, ON,
279
mi
from 43215
Hamilton, ON,
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Hershey, Pennsylvania 17033
337
mi
from 43215
Hershey, PA
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Houston, Texas 77054
996
mi
from 43215
Houston, TX
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Huntington Beach, California 92647
1968
mi
from 43215
Huntington Beach, CA
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Indianapolis, Indiana 46208
167
mi
from 43215
Indianapolis, IN
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Jefferson City, Missouri 65109
498
mi
from 43215
Jefferson City, MO
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Katy, Texas 77450
1007
mi
from 43215
Katy, TX
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Liverpool, New York 13088
413
mi
from 43215
Liverpool, NY
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Medford, Oregon 97504
2060
mi
from 43215
Medford, OR
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Metairie, Louisiana 70006
795
mi
from 43215
Metairie, LA
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Minneapolis, Minnesota 55402
625
mi
from 43215
Minneapolis, MN
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Mission Viejo, California 92691
1953
mi
from 43215
Mission Viejo, CA
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Moncks Corner, South Carolina 29461
496
mi
from 43215
Moncks Corner, SC
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Newport Beach, California 92660
1963
mi
from 43215
Newport Beach, CA
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Normal, Illinois 61761
316
mi
from 43215
Normal, IL
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North Dartmouth, Massachusetts 02747
640
mi
from 43215
North Dartmouth, MA
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Ocala, Florida 34471
748
mi
from 43215
Ocala, FL
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Orange, California 92868
1959
mi
from 43215
Orange, CA
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Overland Park, Kansas 66210
626
mi
from 43215
Overland Park, KS
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Oxford, Alabama 36203
465
mi
from 43215
Oxford, AL
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Palmdale, California 93551
1955
mi
from 43215
Palmdale, CA
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Papillion, Nebraska 68046
687
mi
from 43215
Papillion, NE
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Portland, Oregon 97213
2023
mi
from 43215
Portland, OR
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Raleigh, North Carolina 27607
372
mi
from 43215
Raleigh, NC
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Richmond, Virginia 23226
339
mi
from 43215
Richmond, VA
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Rockville, Maryland 20850
318
mi
from 43215
Rockville, MD
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Rolla, Mo, Missouri 65401
489
mi
from 43215
Rolla, Mo, MO
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Salt Lake City, Utah 84111
1513
mi
from 43215
Salt Lake City, UT
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San Diego, California 92103
1951
mi
from 43215
San Diego, CA
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San Jose, California 95117
2092
mi
from 43215
San Jose, CA
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Savannah, Georgia 31406
561
mi
from 43215
Savannah, GA
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Shreveport, Louisiana 71105
788
mi
from 43215
Shreveport, LA
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Skillman, New Jersey 08558
439
mi
from 43215
Skillman, NJ
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South Burlington, Vermont 05403
591
mi
from 43215
South Burlington, VT
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Spartanburg, South Carolina 29307
351
mi
from 43215
Spartanburg, SC
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Spokane, Washington 99202
1776
mi
from 43215
Spokane, WA
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St. Louis, Missouri 63141
408
mi
from 43215
St. Louis, MO
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Stockton, California 95207
2045
mi
from 43215
Stockton, CA
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Upland, Pennsylvania 19013
404
mi
from 43215
Upland, PA
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Walnut Creek, CA, California 94598
2082
mi
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Walnut Creek, CA, CA
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Wheaton, Maryland 20902
325
mi
from 43215
Wheaton, MD
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