Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)



Status:Completed
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:6 - 11
Updated:12/1/2016
Start Date:March 2006
End Date:October 2006

Use our guide to learn which trials are right for you!

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess the Safety and Efficacy of Ciclesonide (200mcg and 100mcg, Once Daily) Applied as a Nasal Spray for Two Weeks in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 6 to 11 Years of Age

The aim of the study is to determine the efficacy and safety of ciclesonide nasal spray in
children with seasonal allergic rhinitis. Ciclesonide will be administered intranasally at
two dose levels once daily. The study consists of a baseline period (1 to 3 weeks) and a
treatment period (2 weeks).


Main Inclusion Criteria:

- Written informed consent

- General good health other than seasonal allergic rhinitis

- Positive standard skin prick test

Main Exclusion Criteria:

- Pregnancy, nursing, or plans to become pregnant or donate gametes for in vitro
fertilization

- Participation in any investigational drug trial within the 30 days preceding the
Screening Visit

- A known hypersensitivity to any corticosteroid or any of the ingredients in the study
drug formulation

- Plans to travel outside the study area (the known pollen area for the investigative
site) for 24 hours or more during the final 7 days of the baseline period

- Plans to travel outside the study area (the known pollen area for the investigative
site) for more than 2 consecutive days OR more than 3 days total during the treatment
period

- Use of any prohibited concomitant medications

- Non-vaccinated exposure to or active infection with chickenpox or measles within the
21 days preceding the Screening Visit

