Back to resultsA 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
Primary Purpose
Perennial Allergic Rhinitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ciclesonide HFA 160 μg
Sponsored by
About this trial
This is an interventional treatment trial for Perennial Allergic Rhinitis focused on measuring Perennial allergic rhinitis, allergic rhinitis, ciclesonide
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Allergy and Asthma Specialists Group
- California Allergy and Asthma Medical Group
- Southern California Research
- CHOC PSF, AMC, Division of Allergy Asthma and Immunology
- California Allergy and Asthma Medical Group
- Allergy Associates Medical Group
- Bensch Research Associates
- Asthma and Allergy Associates, PC
- Storms Clinical Research Institute
- Colorado Allergy and Asthma Centers
- DataQuest Medical Research
- Allergy and Asthma Consultants
- Clinical Research Atlanta
- Clinical Research Atlanta
- Atlanta Allergy and Asthma Clinic
- Clinical Research Center of Indiana
- GR
- Northeast Medical Research Associates, Inc.
- Respiratory Medicine Research Institute of Michigan
- The Clinical Research Center
- Clinical Research Group of Montana
- Allergy and Asthma Center of NC
- North Carolina Clinical Research
- Toledo Center for Clinical Research
- Allergy and Ashtma Research Group
- Baker Allergy, Asthma, and Dermatology Research Center
- Allergy Associates Research Center
- Valley Clinical Research
- Asthma and Allergy Research
- Asthma, Nasal Disease, and Allergy Research Center of New England
- National Allergy, Asthma, and Urticaria Centers
- ISIS Clinical Research
- Sirius Clinical Research
- TTS Research
- Pharmaceutical Research and Consulting
- North Texas Institute for Clinical Trials
- Allergy and Asthma Associates
- Kerrville Research Associates
- Central Texas Health Research
- Western Sky Medical Research
- Biogenics Research Institute
- Southwest Allergy and Asthma Center
- Sylvana Research
- ASTHMA Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ciclesonide
Arm Description
ciclesonide HFA 160 μg once daily
Outcomes
Primary Outcome Measures
Percentage of Subjects Experiencing Adverse Events (AEs)
Percentage of Subjects Experiencing Serious Adverse Events (SAEs)
Percentage of Subjects Who Discontinue Due to AEs.
Secondary Outcome Measures
Percentage of Subjects Experiencing Local Nasal AEs
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.
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
= mild
= moderate
= 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.
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
= mild
= moderate
= 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.
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
= mild
= moderate
= 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.
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
= mild
= moderate
= 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
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
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
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
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
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
Participants responding to a survey that consisted of 7 questions assessing subject satisfaction with the dose indicator.
Full Information
NCT ID
NCT01067105
First Posted
February 9, 2010
Last Updated
June 8, 2012
Sponsor
Sumitomo Pharma America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01067105
Brief Title
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
Official Title
A 6-Month Open-Label, Long-Term Safety Extension Study of Once Daily Ciclesonide HFA Nasal Aerosol (160 μg) in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perennial Allergic Rhinitis
Keywords
Perennial allergic rhinitis, allergic rhinitis, ciclesonide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
824 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ciclesonide
Arm Type
Experimental
Arm Description
ciclesonide HFA 160 μg once daily
Intervention Type
Drug
Intervention Name(s)
ciclesonide HFA 160 μg
Intervention Description
ciclesonide HFA 160 μg once daily
Primary Outcome Measure Information:
Title
Percentage of Subjects Experiencing Adverse Events (AEs)
Time Frame
Weeks 1-26
Title
Percentage of Subjects Experiencing Serious Adverse Events (SAEs)
Time Frame
Weeks 1-26
Title
Percentage of Subjects Who Discontinue Due to AEs.
Time Frame
Weeks 1-26
Secondary Outcome Measure Information:
Title
Percentage of Subjects Experiencing Local Nasal AEs
Description
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.
Time Frame
Weeks 1-26
Title
Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period.
Description
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
= mild
= moderate
= 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.
Time Frame
Baseline and Weeks 1-26
Title
Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period.
Description
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
= mild
= moderate
= 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.
Time Frame
Baseline and Weeks 1-26
Title
Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period.
Description
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
= mild
= moderate
= 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.
Time Frame
Baseline and Months 1, 2, 3, 4, 5, and 6
Title
Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period.
Description
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
= mild
= moderate
= 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.
Time Frame
Baseline and Months 1, 2, 3, 4, 5, 6
Title
Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances
Description
Ratio of correct advance is defined as the (number of doses actuated/number of doses reported) * 100% and therefore reported as a percentage.
Time Frame
Weeks 0-12
Title
Number of Devices With Actuation Consistency
Description
Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration
Time Frame
Weeks 0-6 and 6-12
Title
Percentage of Devices With Actuation Consistency
Description
Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration
Time Frame
Weeks 0-6 and 6-12
Title
Number of Devices With Major Discrepancies
Description
A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration
Time Frame
Weeks 0-6 and 6-12
Title
Percentage of Devices With Major Discrepancies
Description
A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration
Time Frame
Weeks 0-6 and 6-12
Title
Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey
Description
Participants responding to a survey that consisted of 7 questions assessing subject satisfaction with the dose indicator.
Time Frame
Weeks 6 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Allergy and Asthma Specialists Group
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
California Allergy and Asthma Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Southern California Research
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
CHOC PSF, AMC, Division of Allergy Asthma and Immunology
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
California Allergy and Asthma Medical Group
City
Palmdale
State/Province
California
ZIP/Postal Code
93551
Country
United States
Facility Name
Allergy Associates Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Bensch Research Associates
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
Asthma and Allergy Associates, PC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Storms Clinical Research Institute
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Colorado Allergy and Asthma Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
DataQuest Medical Research
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Allergy and Asthma Consultants
City
Lilburn
State/Province
Georgia
ZIP/Postal Code
30047
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Atlanta Allergy and Asthma Clinic
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30188
Country
United States
Facility Name
Clinical Research Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46208
Country
United States
Facility Name
GR
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Northeast Medical Research Associates, Inc.
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Respiratory Medicine Research Institute of Michigan
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
The Clinical Research Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Clinical Research Group of Montana
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59718
Country
United States
Facility Name
Allergy and Asthma Center of NC
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
North Carolina Clinical Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Toledo Center for Clinical Research
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Allergy and Ashtma Research Group
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Baker Allergy, Asthma, and Dermatology Research Center
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Allergy Associates Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
977213
Country
United States
Facility Name
Valley Clinical Research
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18020
Country
United States
Facility Name
Asthma and Allergy Research
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
Asthma, Nasal Disease, and Allergy Research Center of New England
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
National Allergy, Asthma, and Urticaria Centers
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
ISIS Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Sirius Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
TTS Research
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
Facility Name
Pharmaceutical Research and Consulting
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
North Texas Institute for Clinical Trials
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Facility Name
Allergy and Asthma Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Kerrville Research Associates
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028
Country
United States
Facility Name
Central Texas Health Research
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Western Sky Medical Research
City
Paso
State/Province
Texas
ZIP/Postal Code
79903
Country
United States
Facility Name
Biogenics Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Southwest Allergy and Asthma Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Sylvana Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
ASTHMA Inc.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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