Trial Outcomes & Findings for Clinical Trial to Assess the Efficacy and Safety of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol for the Treatment of Seasonal Allergic Rhinitis (SAR) to Mountain Cedar in Subjects 12 Years and Older (NCT NCT01010971)
NCT ID: NCT01010971
Last Updated: 2012-06-13
Results Overview
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.
COMPLETED
PHASE3
671 participants
Week 0-2
2012-06-13
Participant Flow
Participant milestones
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
80 μg once daily
|
Placebo
Placebo once daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
225
|
226
|
220
|
|
Overall Study
COMPLETED
|
222
|
218
|
207
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
13
|
Reasons for withdrawal
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
80 μg once daily
|
Placebo
Placebo once daily
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
5
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
3
|
|
Overall Study
Other
|
1
|
0
|
2
|
Baseline Characteristics
Clinical Trial to Assess the Efficacy and Safety of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol for the Treatment of Seasonal Allergic Rhinitis (SAR) to Mountain Cedar in Subjects 12 Years and Older
Baseline characteristics by cohort
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=225 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=226 Participants
80 μg once daily
|
Placebo
n=220 Participants
Placebo once daily
|
Total
n=671 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
51 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
198 Participants
n=99 Participants
|
194 Participants
n=107 Participants
|
202 Participants
n=206 Participants
|
594 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
|
Age Continuous
|
40.4 years
STANDARD_DEVIATION 14.4 • n=99 Participants
|
39.8 years
STANDARD_DEVIATION 14.7 • n=107 Participants
|
41.0 years
STANDARD_DEVIATION 13.5 • n=206 Participants
|
40.4 years
STANDARD_DEVIATION 14.2 • n=7 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=99 Participants
|
140 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
398 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
273 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
98 Participants
43.6 • n=99 Participants
|
89 Participants
39.4 • n=107 Participants
|
100 Participants
45.5 • n=206 Participants
|
287 Participants
42.8 • n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
127 Participants
56.4 • n=99 Participants
|
137 Participants
60.6 • n=107 Participants
|
120 Participants
54.5 • n=206 Participants
|
384 Participants
57.2 • n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
207 participants
n=99 Participants
|
191 participants
n=107 Participants
|
191 participants
n=206 Participants
|
589 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
13 participants
n=99 Participants
|
26 participants
n=107 Participants
|
23 participants
n=206 Participants
|
62 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=99 Participants
|
7 participants
n=107 Participants
|
5 participants
n=206 Participants
|
15 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiin or Other Pacific Islander
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Baseline Reflective Total Nasal Symptom Score (rTNSS)
AM
|
9.33 units on a scale
STANDARD_DEVIATION 1.78 • n=99 Participants
|
9.47 units on a scale
STANDARD_DEVIATION 1.80 • n=107 Participants
|
9.34 units on a scale
STANDARD_DEVIATION 1.76 • n=206 Participants
|
9.38 units on a scale
STANDARD_DEVIATION 1.78 • n=7 Participants
|
|
Baseline Reflective Total Nasal Symptom Score (rTNSS)
PM
|
9.20 units on a scale
STANDARD_DEVIATION 1.97 • n=99 Participants
|
9.21 units on a scale
STANDARD_DEVIATION 2.11 • n=107 Participants
|
9.21 units on a scale
STANDARD_DEVIATION 1.92 • n=206 Participants
|
9.21 units on a scale
STANDARD_DEVIATION 2.00 • n=7 Participants
|
|
Baseline Reflective Total Nasal Symptom Score (rTNSS)
AM and PM
|
9.26 units on a scale
STANDARD_DEVIATION 1.80 • n=99 Participants
|
9.34 units on a scale
STANDARD_DEVIATION 1.88 • n=107 Participants
|
9.28 units on a scale
STANDARD_DEVIATION 1.77 • n=206 Participants
|
9.29 units on a scale
STANDARD_DEVIATION 1.82 • n=7 Participants
|
|
Baseline Instantaneous Total Nasal Symptom Score (iTNSS)
AM
|
8.77 units on a scale
STANDARD_DEVIATION 2.10 • n=99 Participants
|
8.73 units on a scale
STANDARD_DEVIATION 2.18 • n=107 Participants
|
8.69 units on a scale
STANDARD_DEVIATION 2.19 • n=206 Participants
|
8.73 units on a scale
STANDARD_DEVIATION 2.15 • n=7 Participants
|
|
Baseline Instantaneous Total Nasal Symptom Score (iTNSS)
PM
|
8.51 units on a scale
STANDARD_DEVIATION 2.29 • n=99 Participants
|
8.49 units on a scale
STANDARD_DEVIATION 2.35 • n=107 Participants
|
8.36 units on a scale
STANDARD_DEVIATION 2.38 • n=206 Participants
|
8.45 units on a scale
STANDARD_DEVIATION 2.34 • n=7 Participants
|
|
Baseline Instantaneous Total Nasal Symptom Score (iTNSS)
AM and PM
|
8.64 units on a scale
STANDARD_DEVIATION 2.14 • n=99 Participants
|
8.60 units on a scale
STANDARD_DEVIATION 2.15 • n=107 Participants
|
8.53 units on a scale
STANDARD_DEVIATION 2.21 • n=206 Participants
|
8.59 units on a scale
STANDARD_DEVIATION 2.16 • n=7 Participants
|
|
Baseline Baseline Reflective Ocular Symptom Score (rTOSS) in Subjects with rTOSS ≥5.0
AM
|
7.09 units on a scale
STANDARD_DEVIATION 1.24 • n=99 Participants
|
7.17 units on a scale
STANDARD_DEVIATION 1.24 • n=107 Participants
|
6.99 units on a scale
STANDARD_DEVIATION 1.21 • n=206 Participants
|
7.09 units on a scale
STANDARD_DEVIATION 1.23 • n=7 Participants
|
|
Baseline Baseline Reflective Ocular Symptom Score (rTOSS) in Subjects with rTOSS ≥5.0
PM
|
7.00 units on a scale
STANDARD_DEVIATION 1.30 • n=99 Participants
|
7.10 units on a scale
STANDARD_DEVIATION 1.25 • n=107 Participants
|
6.94 units on a scale
STANDARD_DEVIATION 1.30 • n=206 Participants
|
7.01 units on a scale
STANDARD_DEVIATION 1.28 • n=7 Participants
|
|
Baseline Baseline Reflective Ocular Symptom Score (rTOSS) in Subjects with rTOSS ≥5.0
AM and PM
|
7.04 units on a scale
STANDARD_DEVIATION 1.22 • n=99 Participants
|
7.13 units on a scale
STANDARD_DEVIATION 1.19 • n=107 Participants
|
6.97 units on a scale
STANDARD_DEVIATION 1.19 • n=206 Participants
|
7.05 units on a scale
STANDARD_DEVIATION 1.20 • n=7 Participants
|
|
Baseline Instantaneous Total Ocular Symtom Score (iTOSS) in Subjects with iTOSS ≥5.0
AM
|
7.07 units on a scale
STANDARD_DEVIATION 1.20 • n=99 Participants
|
7.07 units on a scale
STANDARD_DEVIATION 1.26 • n=107 Participants
|
7.05 units on a scale
STANDARD_DEVIATION 1.14 • n=206 Participants
|
7.06 units on a scale
STANDARD_DEVIATION 1.20 • n=7 Participants
|
|
Baseline Instantaneous Total Ocular Symtom Score (iTOSS) in Subjects with iTOSS ≥5.0
PM
|
6.90 units on a scale
STANDARD_DEVIATION 1.35 • n=99 Participants
|
6.88 units on a scale
STANDARD_DEVIATION 1.39 • n=107 Participants
|
6.92 units on a scale
STANDARD_DEVIATION 1.20 • n=206 Participants
|
6.90 units on a scale
STANDARD_DEVIATION 1.31 • n=7 Participants
|
|
Baseline Instantaneous Total Ocular Symtom Score (iTOSS) in Subjects with iTOSS ≥5.0
AM and PM
|
6.99 units on a scale
STANDARD_DEVIATION 1.21 • n=99 Participants
|
6.97 units on a scale
STANDARD_DEVIATION 1.24 • n=107 Participants
|
6.99 units on a scale
STANDARD_DEVIATION 1.07 • n=206 Participants
|
6.98 units on a scale
STANDARD_DEVIATION 1.17 • n=7 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
AM sneezing
|
2.04 unit on a scale
STANDARD_DEVIATION 0.71 • n=99 Participants
|
2.10 unit on a scale
STANDARD_DEVIATION 0.74 • n=107 Participants
|
2.06 unit on a scale
STANDARD_DEVIATION 0.70 • n=206 Participants
|
2.07 unit on a scale
STANDARD_DEVIATION 0.72 • n=7 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
AM runny nose
|
2.43 unit on a scale
STANDARD_DEVIATION 0.54 • n=99 Participants
|
2.43 unit on a scale
STANDARD_DEVIATION 0.57 • n=107 Participants
|
2.42 unit on a scale
STANDARD_DEVIATION 0.55 • n=206 Participants
|
2.43 unit on a scale
STANDARD_DEVIATION 0.55 • n=7 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
AM nasal itching
|
2.29 unit on a scale
STANDARD_DEVIATION 0.59 • n=99 Participants
|
2.38 unit on a scale
STANDARD_DEVIATION 0.54 • n=107 Participants
|
2.31 unit on a scale
STANDARD_DEVIATION 0.59 • n=206 Participants
|
2.33 unit on a scale
STANDARD_DEVIATION 0.58 • n=7 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
AM nasal congestion
|
2.57 unit on a scale
STANDARD_DEVIATION 0.41 • n=99 Participants
|
2.56 unit on a scale
STANDARD_DEVIATION 0.46 • n=107 Participants
|
2.55 unit on a scale
STANDARD_DEVIATION 0.45 • n=206 Participants
|
2.56 unit on a scale
STANDARD_DEVIATION 0.44 • n=7 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
PM sneezing
|
2.06 unit on a scale
STANDARD_DEVIATION 0.68 • n=99 Participants
|
2.10 unit on a scale
STANDARD_DEVIATION 0.75 • n=107 Participants
|
2.10 unit on a scale
STANDARD_DEVIATION 0.69 • n=206 Participants
|
2.09 unit on a scale
STANDARD_DEVIATION 0.71 • n=7 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
PM runny nose
|
2.40 unit on a scale
STANDARD_DEVIATION 0.59 • n=99 Participants
|
2.34 unit on a scale
STANDARD_DEVIATION 0.63 • n=107 Participants
|
2.35 unit on a scale
STANDARD_DEVIATION 0.59 • n=206 Participants
|
2.36 unit on a scale
STANDARD_DEVIATION 0.60 • n=7 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
PM nasal itching
|
2.27 unit on a scale
STANDARD_DEVIATION 0.62 • n=99 Participants
|
2.30 unit on a scale
STANDARD_DEVIATION 0.60 • n=107 Participants
|
2.27 unit on a scale
STANDARD_DEVIATION 0.60 • n=206 Participants
|
2.28 unit on a scale
STANDARD_DEVIATION 0.60 • n=7 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
PM nasal congestion
|
2.47 unit on a scale
STANDARD_DEVIATION 0.49 • n=99 Participants
|
2.47 unit on a scale
STANDARD_DEVIATION 0.52 • n=107 Participants
|
2.48 unit on a scale
STANDARD_DEVIATION 0.50 • n=206 Participants
|
2.48 unit on a scale
STANDARD_DEVIATION 0.50 • n=7 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
AM and PM sneezing
|
2.05 unit on a scale
STANDARD_DEVIATION 0.66 • n=99 Participants
|
2.10 unit on a scale
STANDARD_DEVIATION 0.72 • n=107 Participants
|
2.08 unit on a scale
STANDARD_DEVIATION 0.67 • n=206 Participants
|
2.08 unit on a scale
STANDARD_DEVIATION 0.68 • n=7 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
AM and PM runny nose
|
2.41 unit on a scale
STANDARD_DEVIATION 0.54 • n=99 Participants
|
2.38 unit on a scale
STANDARD_DEVIATION 0.57 • n=107 Participants
|
2.39 unit on a scale
STANDARD_DEVIATION 0.55 • n=206 Participants
|
2.39 unit on a scale
STANDARD_DEVIATION 0.55 • n=7 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
AM and PM nasal itching
|
2.28 unit on a scale
STANDARD_DEVIATION 0.59 • n=99 Participants
|
2.34 unit on a scale
STANDARD_DEVIATION 0.55 • n=107 Participants
|
2.29 unit on a scale
STANDARD_DEVIATION 0.57 • n=206 Participants
|
2.30 unit on a scale
STANDARD_DEVIATION 0.57 • n=7 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
AM and PM nasal congestion
|
2.52 unit on a scale
STANDARD_DEVIATION 0.43 • n=99 Participants
|
2.52 unit on a scale
STANDARD_DEVIATION 0.47 • n=107 Participants
|
2.52 unit on a scale
STANDARD_DEVIATION 0.45 • n=206 Participants
|
2.52 unit on a scale
STANDARD_DEVIATION 0.45 • n=7 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
AM sneezing
|
1.73 unit on a scale
STANDARD_DEVIATION 0.84 • n=99 Participants
|
1.75 unit on a scale
STANDARD_DEVIATION 0.91 • n=107 Participants
|
1.73 unit on a scale
STANDARD_DEVIATION 0.88 • n=206 Participants
|
1.74 unit on a scale
STANDARD_DEVIATION 0.88 • n=7 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
AM runny nose
|
2.32 unit on a scale
STANDARD_DEVIATION 0.58 • n=99 Participants
|
2.26 unit on a scale
STANDARD_DEVIATION 0.64 • n=107 Participants
|
2.29 unit on a scale
STANDARD_DEVIATION 0.64 • n=206 Participants
|
2.29 unit on a scale
STANDARD_DEVIATION 0.62 • n=7 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
AM nasal itching
|
2.22 unit on a scale
STANDARD_DEVIATION 0.66 • n=99 Participants
|
2.23 unit on a scale
STANDARD_DEVIATION 0.64 • n=107 Participants
|
2.20 unit on a scale
STANDARD_DEVIATION 0.68 • n=206 Participants
|
2.22 unit on a scale
STANDARD_DEVIATION 0.66 • n=7 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
AM nasal congestion
|
2.50 unit on a scale
STANDARD_DEVIATION 0.47 • n=99 Participants
|
2.48 unit on a scale
STANDARD_DEVIATION 0.51 • n=107 Participants
|
2.47 unit on a scale
STANDARD_DEVIATION 0.53 • n=206 Participants
|
2.48 unit on a scale
STANDARD_DEVIATION 0.50 • n=7 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
PM sneezing
|
1.79 unit on a scale
STANDARD_DEVIATION 0.82 • n=99 Participants
|
1.79 unit on a scale
STANDARD_DEVIATION 0.89 • n=107 Participants
|
1.77 unit on a scale
STANDARD_DEVIATION 0.88 • n=206 Participants
|
1.78 unit on a scale
STANDARD_DEVIATION 0.86 • n=7 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
PM runny nose
|
2.22 unit on a scale
STANDARD_DEVIATION 0.65 • n=99 Participants
|
2.18 unit on a scale
STANDARD_DEVIATION 0.69 • n=107 Participants
|
2.16 unit on a scale
STANDARD_DEVIATION 0.70 • n=206 Participants
|
2.19 unit on a scale
STANDARD_DEVIATION 0.68 • n=7 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
PM nasal itching
|
2.13 unit on a scale
STANDARD_DEVIATION 0.68 • n=99 Participants
|
2.17 unit on a scale
STANDARD_DEVIATION 0.66 • n=107 Participants
|
2.10 unit on a scale
STANDARD_DEVIATION 0.69 • n=206 Participants
|
2.13 unit on a scale
STANDARD_DEVIATION 0.67 • n=7 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
PM nasal congestion
|
2.36 unit on a scale
STANDARD_DEVIATION 0.54 • n=99 Participants
|
2.36 unit on a scale
STANDARD_DEVIATION 0.57 • n=107 Participants
|
2.34 unit on a scale
STANDARD_DEVIATION 0.55 • n=206 Participants
|
2.35 unit on a scale
STANDARD_DEVIATION 0.55 • n=7 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
AM and PM sneezing
|
1.76 unit on a scale
STANDARD_DEVIATION 0.81 • n=99 Participants
|
1.77 unit on a scale
STANDARD_DEVIATION 0.86 • n=107 Participants
|
1.75 unit on a scale
STANDARD_DEVIATION 0.86 • n=206 Participants
|
1.76 unit on a scale
STANDARD_DEVIATION 0.84 • n=7 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
AM and PM runny nose
|
2.27 unit on a scale
STANDARD_DEVIATION 0.60 • n=99 Participants
|
2.22 unit on a scale
STANDARD_DEVIATION 0.62 • n=107 Participants
|
2.23 unit on a scale
STANDARD_DEVIATION 0.64 • n=206 Participants
|
2.24 unit on a scale
STANDARD_DEVIATION 0.62 • n=7 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
AM and PM nasal itching
|
2.18 unit on a scale
STANDARD_DEVIATION 0.65 • n=99 Participants
|
2.20 unit on a scale
STANDARD_DEVIATION 0.61 • n=107 Participants
|
2.15 unit on a scale
STANDARD_DEVIATION 0.66 • n=206 Participants
|
2.17 unit on a scale
STANDARD_DEVIATION 0.64 • n=7 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
AM and PM nasal congestion
|
2.43 unit on a scale
STANDARD_DEVIATION 0.48 • n=99 Participants
|
2.42 unit on a scale
STANDARD_DEVIATION 0.51 • n=107 Participants
|
2.41 unit on a scale
STANDARD_DEVIATION 0.51 • n=206 Participants
|
2.42 unit on a scale
STANDARD_DEVIATION 0.50 • n=7 Participants
|
|
Baseline Individual Reflective Ocular Symptom Score (rOSS) in Subjects with (rTOSS) ≥5.0
AM itching eyes
|
2.49 unit on a scale
STANDARD_DEVIATION 0.44 • n=99 Participants
|
2.52 unit on a scale
STANDARD_DEVIATION 0.43 • n=107 Participants
|
2.48 unit on a scale
STANDARD_DEVIATION 0.44 • n=206 Participants
|
2.49 unit on a scale
STANDARD_DEVIATION 0.43 • n=7 Participants
|
|
