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

NCT ID: NCT00163514

Last Updated: 2016-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

636 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Perennial Allergic Rhinitis Allergic Rhinitis Hay Fever

Keywords

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Allergy Perennial Allergic Rhinitis Allergic Rhinitis Hay Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Ciclesonide

Intervention Type DRUG

Eligibility Criteria

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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.)

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AstraZeneca AstraZeneca

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Altana Pharma/Nycomed

Oxford, Alabama, United States

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Altana Pharma/Nycomed

Huntington Beach, California, United States

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Altana Pharma/Nycomed

Mission Viejo, California, United States

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Altana Pharma/Nycomed

Newport Beach, California, United States

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Altana Pharma/Nycomed

Orange, California, United States

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Altana Pharma/Nycomed

Palmdale, California, United States

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Altana Pharma/Nycomed

San Diego, California, United States

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Altana Pharma/Nycomed

San Diego, California, United States

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Altana Pharma/Nycomed

San Jose, California, United States

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Altana Pharma/Nycomed

Stockton, California, United States

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Altana Pharma/Nycomed

Walnut Creek, CA, California, United States

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Altana Pharma/Nycomed

Coral Gables, Florida, United States

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Altana Pharma/Nycomed

Ocala, Florida, United States

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Altana Pharma/Nycomed

Atlanta, Georgia, United States

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Altana Pharma/Nycomed

Gainesville, Georgia, United States

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Altana Pharma/Nycomed

Savannah, Georgia, United States

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Altana Pharma/Nycomed

Normal, Illinois, United States

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Altana Pharma/Nycomed

Indianapolis, Indiana, United States

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Altana Pharma/Nycomed

Dubuque, Iowa, United States

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Altana Pharma/Nycomed

Overland Park, Kansas, United States

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Altana Pharma/Nycomed

Metairie, Louisiana, United States

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Altana Pharma/Nycomed

Shreveport, Louisiana, United States

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Altana Pharma/Nycomed

Rockville, Maryland, United States

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Altana Pharma/Nycomed

Wheaton, Maryland, United States

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Altana Pharma/Nycomed

North Dartmouth, Massachusetts, United States

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Altana Pharma/Nycomed

Minneapolis, Minnesota, United States

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Altana Pharma/Nycomed

Jefferson City, Missouri, United States

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Altana Pharma/Nycomed

Rolla, Mo, Missouri, United States

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Altana Pharma/Nycomed

St Louis, Missouri, United States

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Altana Pharma/Nycomed

Papillion, Nebraska, United States

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Altana Pharma/Nycomed

Brick, New Jersey, United States

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Altana Pharma/Nycomed

Skillman, New Jersey, United States

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Altana Pharma/Nycomed

Liverpool, New York, United States

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Altana Pharma/Nycomed

Raleigh, North Carolina, United States

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Altana Pharma/Nycomed

Canton, Ohio, United States

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Altana Pharma/Nycomed

Cincinnati, OH, Ohio, United States

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Altana Pharma/Nycomed

Sylvania, Ohio, United States

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Altana Pharma/Nycomed

Medford, Oregon, United States

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Altana Pharma/Nycomed

Portland, Oregon, United States

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Altana Pharma/Nycomed

Easton, Pennsylvania, United States

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Altana Pharma/Nycomed

Hershey, Pennsylvania, United States

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Altana Pharma/Nycomed

Upland, Pennsylvania, United States

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Altana Pharma/Nycomed

Charleston, South Carolina, United States

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Altana Pharma/Nycomed

Charleston, South Carolina, United States

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Altana Pharma/Nycomed

Moncks Corner, South Carolina, United States

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Altana Pharma/Nycomed

Spartanburg, South Carolina, United States

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Altana Pharma/Nycomed

Austin, Texas, United States

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Altana Pharma/Nycomed

El Paso, Texas, United States

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Altana Pharma/Nycomed

Fort Worth, Texas, United States

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Altana Pharma/Nycomed

Friendswood, Texas, United States

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Altana Pharma/Nycomed

Houston, Texas, United States

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Altana Pharma/Nycomed

Katy, Texas, United States

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Altana Pharma/Nycomed

Salt Lake City, Utah, United States

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Altana Pharma/Nycomed

South Burlington, Vermont, United States

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Altana Pharma/Nycomed

Burke, Virginia, United States

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Altana Pharma/Nycomed

Richmond, Virginia, United States

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Altana Pharma/Nycomed

Richmond, Virginia, United States

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Altana Pharma/Nycomed

Spokane, Washington, United States

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Altana Pharma/Nycomed

Hamilton, , Canada

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Altana Pharma/Nycomed

Hamilton, on, , Canada

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Altana Pharma/Nycomed

Kanata, on, , Canada

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Altana Pharma/Nycomed

London, , Canada

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Altana Pharma/Nycomed

London,ON, , Canada

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Altana Pharma/Nycomed

Mississauga, , Canada

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Altana Pharma/Nycomed

Montreal, QC, , Canada

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Altana Pharma/Nycomed

Niagara Falls, , Canada

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Altana Pharma/Nycomed

Oshawa, on, , Canada

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Altana Pharma/Nycomed

Ottawa, , Canada

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Altana Pharma/Nycomed

Ottawa, on, , Canada

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Altana Pharma/Nycomed

Saskatoon,SK, , Canada

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Altana Pharma/Nycomed

Ste-Foy PQ, , Canada

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Altana Pharma/Nycomed

Toronto, , Canada

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Altana Pharma/Nycomed

Toronto, on, , Canada

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Altana Pharma/Nycomed

Winnipeg, , Canada

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Countries

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United States Canada

Related Links

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Other Identifiers

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BY9010/M1-403

Identifier Type: -

Identifier Source: org_study_id