Trial Outcomes & Findings for A 6 Month Safety and Efficacy Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) in the Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older (NCT NCT00953147)
NCT ID: NCT00953147
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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1110 participants
Primary outcome timeframe
Weeks 0-6
Results posted on
2012-06-13
Participant Flow
Participant milestones
| Measure |
Ciclesonide HFA 80 Mcg Once Daily
Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
|
Ciclesonide HFA 160 Mcg Once Daily
Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
|
Placebo Once Daily
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
|
|---|---|---|---|
|
Overall Study
STARTED
|
298
|
505
|
307
|
|
Overall Study
COMPLETED
|
261
|
439
|
265
|
|
Overall Study
NOT COMPLETED
|
37
|
66
|
42
|
Reasons for withdrawal
| Measure |
Ciclesonide HFA 80 Mcg Once Daily
Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
|
Ciclesonide HFA 160 Mcg Once Daily
Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
|
Placebo Once Daily
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
16
|
6
|
|
Overall Study
Protocol Violation
|
2
|
8
|
4
|
|
Overall Study
Withdrawal by Subject
|
13
|
15
|
12
|
|
Overall Study
Lost to Follow-up
|
8
|
9
|
4
|
|
Overall Study
Physician Decision
|
2
|
7
|
3
|
|
Overall Study
Other
|
4
|
11
|
13
|
Baseline Characteristics
A 6 Month Safety and Efficacy Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) in the Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
Baseline characteristics by cohort
| Measure |
Ciclesonide HFA 80 Mcg Once Daily
n=298 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
|
Ciclesonide HFA 160 Mcg Once Daily
n=505 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
|
Placebo Once Daily
n=307 Participants
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
|
Total
n=1110 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
27 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
264 Participants
n=5 Participants
|
455 Participants
n=7 Participants
|
282 Participants
n=5 Participants
|
1001 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Age Continuous
|
37.5 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
36.5 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
38.0 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
37.2 years
STANDARD_DEVIATION 13.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
196 Participants
n=5 Participants
|
310 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
716 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=5 Participants
|
195 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
394 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
62 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
216 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
236 Participants
n=5 Participants
|
411 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
894 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity
White/Caucasian
|
249 participants
n=5 Participants
|
420 participants
n=7 Participants
|
253 participants
n=5 Participants
|
922 participants
n=4 Participants
|
|
Race/Ethnicity
Black or African American
|
40 participants
n=5 Participants
|
65 participants
n=7 Participants
|
41 participants
n=5 Participants
|
146 participants
n=4 Participants
|
|
Race/Ethnicity
Asian
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Race/Ethnicity
American Indian or Alaska Native
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity
Other
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
3 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Race/Ethnicity
Multiple
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
0 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Baseline Reflective Total Nasal Symptom Score (rTNSS)
AM
|
8.51 units on a scale
STANDARD_DEVIATION 1.89 • n=5 Participants
|
8.48 units on a scale
STANDARD_DEVIATION 1.88 • n=7 Participants
|
8.60 units on a scale
STANDARD_DEVIATION 1.96 • n=5 Participants
|
8.52 units on a scale
STANDARD_DEVIATION 1.90 • n=4 Participants
|
|
Baseline Reflective Total Nasal Symptom Score (rTNSS)
PM
|
8.53 units on a scale
STANDARD_DEVIATION 1.91 • n=5 Participants
|
8.54 units on a scale
STANDARD_DEVIATION 1.84 • n=7 Participants
|
8.64 units on a scale
STANDARD_DEVIATION 1.92 • n=5 Participants
|
8.57 units on a scale
STANDARD_DEVIATION 1.88 • n=4 Participants
|
|
Baseline Reflective Total Nasal Symptom Score (rTNSS)
AM and PM
|
8.53 units on a scale
STANDARD_DEVIATION 1.82 • n=5 Participants
