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
- Registration Number
- NCT01067105
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Brief Summary
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.
- Detailed Description
This is a 6-month multi-center, open-label, long-term safety extension study in subjects who have completed Study 060-633 (NCT00953147). This study is designed to evaluate the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered once-daily to male and female subjects 12 years or older diagnosed with perennial allergic rhinitis (PAR). This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 824
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Subject has successfully completed all visits of Study 060-633.
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Subject has given written informed consent and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
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Subject is male or female 12 years and older.
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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.
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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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ciclesonide ciclesonide HFA 160 μg ciclesonide HFA 160 μg once daily
- Primary Outcome Measures
Name Time Method Percentage of Subjects Experiencing Adverse Events (AEs) Weeks 1-26 Percentage of Subjects Experiencing Serious Adverse Events (SAEs) Weeks 1-26 Percentage of Subjects Who Discontinue Due to AEs. Weeks 1-26
- Secondary Outcome Measures
Name Time Method Percentage of Subjects Experiencing Local Nasal AEs Weeks 1-26 Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.
Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period. Baseline and Weeks 1-26 TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
1. = mild
2. = moderate
3. = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the 6-month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period. Baseline and Weeks 1-26 TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
1. = mild
2. = moderate
3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period. Baseline and Months 1, 2, 3, 4, 5, and 6 TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
1. = mild
2. = moderate
3. = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period. Baseline and Months 1, 2, 3, 4, 5, 6 TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:
0 = absent
1. = mild
2. = moderate
3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances Weeks 0-12 Ratio of correct advance is defined as the (number of doses actuated/number of doses reported) \* 100% and therefore reported as a percentage.
Number of Devices With Actuation Consistency Weeks 0-6 and 6-12 Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration
Percentage of Devices With Actuation Consistency Weeks 0-6 and 6-12 Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration
Number of Devices With Major Discrepancies Weeks 0-6 and 6-12 A major discrepancy is defined as a discrepancy of \>20 actuations between the dose indicator and subject self report of study medication administration
Percentage of Devices With Major Discrepancies Weeks 0-6 and 6-12 A major discrepancy is defined as a discrepancy of \>20 actuations between the dose indicator and subject self report of study medication administration
Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey Weeks 6 and 12 Participants responding to a survey that consisted of 7 questions assessing subject satisfaction with the dose indicator.
Trial Locations
- Locations (42)
Kerrville Research Associates
🇺🇸Kerrville, Texas, United States
Asthma, Nasal Disease, and Allergy Research Center of New England
🇺🇸Providence, Rhode Island, United States
Allergy and Asthma Specialists Group
🇺🇸Huntington Beach, California, United States
California Allergy and Asthma Medical Group
🇺🇸Palmdale, California, United States
CHOC PSF, AMC, Division of Allergy Asthma and Immunology
🇺🇸Orange, California, United States
Southern California Research
🇺🇸Mission Viejo, California, United States
Bensch Research Associates
🇺🇸Stockton, California, United States
Colorado Allergy and Asthma Centers
🇺🇸Denver, Colorado, United States
Allergy Associates Medical Group
🇺🇸San Diego, California, United States
Asthma and Allergy Associates, PC
🇺🇸Colorado Springs, Colorado, United States
Storms Clinical Research Institute
🇺🇸Colorado Springs, Colorado, United States
DataQuest Medical Research
🇺🇸Lawrenceville, Georgia, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
Allergy and Asthma Consultants
🇺🇸Lilburn, Georgia, United States
Atlanta Allergy and Asthma Clinic
🇺🇸Woodstock, Georgia, United States
GR
🇺🇸Bethesda, Maryland, United States
Clinical Research Center of Indiana
🇺🇸Indianapolis, Indiana, United States
Northeast Medical Research Associates, Inc.
🇺🇸North Dartmouth, Massachusetts, United States
Respiratory Medicine Research Institute of Michigan
🇺🇸Ypsilanti, Michigan, United States
Allergy and Asthma Center of NC
🇺🇸High Point, North Carolina, United States
Clinical Research Group of Montana
🇺🇸Bozeman, Montana, United States
The Clinical Research Center
🇺🇸St. Louis, Missouri, United States
North Carolina Clinical Research
🇺🇸Raleigh, North Carolina, United States
Allergy and Ashtma Research Group
🇺🇸Eugene, Oregon, United States
Baker Allergy, Asthma, and Dermatology Research Center
🇺🇸Lake Oswego, Oregon, United States
Toledo Center for Clinical Research
🇺🇸Sylvania, Ohio, United States
Valley Clinical Research
🇺🇸Bethlehem, Pennsylvania, United States
Allergy Associates Research Center
🇺🇸Portland, Oregon, United States
National Allergy, Asthma, and Urticaria Centers
🇺🇸Charleston, South Carolina, United States
Asthma and Allergy Research
🇺🇸Upland, Pennsylvania, United States
Sirius Clinical Research
🇺🇸Austin, Texas, United States
TTS Research
🇺🇸Boerne, Texas, United States
ISIS Clinical Research
🇺🇸Austin, Texas, United States
Pharmaceutical Research and Consulting
🇺🇸Dallas, Texas, United States
Allergy and Asthma Associates
🇺🇸Houston, Texas, United States
North Texas Institute for Clinical Trials
🇺🇸Fort Worth, Texas, United States
Western Sky Medical Research
🇺🇸Paso, Texas, United States
Biogenics Research Institute
🇺🇸San Antonio, Texas, United States
Central Texas Health Research
🇺🇸New Braunfels, Texas, United States
Sylvana Research
🇺🇸San Antonio, Texas, United States
Southwest Allergy and Asthma Center
🇺🇸San Antonio, Texas, United States
ASTHMA Inc.
🇺🇸Seattle, Washington, United States