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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Perennial Allergic Rhinitis

Intervention / Treatment
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* Drug: ciclesonide HFA 160 μg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ciclesonide<br>ciclesonide HFA 160 μg once daily | Drug: ciclesonide HFA 160 μg<br>* ciclesonide HFA 160 μg once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Weeks 1-26 | 
| 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. | Baseline and Weeks 1-26 | 
| 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. | Baseline and Weeks 1-26 | 
| 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. | Baseline and Months 1, 2, 3, 4, 5, and 6 | 
| 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. | Baseline and Months 1, 2, 3, 4, 5, 6 | 
| 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. | Weeks 0-12 | 
| 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 | Weeks 0-6 and 6-12 | 
| 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 | Weeks 0-6 and 6-12 | 
| 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 | Weeks 0-6 and 6-12 | 
| 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 | Weeks 0-6 and 6-12 | 
| 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. | Weeks 6 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perennial allergic rhinitis, allergic rhinitis, ciclesonide