Baseline Individual Reflective Ocular Symptom Score (rOSS) in Subjects with (rTOSS) ≥5.0
AM redness of eyes
|
2.31 unit on a scale
STANDARD_DEVIATION 0.57 • n=99 Participants
|
2.28 unit on a scale
STANDARD_DEVIATION 0.62 • n=107 Participants
|
2.24 unit on a scale
STANDARD_DEVIATION 0.60 • n=206 Participants
|
2.28 unit on a scale
STANDARD_DEVIATION 0.60 • n=7 Participants
|
|
Baseline Individual Reflective Ocular Symptom Score (rOSS) in Subjects with (rTOSS) ≥5.0
AM tearing eyes
|
2.30 unit on a scale
STANDARD_DEVIATION 0.48 • n=99 Participants
|
2.37 unit on a scale
STANDARD_DEVIATION 0.51 • n=107 Participants
|
2.28 unit on a scale
STANDARD_DEVIATION 0.50 • n=206 Participants
|
2.31 unit on a scale
STANDARD_DEVIATION 0.50 • n=7 Participants
|
|
Baseline Individual Reflective Ocular Symptom Score (rOSS) in Subjects with (rTOSS) ≥5.0
PM itching eyes
|
2.47 unit on a scale
STANDARD_DEVIATION 0.45 • n=99 Participants
|
2.50 unit on a scale
STANDARD_DEVIATION 0.47 • n=107 Participants
|
2.45 unit on a scale
STANDARD_DEVIATION 0.48 • n=206 Participants
|
2.47 unit on a scale
STANDARD_DEVIATION 0.47 • n=7 Participants
|
|
Baseline Individual Reflective Ocular Symptom Score (rOSS) in Subjects with (rTOSS) ≥5.0
PM redness of eyes
|
2.28 unit on a scale
STANDARD_DEVIATION 0.58 • n=99 Participants
|
2.26 unit on a scale
STANDARD_DEVIATION 0.65 • n=107 Participants
|
2.24 unit on a scale
STANDARD_DEVIATION 0.62 • n=206 Participants
|
2.26 unit on a scale
STANDARD_DEVIATION 0.62 • n=7 Participants
|
|
Baseline Individual Reflective Ocular Symptom Score (rOSS) in Subjects with (rTOSS) ≥5.0
PM tearing eyes
|
2.25 unit on a scale
STANDARD_DEVIATION 0.56 • n=99 Participants
|
2.34 unit on a scale
STANDARD_DEVIATION 0.52 • n=107 Participants
|
2.25 unit on a scale
STANDARD_DEVIATION 0.51 • n=206 Participants
|
2.28 unit on a scale
STANDARD_DEVIATION 0.53 • n=7 Participants
|
|
Baseline Individual Reflective Ocular Symptom Score (rOSS) in Subjects with (rTOSS) ≥5.0
AM and PM itching eyes
|
2.48 unit on a scale
STANDARD_DEVIATION 0.43 • n=99 Participants
|
2.51 unit on a scale
STANDARD_DEVIATION 0.43 • n=107 Participants
|
2.46 unit on a scale
STANDARD_DEVIATION 0.44 • n=206 Participants
|
2.48 unit on a scale
STANDARD_DEVIATION 0.43 • n=7 Participants
|
|
Baseline Individual Reflective Ocular Symptom Score (rOSS) in Subjects with (rTOSS) ≥5.0
AM and PM redness of eyes
|
2.29 unit on a scale
STANDARD_DEVIATION 0.55 • n=99 Participants
|
2.27 unit on a scale
STANDARD_DEVIATION 0.62 • n=107 Participants
|
2.24 unit on a scale
STANDARD_DEVIATION 0.59 • n=206 Participants
|
2.27 unit on a scale
STANDARD_DEVIATION 0.59 • n=7 Participants
|
|
Baseline Individual Reflective Ocular Symptom Score (rOSS) in Subjects with (rTOSS) ≥5.0
AM and PM tearing eyes
|
2.27 unit on a scale
STANDARD_DEVIATION 0.49 • n=99 Participants
|
2.35 unit on a scale
STANDARD_DEVIATION 0.49 • n=107 Participants
|
2.27 unit on a scale
STANDARD_DEVIATION 0.48 • n=206 Participants
|
2.30 unit on a scale
STANDARD_DEVIATION 0.49 • n=7 Participants
|
|
Baseline Individual Instantaneous Ocular Symptom Score (iOSS) in subjects with (iTOSS) ≥5.0
AM itching eyes
|
2.47 unit on a scale
STANDARD_DEVIATION 0.43 • n=99 Participants
|
2.47 unit on a scale
STANDARD_DEVIATION 0.44 • n=107 Participants
|
2.45 unit on a scale
STANDARD_DEVIATION 0.47 • n=206 Participants
|
2.46 unit on a scale
STANDARD_DEVIATION 0.44 • n=7 Participants
|
|
Baseline Individual Instantaneous Ocular Symptom Score (iOSS) in subjects with (iTOSS) ≥5.0
AM redness of eyes
|
2.34 unit on a scale
STANDARD_DEVIATION 0.56 • n=99 Participants
|
2.29 unit on a scale
STANDARD_DEVIATION 0.60 • n=107 Participants
|
2.31 unit on a scale
STANDARD_DEVIATION 0.52 • n=206 Participants
|
2.31 unit on a scale
STANDARD_DEVIATION 0.56 • n=7 Participants
|
|
Baseline Individual Instantaneous Ocular Symptom Score (iOSS) in subjects with (iTOSS) ≥5.0
AM tearing eyes
|
2.26 unit on a scale
STANDARD_DEVIATION 0.50 • n=99 Participants
|
2.32 unit on a scale
STANDARD_DEVIATION 0.52 • n=107 Participants
|
2.29 unit on a scale
STANDARD_DEVIATION 0.45 • n=206 Participants
|
2.29 unit on a scale
STANDARD_DEVIATION 0.49 • n=7 Participants
|
|
Baseline Individual Instantaneous Ocular Symptom Score (iOSS) in subjects with (iTOSS) ≥5.0
PM itching eyes
|
2.41 unit on a scale
STANDARD_DEVIATION 0.46 • n=99 Participants
|
2.40 unit on a scale
STANDARD_DEVIATION 0.50 • n=107 Participants
|
2.41 unit on a scale
STANDARD_DEVIATION 0.47 • n=206 Participants
|
2.41 unit on a scale
STANDARD_DEVIATION 0.47 • n=7 Participants
|
|
Baseline Individual Instantaneous Ocular Symptom Score (iOSS) in subjects with (iTOSS) ≥5.0
PM redness of eyes
|
2.30 unit on a scale
STANDARD_DEVIATION 0.58 • n=99 Participants
|
2.24 unit on a scale
STANDARD_DEVIATION 0.62 • n=107 Participants
|
2.28 unit on a scale
STANDARD_DEVIATION 0.54 • n=206 Participants
|
2.27 unit on a scale
STANDARD_DEVIATION 0.58 • n=7 Participants
|
|
Baseline Individual Instantaneous Ocular Symptom Score (iOSS) in subjects with (iTOSS) ≥5.0
PM tearing eyes
|
2.19 unit on a scale
STANDARD_DEVIATION 0.57 • n=99 Participants
|
2.25 unit on a scale
STANDARD_DEVIATION 0.56 • n=107 Participants
|
2.22 unit on a scale
