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

December 1, 2016 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

636

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
changes in Total Nasal Symptom Score

Secondary Outcome Measures

Outcome Measure
safety, changes in symptoms

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

December 2, 2016

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BY9010/M1-403

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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