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

November 29, 2016 updated by: AstraZeneca

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

660

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Altana Pharma/Nycomed
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Altana Pharma/Nycomed
    • California
      • Costa Mesa, California, United States, 92626
        • Altana Pharma/Nycomed
      • Huntington Beach, California, United States, 92647
        • Altana Pharma/Nycomed
      • Long Beach, California, United States, 90806
        • Altana Pharma/Nycomed
      • Los Alamitos, California, United States, 90720
        • Altana Pharma/Nycomed
      • Mission Viejo, California, United States, 92691
        • Altana Pharma/Nycomed
      • Orange, California, United States, 92868
        • Altana Pharma/Nycomed
      • Roseville, California, United States, 95678
        • 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
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Altana Pharma/Nycomed
      • Denver, Colorado, United States, 80230
        • Altana Pharma/Nycomed
      • Englewood, Colorado, United States, 80112
        • Altana Pharma/Nycomed
      • Lakewood, CO, Colorado, United States, 80401
        • 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
      • Woodstock, GA, Georgia, United States, 30188
        • Altana Pharma/Nycomed
    • Illinois
      • Normal, Illinois, United States, 61761
        • Altana Pharma/Nycomed
    • Indiana
      • Indianapolis, Indiana, United States, 46208
        • Altana Pharma/Nycomed
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Altana Pharma/Nycomed
    • Kentucky
      • Louisville, KY, Kentucky, United States, 40215
        • Altana Pharma/Nycomed
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Altana Pharma/Nycomed
      • Shreveport, Louisiana, United States, 71105
        • Altana Pharma/Nycomed
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • 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, 65109
        • Altana Pharma/Nycomed
      • Rolla, Missouri, United States, 65401
        • Altana Pharma/Nycomed
      • St. Louis, Missouri, United States, 63141
        • Altana Pharma/Nycomed
    • Nebraska
      • Lincoln, NE, Nebraska, United States, 68505
        • Altana Pharma/Nycomed
      • Papillion, Nebraska, United States, 68046
        • Altana Pharma/Nycomed
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • Altana Pharma/Nycomed
      • Forked River, New Jersey, United States, 08731
        • Altana Pharma/Nycomed
      • Red Bank, New Jersey, United States, 07701
        • Altana Pharma/Nycomed
      • Skillman, New Jersey, United States, 08558
        • Altana Pharma/Nycomed
      • Warren, New Jersey, United States, 07059
        • Altana Pharma/Nycomed
    • New York
      • Rochester, NY, New York, United States, 14618
        • Altana Pharma/Nycomed
      • Rockville Centre, New York, United States, 11570
        • Altana Pharma/Nycomed
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Altana Pharma/Nycomed
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Altana Pharma/Nycomed
      • Cincinnati, OH, Ohio, United States, 45231
        • Altana Pharma/Nycomed
    • Oregon
      • Ashland, Oregon, United States, 97520
        • Altana Pharma/Nycomed
      • Lake Oswego, Oregon, United States, 97035
        • Altana Pharma/Nycomed
      • Medford, OR, Oregon, United States, 97504
        • Altana Pharma/Nycomed
      • Portland, Oregon, United States, 97213
        • Altana Pharma/Nycomed
    • Pennsylvania
      • Blue Bell, Pennsylvania, United States, 19422
        • Altana Pharma/Nycomed
      • Eerie, Pennsylvania, United States, 16506
        • Altana Pharma/Nycomed
      • Pittsburgh, Pennsylvania, United States, 15241
        • Altana Pharma/Nycomed
      • Pittsburgh, Pennsylvania, United States, 15202
        • Altana Pharma/Nycomed
      • Upland, Pennsylvania, United States, 19013
        • Altana Pharma/Nycomed
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Altana Pharma/Nycomed
      • Charleston, SC, South Carolina, United States, 29407
        • Altana Pharma/Nycomed
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Altana Pharma/Nycomed
      • Jackson, Tennessee, United States, 38301
        • Altana Pharma/Nycomed
    • Texas
      • Austin, Texas, United States, 78731
        • Altana Pharma/Nycomed
      • Austin, Texas, United States, 78750
        • Altana Pharma/Nycomed
      • Dallas, Texas, United States, 75231
        • Altana Pharma/Nycomed
      • El Paso, Texas, United States, 79925
        • Altana Pharma/Nycomed
      • Kerrville, Texas, United States, 78028
        • Altana Pharma/Nycomed
      • New Braunfels, Texas, United States, 78130
        • Altana Pharma/Nycomed
      • San Antonio, Texas, United States, 78229
        • 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
      • Charlottesville, Virginia, United States, 22911
        • Altana Pharma/Nycomed
      • Richmond, Virginia, United States, 23226
        • Altana Pharma/Nycomed
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • 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:

  • 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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Average of morning and evening parent/caregiver reported reflective total nasal symptoms score over the two weeks of treatment

Secondary Outcome Measures

Outcome Measure
safety
Physician assessment of nasal symptoms score at endpoint
average of morning and evening parent/caregiver reported instantaneous total nasal symptom score over the two weeks of treatment

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

March 1, 2006

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

March 21, 2006

First Submitted That Met QC Criteria

March 21, 2006

First Posted (Estimate)

March 22, 2006

Study Record Updates

Last Update Posted (Estimate)

November 30, 2016

Last Update Submitted That Met QC Criteria

November 29, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BY9010/M1-417

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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