Safety and Effectiveness of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis During One Year Treatment (BY9010/M1-404)

NCT ID: NCT00163501

Last Updated: 2016-11-30

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

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2005-04-30

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

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

Exclusion Criteria

* Participation in any investigational drug trial within the 30 days preceding the Screening Visit
* A known hypersensitivity to any corticosteroid or any of the excipients in the formulation
* Use of any prohibited concomitant medications as defined by the study protocol
Minimum Eligible Age

12 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

Encinitas, California, United States

Site Status

Altana Pharma/Nycomed

Huntington Beach, California, United States

Site Status

Altana Pharma/Nycomed

Long Beach, California, United States

Site Status

Altana Pharma/Nycomed

Los Angeles, California, United States

Site Status

Altana Pharma/Nycomed

Mission Viejo, California, United States

Site Status

Altana Pharma/Nycomed

Newport Beach, California, United States

Site Status

Altana Pharma/Nycomed

San Diego, California, United States

Site Status

Altana Pharma/Nycomed

San Diego, California, United States

Site Status

Altana Pharma/Nycomed

Stockton, California, United States

Site Status

Altana Pharma/Nycomed

Vista, California, United States

Site Status

Altana Pharma/Nycomed

Trumbull, Connecticut, United States

Site Status

Altana Pharma/Nycomed

Clearwater, Florida, United States

Site Status

Altana Pharma/Nycomed

DeLand, Florida, United States

Site Status

Altana Pharma/Nycomed

Atlanta, Georgia, United States

Site Status

Altana Pharma/Nycomed

Normal, Illinois, United States

Site Status

Altana Pharma/Nycomed

Overland Park, Kansas, United States

Site Status

Altana Pharma/Nycomed

New Orleans, Louisiana, United States

Site Status

Altana Pharma/Nycomed

Bethesda, Maryland, United States

Site Status

Altana Pharma/Nycomed

North Dartmouth, Massachusetts, United States

Site Status

Altana Pharma/Nycomed

Forked River, New Jersey, United States

Site Status

Altana Pharma/Nycomed

Skillman, New Jersey, United States

Site Status

Altana Pharma/Nycomed

Springfield, New Jersey, United States

Site Status

Altana Pharma/Nycomed

Liverpool, New York, United States

Site Status

Altana Pharma/Nycomed

Raleigh, North Carolina, United States

Site Status

Altana Pharma/Nycomed

Winston-Salem, North Carolina, United States

Site Status

Altana Pharma/Nycomed

Cincinnati, Ohio, United States

Site Status

Altana Pharma/Nycomed

Cincinnati, Ohio, United States

Site Status

Altana Pharma/Nycomed

Oklahoma City, Oklahoma, United States

Site Status

Altana Pharma/Nycomed

Portland, Oregon, United States

Site Status

Altana Pharma/Nycomed

Easton, Pennsylvania, United States

Site Status

Altana Pharma/Nycomed

Pittsburgh, Pennsylvania, United States

Site Status

Altana Pharma/Nycomed

Cranston, Rhode Island, United States

Site Status

Altana Pharma/Nycomed

Austin, Texas, United States

Site Status

Altana Pharma/Nycomed

Dallas, Texas, United States

Site Status

Altana Pharma/Nycomed

Houston, Texas, United States

Site Status

Altana Pharma/Nycomed

Kerrville, Texas, United States

Site Status

Altana Pharma/Nycomed

New Braunfels, Texas, United States

Site Status

Altana Pharma/Nycomed

San Antonio, Texas, United States

Site Status

Altana Pharma/Nycomed

Salt Lake City, Utah, United States

Site Status

Altana Pharma/Nycomed

Richmond, Virginia, United States

Site Status

Altana Pharma/Nycomed

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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BY9010/M1-404

Identifier Type: -

Identifier Source: org_study_id

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