STANDARD_DEVIATION 0.48 • n=206 Participants
|
2.22 unit on a scale
STANDARD_DEVIATION 0.54 • n=7 Participants
|
|
Baseline Individual Instantaneous Ocular Symptom Score (iOSS) in subjects with (iTOSS) ≥5.0
AM and PM itching eyes
|
2.44 unit on a scale
STANDARD_DEVIATION 0.42 • n=99 Participants
|
2.43 unit on a scale
STANDARD_DEVIATION 0.44 • n=107 Participants
|
2.43 unit on a scale
STANDARD_DEVIATION 0.44 • n=206 Participants
|
2.43 unit on a scale
STANDARD_DEVIATION 0.43 • n=7 Participants
|
|
Baseline Individual Instantaneous Ocular Symptom Score (iOSS) in subjects with (iTOSS) ≥5.0
AM and PM redness of eyes
|
2.32 unit on a scale
STANDARD_DEVIATION 0.54 • n=99 Participants
|
2.26 unit on a scale
STANDARD_DEVIATION 0.58 • n=107 Participants
|
2.29 unit on a scale
STANDARD_DEVIATION 0.50 • n=206 Participants
|
2.29 unit on a scale
STANDARD_DEVIATION 0.54 • n=7 Participants
|
|
Baseline Individual Instantaneous Ocular Symptom Score (iOSS) in subjects with (iTOSS) ≥5.0
AM and PM tearing eyes
|
2.23 unit on a scale
STANDARD_DEVIATION 0.50 • n=99 Participants
|
2.28 unit on a scale
STANDARD_DEVIATION 0.50 • n=107 Participants
|
2.26 unit on a scale
STANDARD_DEVIATION 0.42 • n=206 Participants
|
2.26 unit on a scale
STANDARD_DEVIATION 0.48 • n=7 Participants
|
|
Baseline Rhinoconjunctivitis Quality of Life Questionnaire [RQLQ(S)] ≥3.0
|
4.30 units on a scale
STANDARD_DEVIATION 0.80 • n=99 Participants
|
4.42 units on a scale
STANDARD_DEVIATION 0.87 • n=107 Participants
|
4.36 units on a scale
STANDARD_DEVIATION 0.78 • n=206 Participants
|
4.36 units on a scale
STANDARD_DEVIATION 0.82 • n=7 Participants
|
PRIMARY outcome
Timeframe: Week 0-2Population: Intent to Treat Population. Not all subjects analyzed due to missing data.
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.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=225 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=226 Participants
80 μg once daily
|
Placebo
n=218 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over the Two-week Treatment Period.
|
-1.74 Units on a scale
Standard Error 0.15
|
-1.75 Units on a scale
Standard Error 0.15
|
-0.72 Units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Week 0-2Population: Intent to Treat Population. Not all subjects analyzed due to missing data.
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.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=225 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=226 Participants
80 μg once daily
|
Placebo
n=218 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.
|
-0.36 units on a scale
Standard Error 0.04
|
-0.36 units on a scale
Standard Error 0.04
|
-0.18 units on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Week 0-2Population: Intent to Treat Population. Not all subjects analyzed due to missing data.
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 1. = mild 2. = moderate 3. = 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.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=161 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=159 Participants
80 μg once daily
|
Placebo
n=164 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported AM and PM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0
|
-1.21 units on a scale
Standard Error 0.13
|
-1.40 units on a scale
Standard Error 0.13
|
-0.88 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Week 0-2Population: Intent to Treat Population. Not all subjects analyzed due to missing data.
RQLQ(S) in impaired subjects with baseline RQLQ\[S\] score ≥3.0. RQLQ(S) 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.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=148 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=162 Participants
80 μg once daily
|
Placebo
n=145 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in the RQLQ(S) Overall Score at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0
|
-1.41 units on a scale
Standard Error 0.12
|
-1.44 units on a scale
Standard Error 0.11
|
-0.79 units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Week 0-2Population: Intent to Treat Population. Not all subjects analyzed due to missing data.
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.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=225 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=226 Participants
80 μg once daily
|
Placebo
n=218 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 2-week Treatment Period.
|
-1.77 units on a scale
Standard Error 0.15
|
-1.84 units on a scale
Standard Error 0.15
|
-0.77 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Week 0-2Population: Intent to Treat Population. Not all subjects analyzed due to missing data.
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.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=225 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=226 Participants
80 μg once daily
|
Placebo
n=218 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 2 Week Treatment Period.
|
-1.70 units on a scale
Standard Error 0.16
|
-1.67 units on a scale
Standard Error 0.16
|
-0.66 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Week0-2Population: Intent to Treat Population. Not all subjects analyzed due to missing data.