- Use of antiepileptic drugs for epilepsy within 30 days of the Screening Visit

- Study participation by more than one patient from the same household
We found this trial at
68
sites
Kerrville, Texas 78028
1137
mi
from 91732
Kerrville, TX
Click here to add this to my saved trials
Ashland, Oregon 97520
616
mi
from 91732
Ashland, OR
Click here to add this to my saved trials
Atlanta, Georgia 30342
1918
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78731
1208
mi
from 91732
Austin, TX
Click here to add this to my saved trials
Bethesda, Maryland 20814
2276
mi
from 91732
Bethesda, MD
Click here to add this to my saved trials
Birmingham, Alabama 35235
1793
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
Blue Bell, Pennsylvania 19422
2369
mi
from 91732
Blue Bell, PA
Click here to add this to my saved trials
Brick, New Jersey 08724
2430
mi
from 91732
Brick, NJ
Click here to add this to my saved trials
Burke, Virginia 22015
2268
mi
from 91732
Burke, VA
Click here to add this to my saved trials
Charleston, South Carolina 29414
2175
mi
from 91732
Charleston, SC
Click here to add this to my saved trials
Charleston, SC, South Carolina 29407
2180
mi
from 91732
Charleston, SC, SC
Click here to add this to my saved trials
Charlottesville, Virginia 22911
2212
mi
from 91732
Charlottesville, VA
Click here to add this to my saved trials
Cincinnati, Ohio 45219
1879
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, OH, Ohio 45231
1878
mi
from 91732
Cincinnati, OH, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80907
804
mi
from 91732
Colorado Springs, CO
Click here to add this to my saved trials
Costa Mesa, California 92626
27
mi
from 91732
Costa Mesa, CA
Click here to add this to my saved trials
Dallas, Texas 75231
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
Denver, Colorado 80230
822
mi
from 91732
Denver, CO
Click here to add this to my saved trials
Eerie, Pennsylvania 16506
2113
mi
from 91732
Eerie, PA
Click here to add this to my saved trials
El Paso, Texas 79925
693
mi
from 91732
El Paso, TX
Click here to add this to my saved trials
Englewood, Colorado 80112
820
mi
from 91732
Englewood, CO
Click here to add this to my saved trials
Forked River, New Jersey 08731
2429
mi
from 91732
Forked River, NJ
Click here to add this to my saved trials
Gainesville, Georgia 30501
1944
mi
from 91732
Gainesville, GA
Click here to add this to my saved trials
Germantown, Tennessee 38138
1600
mi
from 91732
Germantown, TN
Click here to add this to my saved trials
Hot Springs, Arkansas 71913
1421
mi
from 91732
Hot Springs, AR
Click here to add this to my saved trials
Huntington Beach, California 92647
24
mi
from 91732
Huntington Beach, CA
Click here to add this to my saved trials
Indianapolis, Indiana 46208
1792
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
Jackson, Tennessee 38301
1653
mi
from 91732
Jackson, TN
Click here to add this to my saved trials
Jefferson City, Missouri 65109
1466
mi
from 91732
Jefferson City, MO
Click here to add this to my saved trials
Lake Oswego, Oregon 97035
822
mi
from 91732
Lake Oswego, OR
Click here to add this to my saved trials
Lakewood, CO, Colorado 80401
805
mi
from 91732
Lakewood, CO, CO
Click here to add this to my saved trials
Lincoln, NE, Nebraska 68505
1258
mi
from 91732
Lincoln, NE, NE
Click here to add this to my saved trials
Long Beach, California 90806
21
mi
from 91732
Long Beach, CA
Click here to add this to my saved trials
Los Alamitos, California 90720
18
mi
from 91732
Los Alamitos, CA
Click here to add this to my saved trials
Louisville, KY, Kentucky 40215
1811
mi
from 91732
Louisville, KY, KY
Click here to add this to my saved trials
Medford, OR, Oregon 97504
628
mi
from 91732
Medford, OR, OR
Click here to add this to my saved trials
Metairie, Louisiana 70006
1647
mi
from 91732
Metairie, LA
Click here to add this to my saved trials
Milwaukee, Wisconsin 53201
1728
mi
from 91732
Milwaukee, WI
Click here to add this to my saved trials
Minneapolis, Minnesota 55402
1509
mi
from 91732
Minneapolis, MN
Click here to add this to my saved trials
Mission Viejo, California 92691
37
mi
from 91732
Mission Viejo, CA
Click here to add this to my saved trials
New Braunfels, Texas 78130
1203
mi
from 91732
New Braunfels, TX
Click here to add this to my saved trials
Normal, Illinois 61761
1647
mi
from 91732
Normal, IL
Click here to add this to my saved trials
North Dartmouth, Massachusetts 02747
2586
mi
from 91732
North Dartmouth, MA
Click here to add this to my saved trials
Orange, California 92868
21
mi
from 91732
Orange, CA
Click here to add this to my saved trials
Overland Park, Kansas 66210
1333
mi
from 91732
Overland Park, KS
Click here to add this to my saved trials
Papillion, Nebraska 68046
1293
mi
from 91732
Papillion, NE
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15241
2114
mi
from 91732
Pittsburgh, PA
Click here to add this to my saved trials
Portland, Oregon 97213
828
mi
from 91732
Portland, OR
Click here to add this to my saved trials
Raleigh, North Carolina 27607
2215
mi
from 91732
Raleigh, NC
Click here to add this to my saved trials
Red Bank, New Jersey 07701
2431
mi
from 91732
Red Bank, NJ
Click here to add this to my saved trials
Richmond, Virginia 23226
2263
mi
from 91732
Richmond, VA
Click here to add this to my saved trials
Rochester, NY, New York 14618
2248
mi
from 91732
Rochester, NY, NY
Click here to add this to my saved trials
Rockville Centre, New York 11570
2452
mi
from 91732
Rockville Centre, NY
Click here to add this to my saved trials
Rolla, Missouri 65401
1485
mi
from 91732
Rolla, MO
Click here to add this to my saved trials
Roseville, California 95678
371
mi
from 91732
Roseville, CA
Click here to add this to my saved trials
Salt Lake City, Utah 84111
570
mi
from 91732
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78229
1182
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92103
103
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
San Jose, California 95117
314
mi
from 91732
San Jose, CA
Click here to add this to my saved trials
Savannah, Georgia 31406
2132
mi
from 91732
Savannah, GA
Click here to add this to my saved trials
Shreveport, Louisiana 71105
1405
mi
from 91732
Shreveport, LA
Click here to add this to my saved trials
Skillman, New Jersey 08558
2396
mi
from 91732
Skillman, NJ
Click here to add this to my saved trials
South Burlington, Vermont 05403
2470
mi
from 91732
South Burlington, VT
Click here to add this to my saved trials
St. Louis, Missouri 63141
1558
mi
from 91732
St. Louis, MO
Click here to add this to my saved trials
Stockton, California 95207
328
mi
from 91732
Stockton, CA
Click here to add this to my saved trials
Upland, Pennsylvania 19013
2364
mi
from 91732
Upland, PA
Click here to add this to my saved trials
Warren, New Jersey 07059
2407
mi
from 91732
Warren, NJ
Click here to add this to my saved trials
Woodstock, GA, Georgia 30188
1911
mi
from 91732
Woodstock, GA, GA
Click here to add this to my saved trials