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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00163501
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : November 30, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief 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.

Condition or disease Intervention/treatment Phase
Perennial Allergic Rhinitis Allergic Rhinitis Hay Fever Drug: Ciclesonide Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial to Assess the Long Term Safety of Ciclesonide, Applied as a Nasal Spray (200 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 12 Years and Older
Study Start Date : December 2003
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Ciclesonide




Primary Outcome Measures :
  1. change in Total Nasal Symptom Scores.

Secondary Outcome Measures :
  1. change in symptoms, quality of life, safety.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • General good health, other than perennial allergic rhinitis
  • History and diagnosis of perennial allergic rhinitis by skin prick test

Main 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163501


Locations
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United States, California
Altana Pharma/Nycomed
Encinitas, California, United States, 92024
Altana Pharma/Nycomed
Huntington Beach, California, United States, 92647
Altana Pharma/Nycomed
Long Beach, California, United States, 90806
Altana Pharma/Nycomed
Los Angeles, California, United States, 90025
Altana Pharma/Nycomed
Mission Viejo, California, United States, 92691
Altana Pharma/Nycomed
Newport Beach, California, United States, 92660
Altana Pharma/Nycomed
San Diego, California, United States, 92103
Altana Pharma/Nycomed
San Diego, California, United States, 92120
Altana Pharma/Nycomed
Stockton, California, United States, 95207
Altana Pharma/Nycomed
Vista, California, United States, 92083
United States, Connecticut
Altana Pharma/Nycomed
Trumbull, Connecticut, United States, 06611
United States, Florida
Altana Pharma/Nycomed
Clearwater, Florida, United States, 33761
Altana Pharma/Nycomed
Deland, Florida, United States, 32720
United States, Georgia
Altana Pharma/Nycomed
Atlanta, Georgia, United States, 30342
United States, Illinois
Altana Pharma/Nycomed
Normal, Illinois, United States, 61761
United States, Kansas
Altana Pharma/Nycomed
Overland Park, Kansas, United States, 66210
United States, Louisiana
Altana Pharma/Nycomed
New Orleans, Louisiana, United States, 70112
United States, Maryland
Altana Pharma/Nycomed
Bethesda, Maryland, United States, 20814
United States, Massachusetts
Altana Pharma/Nycomed
North Dartmouth, Massachusetts, United States, 02747
United States, New Jersey
Altana Pharma/Nycomed
Forked River, New Jersey, United States, 08731
Altana Pharma/Nycomed
Skillman, New Jersey, United States, 08558
Altana Pharma/Nycomed
Springfield, New Jersey, United States, 07081
United States, New York
Altana Pharma/Nycomed
Liverpool, New York, United States, 13088
United States, North Carolina
Altana Pharma/Nycomed
Raleigh, North Carolina, United States, 27607
Altana Pharma/Nycomed
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Altana Pharma/Nycomed
Cincinnati, Ohio, United States, 45219
Altana Pharma/Nycomed
Cincinnati, Ohio, United States, 45246
United States, Oklahoma
Altana Pharma/Nycomed
Oklahoma, Oklahoma, United States, 73104
United States, Oregon
Altana Pharma/Nycomed
Portland, Oregon, United States, 97213
United States, Pennsylvania
Altana Pharma/Nycomed
Easton, Pennsylvania, United States, 18045
Altana Pharma/Nycomed
Pittsburgh, Pennsylvania, United States, 15241
United States, Rhode Island
Altana Pharma/Nycomed
Cranston, Rhode Island, United States, 02920
United States, Texas
Altana Pharma/Nycomed
Austin, Texas, United States, 78731
Altana Pharma/Nycomed
Dallas, Texas, United States, 75231
Altana Pharma/Nycomed
Houston, Texas, United States, 77054
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
United States, Utah
Altana Pharma/Nycomed
Salt Lake City, Utah, United States, 84111
United States, Virginia
Altana Pharma/Nycomed
Richmond, Virginia, United States, 23226
United States, Wisconsin
Altana Pharma/Nycomed
Milwaukee, Wisconsin, United States, 53201
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca AstraZeneca AstraZeneca
Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00163501    
Other Study ID Numbers: BY9010/M1-404
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: October 2016
Keywords provided by AstraZeneca:
Allergy
Perennial Allergic Rhinitis
Allergic Rhinitis
Hay Fever
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ciclesonide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents