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

Last updated: December 1, 2016
Sponsor: AstraZeneca
Overall Status: Completed

Phase

3

Condition

Allergy

Allergy (Pediatric)

Common Cold

Treatment

N/A

Clinical Study ID

NCT00163514
BY9010/M1-403
  • Ages 6-11
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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, andbenefits of study participation, and, as judged by the investigator, capable of givinginformed consent and comply with all study requirements (visits, record-keeping, etc.)

Exclusion

Main Exclusion Criteria:

  • Participation in any investigational drug trial within the 30 days preceding theScreening 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

Study Design

Total Participants: 636
Study Start date:
May 01, 2004
Estimated Completion Date:
July 31, 2005

Connect with a study center

  • Altana Pharma/Nycomed

    Hamilton, L8N 3Z5
    Canada

    Site Not Available

  • Altana Pharma/Nycomed

    Hamilton, ON, L8N 1Y2
    Canada

    Site Not Available

  • Altana Pharma/Nycomed

    Kanata, ON, K2L 3C8
    Canada

    Site Not Available

  • Altana Pharma/Nycomed

    London, N6C 4Y7
    Canada

    Site Not Available

  • Altana Pharma/Nycomed

    London,ON, N6A1V2
    Canada

    Site Not Available

  • Altana Pharma/Nycomed

    Mississauga, L5B 1N1
    Canada

    Site Not Available

  • Altana Pharma/Nycomed

    Montreal, QC, H3T 1C5
    Canada

    Site Not Available

  • Altana Pharma/Nycomed

    Niagara Falls, L2G 1J4
    Canada

    Site Not Available

  • Altana Pharma/Nycomed

    Oshawa, ON, L1H1B9
    Canada

    Site Not Available

  • Altana Pharma/Nycomed

    Ottawa, K1Y 4G2
    Canada

    Site Not Available

  • Altana Pharma/Nycomed

    Ottawa, ON, K1S 0G8
    Canada

    Site Not Available

  • Altana Pharma/Nycomed

    Saskatoon,SK, S7H 0W2
    Canada

    Site Not Available

  • Altana Pharma/Nycomed

    Ste-Foy PQ, G1V 4M6
    Canada

    Site Not Available

  • Altana Pharma/Nycomed

    Toronto, M4V 1R2
    Canada

    Site Not Available

  • Altana Pharma/Nycomed

    Toronto, ON, M3H 5S4
    Canada

    Site Not Available

  • Altana Pharma/Nycomed

    Winnipeg, R2M 5L9
    Canada

    Site Not Available

  • Altana Pharma/Nycomed

    Oxford, Alabama 36203
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Mission Viejo, California 92691
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Newport Beach, California CA 92660
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Orange, California 92868
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Palmdale, California 93551
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    San Diego, California 92123
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    San Jose, California 95117
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Stockton, California 95207
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Walnut Creek, CA, California 94598
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Ocala, Florida 34471
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Normal, Illinois 61761
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Indianapolis, Indiana 46208
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Dubuque, Iowa 52001
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Metairie, Louisiana 70001
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Shreveport, Louisiana 71130
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Wheaton, Maryland 20902
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    North Dartmouth, Massachusetts 02747
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Minneapolis, Minnesota 55402
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Jefferson City, Missouri 65101
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Rolla, Mo, Missouri 65401
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Papillion, Nebraska 68046
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Brick, New Jersey 08724
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Skillman, New Jersey 08558
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Liverpool, New York 13088
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Canton, Ohio 44718
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Cincinnati, OH, Ohio 45231
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Sylvania, Ohio 43560
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Medford, Oregon 97504
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Portland, Oregon 97213
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Easton, Pennsylvania 18045
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Upland, Pennsylvania 19013
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Moncks Corner, South Carolina 29461
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Spartanburg, South Carolina 29307
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Austin, Texas 78750
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    El Paso, Texas 79925
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Fort Worth, Texas 76132
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Friendswood, Texas 77546
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Houston, Texas 77054
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Katy, Texas 77450
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Salt Lake City, Utah 84037
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    South Burlington, Vermont 05403
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Burke, Virginia 22015
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Richmond, Virginia 23219
    United States

    Site Not Available

  • Altana Pharma/Nycomed

    Spokane, Washington 99202
    United States

    Site Not Available

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