| Primary | Change From Baseline in Average Daily Subject Reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind 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 two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. | n = number of ITT subjects in treatmentgroup with completed assessment | Posted | | Least Squares Mean | Standard Error | units on a scale | | Weeks 0 - 2 | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo: Placebo - one actuation per nostril | | OG001 | Ciclesonide Nasal Aerosol 37mcg | ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg | | OG002 | Ciclesonide Nasal Aerosol 74 mcg | ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.63± 0.133
- OG001-1.73± 0.133
- OG002-1.61± 0.133
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| Secondary | Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind 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 two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. | n = number of ITT subjects in treatment group with completed assessment | Posted | | Least Squares Mean | Standard Error | units on a scale | | Weeks 0 - 2 | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo: Placebo - one actuation per nostril | | OG001 | Ciclesonide Nasal Aerosol 37mcg | ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg | | OG002 | Ciclesonide Nasal Aerosol 74 mcg | ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg |
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| Secondary | Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Ocular Symptom Scores (rTOSS) Over the 2-week Double-blind Treatment Period. | TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent
- = mild
- = moderate
- = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
| n = number of ITT subjects in treatment group with completed assessment | Posted | | Least Squares Mean | Standard Error | units on a scale | | Weeks 0 - 2 | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo: Placebo - one actuation per nostril | | OG001 | Ciclesonide Nasal Aerosol 37mcg | ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg | | OG002 | Ciclesonide Nasal Aerosol 74 mcg | ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg |
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| Secondary | Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the Double-blind Treatment Period. | PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses and the individual domain scores are the means of the items in those domains. | n = number of ITT subjects in treatment group with completed assessment | Posted | | Least Squares Mean | Standard Error | units on a scale | | Weeks 0 - 2 | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo: Placebo - one actuation per nostril | | OG001 | Ciclesonide Nasal Aerosol 37mcg | ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg | | OG002 | Ciclesonide Nasal Aerosol 74 mcg | |
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| Secondary | Change From Baseline in Average Daily Subject Reported AM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions assessed in the AM. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe in the AM. 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 two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. | n = number of ITT subjects in treatment group with completed assessment | Posted | | Least Squares Mean | Standard Error | units on a scale | | Weeks 0 - 2 | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo: Placebo - one actuation per nostril | | OG001 | Ciclesonide Nasal Aerosol 37mcg | ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg | | OG002 | Ciclesonide Nasal Aerosol 74 mcg | |
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| Secondary | Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Ocular Symptom Scores (iTOSS) Over the 2-week Double-blind Treatment Period. | TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent
- = mild
- = moderate
- = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement
| n = number of ITT subjects in treatment group with completed assessment | Posted | | Least Squares Mean | Standard Error | units on a scale | | Weeks 0 - 2 | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo: Placebo - one actuation per nostril | | OG001 | Ciclesonide Nasal Aerosol 37mcg | ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg | | OG002 | Ciclesonide Nasal Aerosol 74 mcg | ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg |
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| Secondary | Time to Maximal Effect in the AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period | The time to maximal effect, defined as the number of days until the first treatment day on which the estimated difference between ciclesonide nasal aerosol and placebo was at least 90% of the largest estimated difference, was based on the analyses of change from baseline in the average of AM and PM rTNSS scores for each day. The time to achieve at least 90% of these estimated differences is presented. | | Posted | | Number | | Days | | Weeks 0 - 2 | | | | ID | Title | Description |
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| OG000 | Ciclesonide Nasal Aerosol 37mcg | ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg | | OG001 | Ciclesonide Nasal Aerosol 74 mcg | ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg |
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| Secondary | Number of Subjects Experiencing Treatment-emergent AEs | Treatment-Emergent Adverse Events Occurring in ≥ 2% of Subjects in Any Treatment Group (ITT Population) | | Posted | | Number | | participants | | Weeks 0 - 3 | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo: Placebo - one actuation per nostril | | OG001 | Ciclesonide Nasal Aerosol 37mcg | ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg | | OG002 | Ciclesonide Nasal Aerosol 74 mcg | ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg |
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| Secondary | Percentage of Subjects Experiencing Treatment-emergent AEs | Treatment-Emergent Adverse Events Occurring in ≥ 2% of Subjects in Any Treatment Group (ITT Population) | | Posted | | Number | | Percentage of participants | | Weeks 0 - 3 | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo: Placebo - one actuation per nostril | | OG001 | Ciclesonide Nasal Aerosol 37mcg | ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg | | OG002 | Ciclesonide Nasal Aerosol 74 mcg | ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg |
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| Secondary | Treatment-emergent AEs Causing Study Medication Discontinuation | | | Posted | | Number | | participants | | Weeks 0 - 3 | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo: Placebo - one actuation per nostril | | OG001 | Ciclesonide Nasal Aerosol 37mcg | ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg | | OG002 | Ciclesonide Nasal Aerosol 74 mcg | ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg |
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| Secondary | Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | | | Posted | | Number | | participants | | Weeks 0 - 3 | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo: Placebo - one actuation per nostril | | OG001 | Ciclesonide Nasal Aerosol 37mcg | ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg | | OG002 | Ciclesonide Nasal Aerosol 74 mcg | ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg |
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| Secondary | Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | | | Posted | | Number | | Percentage of participants | | Weeks 0 - 3 | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo: Placebo - one actuation per nostril | | OG001 | Ciclesonide Nasal Aerosol 37mcg | ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg | | OG002 | Ciclesonide Nasal Aerosol 74 mcg | ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg |
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