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.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=225 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=226 Participants
80 μg once daily
|
Placebo
n=218 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 2-week Treatment Period.
|
-1.56 units on a scale
Standard Error 0.15
|
-1.60 units on a scale
Standard Error 0.15
|
-0.71 units on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Week 0-2Population: Intent to Treat Population. Not all subjects analyzed due to missing data.
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.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=225 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=226 Participants
80 μg once daily
|
Placebo
n=218 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.
|
-1.46 units on a scale
Standard Error 0.16
|
-1.56 units on a scale
Standard Error 0.15
|
-0.64 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Week 0-2Population: In subjects with baseline TOSS ≥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 1. = mild 2. = moderate 3. = 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.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=161 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=159 Participants
80 μg once daily
|
Placebo
n=164 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported AM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0
|
-1.24 units on a scale
Standard Error 0.14
|
-1.41 units on a scale
Standard Error 0.14
|
-0.88 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Week 0-2Population: In subjects with baseline TOSS ≥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 1. = mild 2. = moderate 3. = 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.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=161 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=159 Participants
80 μg once daily
|
Placebo
n=164 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported PM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0
|
-1.21 units on a scale
Standard Error 0.14
|
-1.39 units on a scale
Standard Error 0.14
|
-0.88 units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Week 0-2Population: In subjects with baseline TOSS ≥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 1. = mild 2. = moderate 3. = 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.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=146 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=141 Participants
80 μg once daily
|
Placebo
n=137 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported AM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.
|
-1.12 units on a scale
Standard Error 0.14
|
-1.24 units on a scale
Standard Error 0.14
|
-0.72 units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Week 0-2Population: In subjects with baseline TOSS ≥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 1. = mild 2. = moderate 3. = 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.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=146 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=141 Participants
80 μg once daily
|
Placebo
n=137 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported PM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.
|
-1.14 units on a scale
Standard Error 0.15
|
-1.20 units on a scale
Standard Error 0.15
|
-0.74 units on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Week 0-2Population: In subjects with baseline TOSS ≥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 1. = mild 2. = moderate 3. = 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.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=146 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=141 Participants
80 μg once daily
|
Placebo
n=137 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported AM and PM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.
|
-1.13 units on a scale
Standard Error 0.14
|
-1.21 units on a scale
Standard Error 0.14
|
-0.72 units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Week 0-2Population: Intent to Treat Population. Not all subjects analyzed due to missing data.
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); 1. = mild 2. = moderate 3. = severe Instantaneous NSS 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.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=225 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=226 Participants
80 μg once daily
|
Placebo
n=218 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 2-week Treatment Period
Nasal Itching
|
-0.45 units on a scale
Standard Error 0.04
|
-0.39 units on a scale
Standard Error 0.04
|
-0.21 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 2-week Treatment Period
Sneezing
|
-0.36 units on a scale
Standard Error 0.04
|
-0.40 units on a scale
Standard Error 0.04
|
-0.14 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 2-week Treatment Period
Runny Nose
|
-0.40 units on a scale
Standard Error 0.04
|
-0.45 units on a scale
Standard Error 0.04
|
-0.18 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 2-week Treatment Period
Nasal Congestion
|
-0.35 units on a scale
Standard Error 0.04
|
-0.37 units on a scale
Standard Error 0.04
|
-0.18 units on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Week 0-2Population: Intent to Treat Population. Not all subjects analyzed due to missing data.
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); 1. = mild 2. = moderate 3. = severe Instantaneous NSS 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.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=225 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=226 Participants
80 μg once daily
|
Placebo
n=218 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 2-week Treatment Period
Runny Nose
|
-0.36 units on a scale
Standard Error 0.04
|
-0.42 units on a scale
Standard Error 0.04
|
-0.16 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 2-week Treatment Period
Nasal Congestion
|
-0.36 units on a scale
Standard Error 0.04
|
-0.36 units on a scale
Standard Error 0.04
|
-0.18 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 2-week Treatment Period
Sneezing
|
-0.35 units on a scale
Standard Error 0.04
|
-0.40 units on a scale
Standard Error 0.04
|
-0.14 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 2-week Treatment Period
Nasal Itching
|
-0.39 units on a scale
Standard Error 0.04
|
-0.37 units on a scale
Standard Error 0.04
|
-0.16 units on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Week 0-2Population: Intent to Treat Population. Not all subjects analyzed due to missing data.
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); 1. = mild 2. = moderate 3. = severe Instantaneous NSS 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.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=225 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=226 Participants
80 μg once daily
|
Placebo
n=218 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 2-week Treatment Period
Sneezing
|
-0.35 units on a scale
Standard Error 0.04
|
-0.40 units on a scale
Standard Error 0.04
|
-0.14 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 2-week Treatment Period
Runny Nose
|
-0.38 units on a scale
Standard Error 0.04
|
-0.43 units on a scale
Standard Error 0.04
|
-0.17 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 2-week Treatment Period
Nasal Itching
|
-0.42 units on a scale
Standard Error 0.04
|
-0.38 units on a scale
Standard Error 0.04
|
-0.19 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 2-week Treatment Period
Nasal Congestion
|
-0.36 units on a scale
Standard Error 0.04
|
-0.36 units on a scale
Standard Error 0.04
|
-0.18 units on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Week 0-2Population: Intent to Treat Population. Not all subjects analyzed due to missing data.
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); 1. = mild 2. = moderate 3. = severe Reflective NSS 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.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=225 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=226 Participants
80 μg once daily
|
Placebo
n=218 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported Individual AM Reflective Nasal Symptom Scores (NSS) Averaged Over the 2-week Treatment Period.
runny nose
|
-0.44 units on a scale
Standard Error 0.04
|
-0.51 units on a scale
Standard Error 0.04
|
-0.21 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported Individual AM Reflective Nasal Symptom Scores (NSS) Averaged Over the 2-week Treatment Period.
nasal itching
|
-0.47 units on a scale
Standard Error 0.04
|
-0.43 units on a scale
Standard Error 0.04
|
-0.20 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported Individual AM Reflective Nasal Symptom Scores (NSS) Averaged Over the 2-week Treatment Period.
nasal congestion
|
-0.40 units on a scale
Standard Error 0.04
|
-0.38 units on a scale
Standard Error 0.04
|
-0.18 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported Individual AM Reflective Nasal Symptom Scores (NSS) Averaged Over the 2-week Treatment Period.
sneezing
|
-0.47 units on a scale
Standard Error 0.04
|
-0.51 units on a scale
Standard Error 0.04
|
-0.18 units on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Week 0-2Population: Intent to Treat Population. Not all subjects analyzed due to missing data.