|
8.50 units on a scale
STANDARD_DEVIATION 1.81 • n=7 Participants
|
8.62 units on a scale
STANDARD_DEVIATION 1.88 • n=5 Participants
|
8.54 units on a scale
STANDARD_DEVIATION 1.83 • n=4 Participants
|
|
Baseline Instanteous Total Nasal Symptom Score (iTNSS)
AM
|
7.93 units on a scale
STANDARD_DEVIATION 2.27 • n=5 Participants
|
7.89 units on a scale
STANDARD_DEVIATION 2.24 • n=7 Participants
|
8.01 units on a scale
STANDARD_DEVIATION 2.37 • n=5 Participants
|
7.93 units on a scale
STANDARD_DEVIATION 2.29 • n=4 Participants
|
|
Baseline Instanteous Total Nasal Symptom Score (iTNSS)
PM
|
7.38 units on a scale
STANDARD_DEVIATION 2.43 • n=5 Participants
|
7.38 units on a scale
STANDARD_DEVIATION 2.41 • n=7 Participants
|
7.39 units on a scale
STANDARD_DEVIATION 2.55 • n=5 Participants
|
7.38 units on a scale
STANDARD_DEVIATION 2.46 • n=4 Participants
|
|
Baseline Instanteous Total Nasal Symptom Score (iTNSS)
AM and PM
|
7.66 units on a scale
STANDARD_DEVIATION 2.28 • n=5 Participants
|
7.64 units on a scale
STANDARD_DEVIATION 2.27 • n=7 Participants
|
7.70 units on a scale
STANDARD_DEVIATION 2.38 • n=5 Participants
|
7.66 units on a scale
STANDARD_DEVIATION 2.30 • n=4 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
AM Sneezing
|
1.73 units on a scale
STANDARD_DEVIATION 0.73 • n=5 Participants
|
1.71 units on a scale
STANDARD_DEVIATION 0.72 • n=7 Participants
|
1.75 units on a scale
STANDARD_DEVIATION 0.74 • n=5 Participants
|
1.73 units on a scale
STANDARD_DEVIATION 0.73 • n=4 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
AM Runny Nose
|
2.24 units on a scale
STANDARD_DEVIATION 0.59 • n=5 Participants
|
2.22 units on a scale
STANDARD_DEVIATION 0.59 • n=7 Participants
|
2.28 units on a scale
STANDARD_DEVIATION 0.60 • n=5 Participants
|
2.24 units on a scale
STANDARD_DEVIATION 0.59 • n=4 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
AM Nasal Itching
|
2.06 units on a scale
STANDARD_DEVIATION 0.64 • n=5 Participants
|
2.08 units on a scale
STANDARD_DEVIATION 0.62 • n=7 Participants
|
2.09 units on a scale
STANDARD_DEVIATION 0.69 • n=5 Participants
|
2.08 units on a scale
STANDARD_DEVIATION 0.64 • n=4 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
AM Nasal Congestion
|
2.48 units on a scale
STANDARD_DEVIATION 0.49 • n=5 Participants
|
2.46 units on a scale
STANDARD_DEVIATION 0.49 • n=7 Participants
|
2.47 units on a scale
STANDARD_DEVIATION 0.53 • n=5 Participants
|
2.47 units on a scale
STANDARD_DEVIATION 0.50 • n=4 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
PM Sneezing
|
1.81 units on a scale
STANDARD_DEVIATION 0.68 • n=5 Participants
|
1.81 units on a scale
STANDARD_DEVIATION 0.70 • n=7 Participants
|
1.88 units on a scale
STANDARD_DEVIATION 0.69 • n=5 Participants
|
1.83 units on a scale
STANDARD_DEVIATION 0.69 • n=4 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
PM Runny Nose
|
2.23 units on a scale
STANDARD_DEVIATION 0.59 • n=5 Participants
|
2.23 units on a scale
STANDARD_DEVIATION 0.60 • n=7 Participants
|
2.27 units on a scale
STANDARD_DEVIATION 0.60 • n=5 Participants
|
2.24 units on a scale
STANDARD_DEVIATION 0.60 • n=4 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
PM Nasal Itching
|
2.08 units on a scale
STANDARD_DEVIATION 0.64 • n=5 Participants
|
2.12 units on a scale
STANDARD_DEVIATION 0.60 • n=7 Participants
|
2.12 units on a scale
STANDARD_DEVIATION 0.69 • n=5 Participants
|
2.11 units on a scale
STANDARD_DEVIATION 0.64 • n=4 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
PM Nasal Congestion
|
2.42 units on a scale
STANDARD_DEVIATION 0.53 • n=5 Participants
|
2.38 units on a scale
STANDARD_DEVIATION 0.52 • n=7 Participants
|
2.38 units on a scale
STANDARD_DEVIATION 0.54 • n=5 Participants
|
2.39 units on a scale
STANDARD_DEVIATION 0.53 • n=4 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
AM and PM Sneezing
|
1.77 units on a scale
STANDARD_DEVIATION 0.68 • n=5 Participants
|
1.76 units on a scale
STANDARD_DEVIATION 0.69 • n=7 Participants
|
1.81 units on a scale
STANDARD_DEVIATION 0.69 • n=5 Participants
|
1.78 units on a scale
STANDARD_DEVIATION 0.69 • n=4 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
AM and PM Runny Nose
|
2.24 units on a scale
STANDARD_DEVIATION 0.56 • n=5 Participants
|
2.22 units on a scale
STANDARD_DEVIATION 0.58 • n=7 Participants
|
2.27 units on a scale
STANDARD_DEVIATION 0.58 • n=5 Participants
|
2.24 units on a scale
STANDARD_DEVIATION 0.57 • n=4 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
AM and PM Nasal Itching
|
2.07 units on a scale
