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

Completed · Phase 3

Conditions studied: Perennial Allergic Rhinitis

In brief

6-month safety extension study in subjects who have completed Study 060-633 (NCT00953147). Evaluating the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered once-daily in patients with Perennial Allergic Rhinitis.

Key facts

Study ID

NCT01067105

Run by

Sumitomo Pharma America, Inc.

People needed

824

Starts

2010-02-01

Expected to finish

2010-11-01

Last updated by the study team

2012-06-13

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has successfully completed all visits of Study 060-633.
• 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:
• 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.
• Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
• Abstinence.

You may not qualify if…

• Female subject who is pregnant or lactating.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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