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 1. = mild 2. = moderate 3. = severe Reflective NSS 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.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=225 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=226 Participants
80 μg once daily
|
Placebo
n=218 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 2-week Treatment Period.
Nasal Congestion
|
-0.39 units on a scale
Standard Error 0.04
|
-0.40 units on a scale
Standard Error 0.04
|
-0.20 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 2-week Treatment Period.
Sneezing
|
-0.43 units on a scale
Standard Error 0.04
|
-0.43 units on a scale
Standard Error 0.04
|
-0.14 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 2-week Treatment Period.
Runny Nose
|
-0.43 units on a scale
Standard Error 0.04
|
-0.45 units on a scale
Standard Error 0.04
|
-0.16 units on a scale
Standard Error 0.05
|
|
Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 2-week Treatment Period.
Nasal Itching
|
-0.45 units on a scale
Standard Error 0.04
|
-0.39 units on a scale
Standard Error 0.04
|
-0.16 units on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Week 0-2Population: Intent to Treat Population. Not all subjects analyzed due to missing data.
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 1. = mild 2. = moderate 3. = severe Reflective NSS 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.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=225 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=226 Participants
80 μg once daily
|
Placebo
n=218 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 2-week Treatment Period.
Runny Nose
|
-0.44 units on a scale
Standard Error 0.04
|
-0.41 units on a scale
Standard Error 0.04
|
-0.18 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 2-week Treatment Period.
Sneezing
|
-0.45 units on a scale
Standard Error 0.04
|
-0.47 units on a scale
Standard Error 0.04
|
-0.16 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 2-week Treatment Period.
Nasal Itching
|
-0.44 units on a scale
Standard Error 0.04
|
-0.41 units on a scale
Standard Error 0.04
|
-0.18 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 2-week Treatment Period.
Nasal Congestion
|
-0.39 units on a scale
Standard Error 0.04
|
-0.39 units on a scale
Standard Error 0.04
|
-0.19 units on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Week 0-2Population: In Subjects With Baseline TOSS≥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 1. = mild 2. = moderate 3. = severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=146 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=141 Participants
80 μg once daily
|
Placebo
n=137 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported Individual AM Instantaneous OSS in Subjects With Baseline TOSS≥5.0
itching eyes
|
-0.37 units on a scale
Standard Error 0.05
|
-0.39 units on a scale
Standard Error 0.05
|
-0.24 units on a scale
Standard Error 0.05
|
|
Change From Baseline in Daily Subject-reported Individual AM Instantaneous OSS in Subjects With Baseline TOSS≥5.0
redness of eyes
|
-0.38 units on a scale
Standard Error 0.05
|
-0.38 units on a scale
Standard Error 0.05
|
-0.21 units on a scale
Standard Error 0.05
|
|
Change From Baseline in Daily Subject-reported Individual AM Instantaneous OSS in Subjects With Baseline TOSS≥5.0
tearing eyes
|
-0.37 units on a scale
Standard Error 0.05
|
-0.47 units on a scale
Standard Error 0.05
|
-0.27 units on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Week 0-2Population: In Subjects With Baseline TOSS≥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 1. = mild 2. = moderate 3. = severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=146 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=141 Participants
80 μg once daily
|
Placebo
n=137 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported Individual PM Instantaneous OSS in Subjects With Baseline TOSS≥5.0
itching eyes
|
-0.38 units on a scale
Standard Error 0.05
|
-0.37 units on a scale
Standard Error 0.05
|
-0.25 units on a scale
Standard Error 0.05
|
|
Change From Baseline in Daily Subject-reported Individual PM Instantaneous OSS in Subjects With Baseline TOSS≥5.0
redness of eyes
|
-0.39 units on a scale
Standard Error 0.05
|
-0.37 units on a scale
Standard Error 0.05
|
-0.27 units on a scale
Standard Error 0.05
|
|
Change From Baseline in Daily Subject-reported Individual PM Instantaneous OSS in Subjects With Baseline TOSS≥5.0
tearing eyes
|
-0.38 units on a scale
Standard Error 0.05
|
-0.45 units on a scale
Standard Error 0.05
|
-0.22 units on a scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Week 0-2Population: In Subjects With Baseline TOSS≥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 1. = mild 2. = moderate 3. = severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=146 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=141 Participants
80 μg once daily
|
Placebo
n=137 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous OSS in Subjects With Baseline TOSS≥5.0
redness of eyes
|
-0.39 units on a scale
Standard Error 0.05
|
-0.38 units on a scale
Standard Error 0.05
|
-0.24 units on a scale
Standard Error 0.05
|
|
Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous OSS in Subjects With Baseline TOSS≥5.0
itching eyes
|
-0.37 units on a scale
Standard Error 0.05
|
-0.38 units on a scale
Standard Error 0.05
|
-0.24 units on a scale
Standard Error 0.05
|
|
Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous OSS in Subjects With Baseline TOSS≥5.0
tearing eyes
|
-0.37 units on a scale
Standard Error 0.05
|
-0.46 units on a scale
Standard Error 0.05
|
-0.24 units on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Week 0-2Population: In Subjects With Baseline TOSS ≥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 1. = mild 2. = moderate 3. = severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=161 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=159 Participants
80 μg once daily
|
Placebo
n=164 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported Individual AM Reflective OSS in Subjects With Baseline TOSS ≥5.0
itching eyes
|
-0.41 participants
Standard Error 0.05
|
-0.45 participants
Standard Error 0.05
|
-0.31 participants
Standard Error 0.05
|
|
Change From Baseline in Daily Subject-reported Individual AM Reflective OSS in Subjects With Baseline TOSS ≥5.0