STANDARD_DEVIATION 0.62 • n=5 Participants
|
2.10 units on a scale
STANDARD_DEVIATION 0.60 • n=7 Participants
|
2.11 units on a scale
STANDARD_DEVIATION 0.67 • n=5 Participants
|
2.09 units on a scale
STANDARD_DEVIATION 0.62 • n=4 Participants
|
|
Baseline Reflective Nasal Symptom Score (rNSS)
AM and PM Nasal Congestion
|
2.45 units on a scale
STANDARD_DEVIATION 0.48 • n=5 Participants
|
2.42 units on a scale
STANDARD_DEVIATION 0.48 • n=7 Participants
|
2.42 units on a scale
STANDARD_DEVIATION 0.51 • n=5 Participants
|
2.43 units on a scale
STANDARD_DEVIATION 0.49 • n=4 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
AM Sneezing
|
1.38 units on a scale
STANDARD_DEVIATION 0.91 • n=5 Participants
|
1.40 units on a scale
STANDARD_DEVIATION 0.88 • n=7 Participants
|
1.43 units on a scale
STANDARD_DEVIATION 0.93 • n=5 Participants
|
1.40 units on a scale
STANDARD_DEVIATION 0.91 • n=4 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
AM Runny Nose
|
2.14 units on a scale
STANDARD_DEVIATION 0.68 • n=5 Participants
|
2.13 units on a scale
STANDARD_DEVIATION 0.68 • n=7 Participants
|
2.20 units on a scale
STANDARD_DEVIATION 0.67 • n=5 Participants
|
2.15 units on a scale
STANDARD_DEVIATION 0.68 • n=4 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
AM Nasal Itching
|
2.00 units on a scale
STANDARD_DEVIATION 0.72 • n=5 Participants
|
1.99 units on a scale
STANDARD_DEVIATION 0.69 • n=7 Participants
|
2.00 units on a scale
STANDARD_DEVIATION 0.76 • n=5 Participants
|
2.00 units on a scale
STANDARD_DEVIATION 0.72 • n=4 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
AM Nasal Congestion
|
2.41 units on a scale
STANDARD_DEVIATION 0.53 • n=5 Participants
|
2.38 units on a scale
STANDARD_DEVIATION 0.56 • n=7 Participants
|
2.38 units on a scale
STANDARD_DEVIATION 0.60 • n=5 Participants
|
2.39 units on a scale
STANDARD_DEVIATION 0.57 • n=4 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
PM Sneezing
|
1.30 units on a scale
STANDARD_DEVIATION 0.90 • n=5 Participants
|
1.32 units on a scale
STANDARD_DEVIATION 0.89 • n=7 Participants
|
1.36 units on a scale
STANDARD_DEVIATION 0.90 • n=5 Participants
|
1.32 units on a scale
STANDARD_DEVIATION 0.90 • n=4 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
PM Runny Nose
|
1.98 units on a scale
STANDARD_DEVIATION 0.73 • n=5 Participants
|
1.98 units on a scale
STANDARD_DEVIATION 0.74 • n=7 Participants
|
2.02 units on a scale
STANDARD_DEVIATION 0.72 • n=5 Participants
|
1.99 units on a scale
STANDARD_DEVIATION 0.73 • n=4 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
PM Nasal Itching
|
1.87 units on a scale
STANDARD_DEVIATION 0.73 • n=5 Participants
|
1.90 units on a scale
STANDARD_DEVIATION 0.71 • n=7 Participants
|
1.83 units on a scale
STANDARD_DEVIATION 0.80 • n=5 Participants
|
1.87 units on a scale
STANDARD_DEVIATION 0.74 • n=4 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
PM Nasal Congestion
|
2.22 units on a scale
STANDARD_DEVIATION 0.61 • n=5 Participants
|
2.19 units on a scale
STANDARD_DEVIATION 0.63 • n=7 Participants
|
2.17 units on a scale
STANDARD_DEVIATION 0.66 • n=5 Participants
|
2.19 units on a scale
STANDARD_DEVIATION 0.63 • n=4 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
AM and PM Sneezing
|
1.35 units on a scale
STANDARD_DEVIATION 0.89 • n=5 Participants
|
1.36 units on a scale
STANDARD_DEVIATION 0.86 • n=7 Participants
|
1.39 units on a scale
STANDARD_DEVIATION 0.89 • n=5 Participants
|
1.36 units on a scale
STANDARD_DEVIATION 0.88 • n=4 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
AM and PM Runny Nose
|
2.06 units on a scale
STANDARD_DEVIATION 0.67 • n=5 Participants
|
2.05 units on a scale
STANDARD_DEVIATION 0.68 • n=7 Participants
|
2.11 units on a scale
STANDARD_DEVIATION 0.65 • n=5 Participants
|
2.07 units on a scale
STANDARD_DEVIATION 0.67 • n=4 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
AM and PM Nasal Itching
|
1.94 units on a scale
STANDARD_DEVIATION 0.70 • n=5 Participants
|
1.95 units on a scale
STANDARD_DEVIATION 0.68 • n=7 Participants
|
1.91 units on a scale
STANDARD_DEVIATION 0.75 • n=5 Participants
|
1.93 units on a scale
STANDARD_DEVIATION 0.70 • n=4 Participants
|
|
Baseline Instantaneous Nasal Symptom Score (iNSS)
AM and PM Nasal Congestion
|
2.32 units on a scale
STANDARD_DEVIATION 0.54 • n=5 Participants
|
2.28 units on a scale
STANDARD_DEVIATION 0.57 • n=7 Participants
|
2.28 units on a scale
STANDARD_DEVIATION 0.60 • n=5 Participants
|
2.29 units on a scale
STANDARD_DEVIATION 0.57 • n=4 Participants
|
|
Baseline Rhinoconjunctivitis Quality of Life Questionnaire score [RQLQ (S)] )≥3.0
