A 6 Month Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
NCT ID: NCT01067105
Last Updated: 2012-06-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
824 participants
INTERVENTIONAL
2010-02-28
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ciclesonide
ciclesonide HFA 160 μg once daily
ciclesonide HFA 160 μg
ciclesonide HFA 160 μg once daily
Interventions
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ciclesonide HFA 160 μg
ciclesonide HFA 160 μg once daily
Eligibility Criteria
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Inclusion Criteria
* Subject has given written informed consent and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
* Subject is male or female 12 years and older.
* Subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on screening physical examination, clinical laboratory tests, and medical history.
* Subject, if female 65 years of age or younger, must have a negative urine pregnancy test (performed at Visit 1). Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control:
1. An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation.
2. Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
3. Abstinence.
Exclusion Criteria
* History of physical findings of nasal pathology, including nasal polyps.
* Subject has any condition that, in the judgment of the investigator, would preclude the subject from completing the study.
12 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Locations
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Allergy and Asthma Specialists Group
Huntington Beach, California, United States
California Allergy and Asthma Medical Group
Los Angeles, California, United States
Southern California Research
Mission Viejo, California, United States
CHOC PSF, AMC, Division of Allergy Asthma and Immunology
Orange, California, United States
California Allergy and Asthma Medical Group
Palmdale, California, United States
Allergy Associates Medical Group
San Diego, California, United States
Bensch Research Associates
Stockton, California, United States
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, United States
Storms Clinical Research Institute
Colorado Springs, Colorado, United States
Colorado Allergy and Asthma Centers
Denver, Colorado, United States
DataQuest Medical Research
Lawrenceville, Georgia, United States
Allergy and Asthma Consultants
Lilburn, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Atlanta Allergy and Asthma Clinic
Woodstock, Georgia, United States
Clinical Research Center of Indiana
Indianapolis, Indiana, United States
GR
Bethesda, Maryland, United States
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, United States
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan, United States
The Clinical Research Center
St Louis, Missouri, United States
Clinical Research Group of Montana
Bozeman, Montana, United States
Allergy and Asthma Center of NC
High Point, North Carolina, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
Toledo Center for Clinical Research
Sylvania, Ohio, United States
Allergy and Ashtma Research Group
Eugene, Oregon, United States
Baker Allergy, Asthma, and Dermatology Research Center
Lake Oswego, Oregon, United States
Allergy Associates Research Center
Portland, Oregon, United States
Valley Clinical Research
Bethlehem, Pennsylvania, United States
Asthma and Allergy Research
Upland, Pennsylvania, United States
Asthma, Nasal Disease, and Allergy Research Center of New England
Providence, Rhode Island, United States
National Allergy, Asthma, and Urticaria Centers
Charleston, South Carolina, United States
ISIS Clinical Research
Austin, Texas, United States
Sirius Clinical Research
Austin, Texas, United States
TTS Research
Boerne, Texas, United States
Pharmaceutical Research and Consulting
Dallas, Texas, United States
North Texas Institute for Clinical Trials
Fort Worth, Texas, United States
Allergy and Asthma Associates
Houston, Texas, United States
Kerrville Research Associates
Kerrville, Texas, United States
Central Texas Health Research
New Braunfels, Texas, United States
Western Sky Medical Research
Paso, Texas, United States
Biogenics Research Institute
San Antonio, Texas, United States
Southwest Allergy and Asthma Center
San Antonio, Texas, United States
Sylvana Research
San Antonio, Texas, United States
ASTHMA Inc.
Seattle, Washington, United States
Countries
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Other Identifiers
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060-635
Identifier Type: -
Identifier Source: org_study_id
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