Perennial Allergic Rhinitis
Conditions
Keywords
Perennial allergic rhinitis, allergic rhinitis, ciclesonide
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.
Interventions
ciclesonide HFA 160 μg once daily
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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: 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
* 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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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 |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ciclesonide ciclesonide HFA 160 μg once daily | 824 |
| Total | 824 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 14 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Other | 31 |
| Overall Study | Physician Decision | 6 |
| Overall Study | Protocol Violation | 48 |
| Overall Study | Withdrawal by Subject | 36 |
Baseline characteristics
| Characteristic | Ciclesonide |
|---|---|
| Age, Categorical <=18 years | 64 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 743 Participants |
| Age Continuous | 38.5 years STANDARD_DEVIATION 13.2 |
| Baseline AM Instantaneous Total Nasal Symptom Score (iTNSS) | 5.12 units on a scale STANDARD_DEVIATION 3.05 |
| Baseline AM Reflective Total Nasal Symptom Score (rTNSS) | 5.66 units on a scale STANDARD_DEVIATION 3.07 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 160 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 664 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity American Indian or Alaska Native | 1 participants |
| Race/Ethnicity Asian | 15 participants |
| Race/Ethnicity Black or African American | 104 participants |
| Race/Ethnicity Multiple | 4 participants |
| Race/Ethnicity Native Hawaiian or Other Pacific Islander | 3 participants |
| Race/Ethnicity Other | 7 participants |
| Race/Ethnicity White/Caucasian | 690 participants |
| Sex: Female, Male Female | 529 Participants |
| Sex: Female, Male Male | 295 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 329 / 824 |
| serious Total, serious adverse events | 15 / 824 |
Outcome results
Primary
Percentage of Subjects Experiencing Adverse Events (AEs)
Time frame: Weeks 1-26
Population: Intent to Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide | Percentage of Subjects Experiencing Adverse Events (AEs) | 51.5 percentage of participants |
Primary
Percentage of Subjects Experiencing Serious Adverse Events (SAEs)
Time frame: Weeks 1-26
Population: Intent to Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide | Percentage of Subjects Experiencing Serious Adverse Events (SAEs) | 1.8 percentage of participants |
Primary
Percentage of Subjects Who Discontinue Due to AEs.
Time frame: Weeks 1-26
Population: Intent to Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide | Percentage of Subjects Who Discontinue Due to AEs. | 1.7 percentage of participants |
Secondary
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 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.
Time frame: Baseline and Months 1, 2, 3, 4, 5, 6
Population: Intent to Treat Population. Subjects with missing date were not included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide | Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period. | Month 1 (n=823) | -0.26 units on a scale | Standard Deviation 1.16 |
| Ciclesonide | Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period. | Month 2 (n=806) | -0.55 units on a scale | Standard Deviation 1.41 |
| Ciclesonide | Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period. | Month 3 (n=768) | -0.66 units on a scale | Standard Deviation 1.47 |
| Ciclesonide | Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period. | Month 4 (n=743) | -0.70 units on a scale | Standard Deviation 1.57 |
| Ciclesonide | Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period. | Month 5 (n=716) | -0.67 units on a scale | Standard Deviation 1.68 |
| Ciclesonide | Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period. | Month 6 (n=697) | -0.57 units on a scale | Standard Deviation 1.73 |
Secondary
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 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.
Time frame: Baseline and Weeks 1-26
Population: Intent to Treat Population. Subjects with missing date were not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide | Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period. | -0.54 units on a scale | Standard Deviation 1.37 |
Secondary
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 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.
Time frame: Baseline and Months 1, 2, 3, 4, 5, and 6
Population: Intent to Treat Population. Subjects with missing date were not included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide | Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period. | Month 1 (n=823) | -0.18 units on a scale | Standard Deviation 1.26 |
| Ciclesonide | Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period. | Month 2 (n=806) | -0.48 units on a scale | Standard Deviation 1.49 |
| Ciclesonide | Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period. | Month 3 (n=768) | -0.64 units on a scale | Standard Deviation 1.57 |
| Ciclesonide | Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period. | Month 4 (n=743) | -0.69 units on a scale | Standard Deviation 1.7 |
| Ciclesonide | Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period. | Month 5 (n=716) | -0.64 units on a scale | Standard Deviation 1.77 |
| Ciclesonide | Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period. | Month 6 (n=697) | -0.54 units on a scale | Standard Deviation 1.87 |
Secondary
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 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.
Time frame: Baseline and Weeks 1-26
Population: Intent to Treat Population. Subjects with missing date were not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide | Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period. | -0.50 units on a scale | Standard Deviation 1.46 |
Secondary
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
Time frame: Weeks 0-6 and 6-12
Population: Intent to Treat Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ciclesonide | Number of Devices With Actuation Consistency | Week 0-6 | 556 devices |
| Ciclesonide | Number of Devices With Actuation Consistency | Week 6-12 | 531 devices |
Secondary
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
Time frame: Weeks 0-6 and 6-12
Population: Intent to Treat Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ciclesonide | Number of Devices With Major Discrepancies | Week 0-6 | 144 devices |
| Ciclesonide | Number of Devices With Major Discrepancies | Week 6-12 | 117 devices |
Secondary
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.
Time frame: Weeks 6 and 12
Population: Intent to Treat Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ciclesonide | Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey | Week 6 | 794 participants |
| Ciclesonide | Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey | Week 12 | 744 participants |
Secondary
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
Time frame: Weeks 0-6 and 6-12
Population: Intent to Treat Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ciclesonide | Percentage of Devices With Actuation Consistency | Week 0-6 | 71.5 percentage of devices |
| Ciclesonide | Percentage of Devices With Actuation Consistency | Week 6-12 | 72.5 percentage of devices |
Secondary
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
Time frame: Weeks 0-6 and 6-12
Population: Intent to Treat Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ciclesonide | Percentage of Devices With Major Discrepancies | Week 0-6 | 18.5 percentage of devices |
| Ciclesonide | Percentage of Devices With Major Discrepancies | Week 6-12 | 16.0 percentage of devices |
Secondary
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.
Time frame: Weeks 1-26
Population: Intent to Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide | Percentage of Subjects Experiencing Local Nasal AEs | 29.4 percentage of participants |
Secondary
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.
Time frame: Weeks 0-12
Population: Intent to Treat Population. Subjects with missing dosing indicator data were excluded from these analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide | Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances | Week 0-6 (n=778) | 112.29 percentage of correct advances | Standard Deviation 23.64 |
| Ciclesonide | Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances | Week 6-12 (n=732) | 112.23 percentage of correct advances | Standard Deviation 23.72 |