redness of eyes
|
-0.41 participants
Standard Error 0.05
|
-0.42 participants
Standard Error 0.05
|
-0.25 participants
Standard Error 0.05
|
|
Change From Baseline in Daily Subject-reported Individual AM Reflective OSS in Subjects With Baseline TOSS ≥5.0
tearing eyes
|
-0.42 participants
Standard Error 0.05
|
-0.53 participants
Standard Error 0.05
|
-0.33 participants
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Week 0-2Population: In Subjects With Baseline TOSS ≥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 1. = mild 2. = moderate 3. = severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=161 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=159 Participants
80 μg once daily
|
Placebo
n=164 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported Individual PM Reflective OSS in Subjects With Baseline TOSS ≥5.0
itching eyes
|
-0.42 participants
Standard Error 0.05
|
-0.43 participants
Standard Error 0.05
|
-0.28 participants
Standard Error 0.05
|
|
Change From Baseline in Daily Subject-reported Individual PM Reflective OSS in Subjects With Baseline TOSS ≥5.0
redness of eyes
|
-0.39 participants
Standard Error 0.05
|
-0.42 participants
Standard Error 0.05
|
-0.28 participants
Standard Error 0.05
|
|
Change From Baseline in Daily Subject-reported Individual PM Reflective OSS in Subjects With Baseline TOSS ≥5.0
tearing eyes
|
-0.40 participants
Standard Error 0.05
|
-0.54 participants
Standard Error 0.05
|
-0.32 participants
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Week 0-2Population: In Subjects With Baseline TOSS ≥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 1. = mild 2. = moderate 3. = severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=161 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=159 Participants
80 μg once daily
|
Placebo
n=164 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported Individual AM and PM Reflective OSS in Subjects With Baseline TOSS ≥5.0
itching eyes
|
-0.42 units on a scale
Standard Error 0.05
|
-0.44 units on a scale
Standard Error 0.05
|
-0.29 units on a scale
Standard Error 0.05
|
|
Change From Baseline in Daily Subject-reported Individual AM and PM Reflective OSS in Subjects With Baseline TOSS ≥5.0
redness of eyes
|
-0.39 units on a scale
Standard Error 0.05
|
-0.42 units on a scale
Standard Error 0.05
|
-0.27 units on a scale
Standard Error 0.05
|
|
Change From Baseline in Daily Subject-reported Individual AM and PM Reflective OSS in Subjects With Baseline TOSS ≥5.0
tearing eyes
|
-0.41 units on a scale
Standard Error 0.05
|
-0.53 units on a scale
Standard Error 0.05
|
-0.32 units on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Week 0-2Population: In Impaired Subjects with Baseline RQLQ(S) Score of ≥3.0
RQLQ(S) in subjects with baseline RQLQ\[S\] score ≥3.0. RQLQ(S) 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.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=148 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=162 Participants
80 μg once daily
|
Placebo
n=145 Participants
Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in the RQLQ(S) Domains at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0
Domain 1: Activities
|
-1.39 units on a scale
Standard Error 0.13
|
-1.34 units on a scale
Standard Error 0.12
|
-0.70 units on a scale
Standard Error 0.13
|
|
Change From Baseline in the RQLQ(S) Domains at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0
Domain 6: Eye Symptoms
|
-1.25 units on a scale
Standard Error 0.13
|
-1.25 units on a scale
Standard Error 0.12
|
-0.81 units on a scale
Standard Error 0.13
|
|
Change From Baseline in the RQLQ(S) Domains at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0
Domain 7: Emotional
|
-1.36 units on a scale
Standard Error 0.13
|
-1.36 units on a scale
Standard Error 0.12
|
-0.82 units on a scale
Standard Error 0.13
|
|
Change From Baseline in the RQLQ(S) Domains at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0
Overall Score
|
-1.41 units on a scale
Standard Error 0.12
|
-1.44 units on a scale
Standard Error 0.11
|
-0.79 units on a scale
Standard Error 0.12
|
|
Change From Baseline in the RQLQ(S) Domains at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0
Domain 2: Sleep
|
-1.49 units on a scale
Standard Error 0.14
|
-1.60 units on a scale
Standard Error 0.13
|
-0.83 units on a scale
Standard Error 0.14
|
|
Change From Baseline in the RQLQ(S) Domains at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0
Domain 3: Non-Nose/Eye Symptoms
|
-1.33 units on a scale
Standard Error 0.12
|
-1.21 units on a scale
Standard Error 0.11
|
-0.67 units on a scale
Standard Error 0.12
|
|
Change From Baseline in the RQLQ(S) Domains at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0
Domain 4: Practical Problems
|
-1.62 units on a scale
Standard Error 0.13
|
-1.64 units on a scale
Standard Error 0.12
|
-0.91 units on a scale
Standard Error 0.13
|
|
Change From Baseline in the RQLQ(S) Domains at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0
Domain 5: Nasal Symptoms
|
-1.52 units on a scale
Standard Error 0.13
|
-1.61 units on a scale
Standard Error 0.12
|
-0.83 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Week 0-2The 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. The evaluation is made separately for each dose level of Ciclesonide HFA compared to placebo.
Outcome measures
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=225 Participants
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=226 Participants
80 μg once daily
|
Placebo
Placebo once daily
|
|---|---|---|---|
|
Time to Maximal Effect Over the 2-week of Double-blind Treatment Period.
|
7 Days
Standard Error 0.18
|
8 Days
Standard Error 0.19
|
—
|
Adverse Events
Ciclesonide HFA Nasal Aerosol 160 μg
Ciclesonide HFA Nasal Aerosol 80 μg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ciclesonide HFA Nasal Aerosol 160 μg
n=225 participants at risk
160 μg once daily
|
Ciclesonide HFA Nasal Aerosol 80 μg
n=226 participants at risk
80 μg once daily
|
Placebo
n=220 participants at risk
Placebo once daily
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.7%
6/225 • Number of events 6
|
1.3%
3/226 • Number of events 3
|
1.8%
4/220 • Number of events 4
|
Additional Information
Respiratory Medical Director
Sunovion
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER