Change From Baseline in Daily Subject-reported AM and PM iTNSS Averaged Over the Two-week 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). 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.
Change From Baseline in Daily Subject-reported AM and PM rTOSS Averaged Over the Two-week Treatment Period in Participants With a Baseline rTOSS >= 5.0
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 week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the Two Week 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 two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the Two Week 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 two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the Two Week 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 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.
Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the Two Week 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). 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.
Change From Baseline in Daily Subject-reported AM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0
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 week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Change From Baseline in Daily Subject-reported PM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0
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 week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Change From Baseline in Daily Subject-reported AM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
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 week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Change From Baseline in Daily Subject-reported PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
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 week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Change From Baseline in Daily Subject Reported AM and PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
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 week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week 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
= mild
= moderate
= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week 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
= mild
= moderate
= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week 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
= mild
= moderate
= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week 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
= mild
= moderate
= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week 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
= mild
= moderate
= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week 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
= mild
= moderate
= severe Instantaneous NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0
OSS 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
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS 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.
Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0
OSS 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
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS 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.
Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0
OSS 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
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS 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.
Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
OSS 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
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS 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.
Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
OSS 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
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS 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.
Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
OSS 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
= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS 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.
Change From Baseline in Overall Score of the Rhinoconjunctivitis Quality of Life Questionnaire With Standard Activities (RQLQ(S)) in Participants With a Baseline Overall Score >= 3.0
The RQLQ(S) in impaired subjects (baseline RQLQ[S] score ≥3.0) at baseline and end of week 2. It consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.
Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS)
Onset of nasal improvement was defined as the first assessment at which iTNSS for active treatment demonstrated an improvement over placebo from baseline.
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 12 reflecting more severe symptoms). Instaneous measures these symptoms over the previous 10 minute time interval.
Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0
Onset of improvement iTOSS was defined as the first assessment at which iTOSSS for active treatment demonstrated an improvement over placebo from baseline. 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 9 reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval.
Time to Maximal Effect as Measured by Change From Baseline in the Average AM and PM Reflective Total Nasal Symptoms Scores (rTNSS)
The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between Ciclesonide HFA and 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.