| Primary | Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline | AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE). | Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Mean | Standard Deviation | mcg•h/dL | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | | OG003 | Ciclesonide Aqueous Nasal Spray 200 Mcg | Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily | | OG004 | Placebo Aqueous Nasal Spray | AQ Nasal Spray Placebo once daily |
| | Units | Counts |
|---|
| Participants | - OG00050
- OG00160
- OG00257
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000183.2± 61.9
- OG001171.7± 40.1
- OG002173.1± 53.5
- OG003
|
|
| |
| Secondary | Number of Subjects Experiencing Adverse Events (AEs) | | Intent to Treat Population. | Posted | | Number | | participants | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | | OG003 | Ciclesonide Aqueous Nasal Spray 200 Mcg | Ciclesonide Aqueous Nasal Spray 200 mcg once daily | | OG004 | Placebo Aqueous Nasal Spray | AQ Nasal Spray Placebo once daily |
| |
| Secondary | Percentage of Subjects Experiencing Adverse Events (AEs) | | Intent to Treat Population. | Posted | | Number | | percentage of subjects | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | | OG003 | Ciclesonide Aqueous Nasal Spray 200 Mcg | Ciclesonide Aqueous Nasal Spray 200 mcg once daily | | OG004 | AQ Nasal Spray Placebo | AQ Nasal Spray Placebo once daily |
| |
| Secondary | Number of Subjects Experiencing Serious Adverse Events (SAEs). | | Intent to Treat Population. | Posted | | Number | | participants | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | | OG003 | Ciclesonide Aqueous Nasal Spray 200 Mcg | Ciclesonide Aqueous Nasal Spray 200 mcg once daily | | OG004 | AQ Nasal Spray Placebo | AQ Nasal Spray Placebo once daily |
| |
| Secondary | Percentage of Subjects Experiencing Serious Adverse Events (SAEs). | | Intent to Treat Population | Posted | | Number | | percentage of subjects | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | | OG003 | Ciclesonide Aqueous Nasal Spray 200 Mcg | Ciclesonide Aqueous Nasal Spray 200 mcg once daily | | OG004 | AQ Nasal Spray Placebo | AQ Nasal Spray Placebo once daily |
| |
| Secondary | Number of Subjects Who Discontinue Due to AEs | | Intent to Treat Population. | Posted | | Number | | participants | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | | OG003 | Ciclesonide Aqueous Nasal Spray 200 Mcg | Ciclesonide Aqueous Nasal Spray 200 mcg once daily | | OG004 | AQ Nasal Spray Placebo | AQ Nasal Spray Placebo once daily |
| |
| Secondary | Percentage of Subjects Who Discontinue Due to AEs | | Intent to Treat Population | Posted | | Number | | percentage of subjects | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | | OG003 | Ciclesonide Aqueous Nasal Spray 200 Mcg | Ciclesonide Aqueous Nasal Spray 200 mcg once daily | | OG004 | AQ Nasal Spray Placebo | AQ Nasal Spray Placebo once daily |
| |
| Secondary | Number 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. | Intent to Treat Population | Posted | | Number | | participants | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | | OG003 | Ciclesonide Aqueous Nasal Spray 200 Mcg | Ciclesonide Aqueous Nasal Spray 200 mcg once daily | | OG004 | AQ Nasal Spray Placebo | |
|
| 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. | Intent to Treat Population | Posted | | Number | | percentage of subjects | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | | OG003 | Ciclesonide Aqueous Nasal Spray 200 Mcg | Ciclesonide Aqueous Nasal Spray 200 mcg once daily | | OG004 | AQ Nasal Spray Placebo | |
|
| Secondary | Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline | | Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Mean | Standard Deviation | mcg•h/dL | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | | OG003 | Ciclesonide Aqueous Nasal Spray 200 Mcg | Ciclesonide Aqueous Nasal Spray 200 mcg once daily | | OG004 | AQ Nasal Spray Placebo | AQ Nasal Spray Placebo once daily |
|
| Secondary | Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment | | Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Least Squares Mean | Standard Error | mcg•h/dL | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | | OG003 | Ciclesonide Aqueous Nasal Spray 200 Mcg | Ciclesonide Aqueous Nasal Spray 200 mcg once daily | | OG004 | AQ Nasal Spray Placebo | AQ Nasal Spray Placebo once daily |
|
| Secondary | Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline | | Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Mean | Standard Deviation | mcg•h/dL | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | | OG003 | Ciclesonide Aqueous Nasal Spray 200 Mcg | Ciclesonide Aqueous Nasal Spray 200 mcg once daily | | OG004 | AQ Nasal Spray Placebo | AQ Nasal Spray Placebo once daily |
|
| Secondary | Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment | | Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Least Squares Mean | Standard Error | mcg•h/dL | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | | OG003 | Ciclesonide Aqueous Nasal Spray 200 Mcg | Ciclesonide Aqueous Nasal Spray 200 mcg once daily | | OG004 | AQ Nasal Spray Placebo | AQ Nasal Spray Placebo once daily |
|
| Secondary | Baseline Daily Subject-reported AM Reflective TNSS | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | |
|
| Secondary | Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily |
|
| Secondary | Baseline Daily Subject-reported PM Reflective TNSS | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | |
|
| Secondary | Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily |
|
| Secondary | Baseline Daily Subject-reported AM Instantaneous TNSS | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | |
|
| Secondary | Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily |
|
| Secondary | Baseline Daily Subject-reported AM and PM Reflective TNSS | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | |
|
| Secondary | Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over Each Week, and Averaged Over the 6 Weeks of Double-blind Treatment | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily |
|
| Secondary | Baseline Daily Subject-reported PM Instantaneous TNSS | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | |
|
| Secondary | Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily |
|
| Secondary | Baseline Daily Subject-reported AM and PM Instantaneous TNSS | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | |
|
| Secondary | Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily |
|
| Secondary | Baseline Daily Subject-reported Individual AM Reflective NSS | NSS is the assessment of the 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 (no sign/symptom evident);
- = mild
- = moderate
- = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | | OG003 | Ciclesonide Aqueous Nasal Spray 200 Mcg |
|
| Secondary | Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | NSS is the assessment of the 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 (no sign/symptom evident);
- = mild
- = moderate
- = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | |
|
| Secondary | Baseline Daily Subject-reported Individual PM Reflective NSS | NSS is the assessment of the 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 (no sign/symptom evident);
- = mild
- = moderate
- = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | | OG003 | Ciclesonide Aqueous Nasal Spray 200 Mcg |
|
| Primary | The Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) From Baseline to Week 6 of the Double Blind Treatment Period | Change is calculated as week 6 minus baseline. AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE). | Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Least Squares Mean | Standard Error | mcg•h/dL | | week 6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | |
|
| Secondary | Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | NSS is the assessment of the 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 (no sign/symptom evident);
- = mild
- = moderate
- = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | |
|
| Secondary | Baseline Daily Subject-reported Individual AM and PM Reflective NSS | NSS is the assessment of the 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 (no sign/symptom evident);
- = mild
- = moderate
- = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | | OG003 | Ciclesonide Aqueous Nasal Spray 200 Mcg |
|
| Secondary | Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | NSS is the assessment of the 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 (no sign/symptom evident);
- = mild
- = moderate
- = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | |
|
| Secondary | Baseline Daily Subject-reported Individual AM Instantaneous NSS | NSS is the assessment of the 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 (no sign/symptom evident);
- = mild
- = moderate
- = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | | OG003 | Ciclesonide Aqueous Nasal Spray 200 Mcg |
|
| Secondary | Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | NSS is the assessment of the 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 (no sign/symptom evident);
- = mild
- = moderate
- = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | |
|
| Secondary | Baseline Daily Subject-reported Individual PM Instantaneous NSS | NSS is the assessment of the 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 (no sign/symptom evident);
- = mild
- = moderate
- = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | | OG003 | Ciclesonide Aqueous Nasal Spray 200 Mcg |
|
| Secondary | Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | NSS is the assessment of the 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 (no sign/symptom evident);
- = mild
- = moderate
- = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | |
|
| Secondary | Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS | NSS is the assessment of the 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 (no sign/symptom evident);
- = mild
- = moderate
- = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | | OG003 |
|
| Secondary | Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | NSS is the assessment of the 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 (no sign/symptom evident);
- = mild
- = moderate
- = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
| Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily | |
|
| Secondary | Time to Maximal Effect Over 6 Weeks of Double-blind Treatment. | The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between each active treatment group and corresponding placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The evaluation is made separately for each dose level of Ciclesonide HFA compared to placebo. Difference is calculated as placebo - ciclesonide. Analysis of HFA data and AQ data were conducted separately. | Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period. | Posted | | Number | | Number of days | | Weeks 0-6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | Ciclesonide Aqueous Nasal Spray 200 Mcg | Ciclesonide Aqueous Nasal Spray 200 mcg once daily |
| |
| Secondary | Ratio (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 dose reported). | Intent to Treat Population | Posted | | Mean | Standard Deviation | percentage of correct advances | | Weeks 1-2, 2-4 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily |
| |
| 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. | Intent to Treat Population | Posted | | Number | | Devices | | Weeks 1-4 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | Ciclesonide Aqueous Nasal Spray 200 Mcg | Ciclesonide Aqueous Nasal Spray 200 mcg once daily |
| |
| 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. | Intent to Treat Population | Posted | | Number | | percentage of devices | | Weeks 1-4 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily |
| |
| 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. | Intent to Treat Population | Posted | | Number | | Devices | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | Ciclesonide Aqueous Nasal Spray 200 Mcg | Ciclesonide Aqueous Nasal Spray 200 mcg once daily |
| |
| 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. | Intent to Treat Population | Posted | | Number | | percentage of devices | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Ciclesonide HFA Nasal Aerosol 320 mcg once daily | | OG001 | Ciclesonide HFA Nasal Aerosol 160 Mcg | Ciclesonide HFA Nasal Aerosol 160 mcg once daily | | OG002 | HFA Nasal Aerosol Placebo | HFA Nasal Aerosol Placebo once daily |
| |