|
4.16 units on a scale
STANDARD_DEVIATION 0.77 • n=5 Participants
|
4.05 units on a scale
STANDARD_DEVIATION 0.76 • n=7 Participants
|
4.12 units on a scale
STANDARD_DEVIATION 0.78 • n=5 Participants
|
4.10 units on a scale
STANDARD_DEVIATION 0.77 • n=4 Participants
|
PRIMARY outcome
Timeframe: Weeks 0-6Population: 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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Outcome measures
| Measure |
Ciclesonide HFA 80 Mcg Once Daily
n=298 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
|
Ciclesonide HFA 160 Mcg Once Daily
n=504 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
|
Placebo Once Daily
n=305 Participants
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS (rTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment
|
-1.97 units on a scale
Standard Error 0.13
|
-1.82 units on a scale
Standard Error 0.10
|
-1.28 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Weeks 0-6Population: 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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Outcome measures
| Measure |
Ciclesonide HFA 80 Mcg Once Daily
n=298 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
|
Ciclesonide HFA 160 Mcg Once Daily
n=504 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
|
Placebo Once Daily
n=305 Participants
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS (iTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment
|
-1.77 units on a scale
Standard Error 0.12
|
-1.60 units on a scale
Standard Error 0.10
|
-1.18 units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Weeks 0-6Population: 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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Outcome measures
| Measure |
Ciclesonide HFA 80 Mcg Once Daily
n=297 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
|
Ciclesonide HFA 160 Mcg Once Daily
n=503 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
|
Placebo Once Daily
n=304 Participants
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
|
-1.94 units on a scale
Standard Error 0.13
|
-1.78 units on a scale
Standard Error 0.10
|
-1.25 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Weeks 0-6Population: 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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Outcome measures
| Measure |
Ciclesonide HFA 80 Mcg Once Daily
n=298 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
|
Ciclesonide HFA 160 Mcg Once Daily
n=504 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
|
Placebo Once Daily
n=305 Participants
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
|
-2.01 units on a scale
Standard Error 0.13
|
-1.88 units on a scale
Standard Error 0.10
|
-1.32 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Weeks 0-6Population: Intent to Treat Population. Not all participants 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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Outcome measures
| Measure |
Ciclesonide HFA 80 Mcg Once Daily
n=297 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
|
Ciclesonide HFA 160 Mcg Once Daily
n=503 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
|
Placebo Once Daily
n=304 Participants
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
|
-1.78 units on a scale
Standard Error 0.12
|
-1.67 units on a scale
Standard Error 0.10
|
-1.23 units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Weeks 0-6Population: 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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Outcome measures
| Measure |
Ciclesonide HFA 80 Mcg Once Daily
n=298 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
|
Ciclesonide HFA 160 Mcg Once Daily
n=504 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
|
Placebo Once Daily
n=305 Participants
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
|
-1.76 units on a scale
Standard Error 0.13
|
-1.55 units on a scale
Standard Error 0.10
|
-1.15 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Weeks 0 - 6Population: 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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Outcome measures
| Measure |
Ciclesonide HFA 80 Mcg Once Daily
n=297 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
|
Ciclesonide HFA 160 Mcg Once Daily
n=503 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
|
Placebo Once Daily
n=304 Participants
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment
Sneezing
|
-0.51 units on a scale
Standard Error 0.04
|
-0.47 units on a scale
Standard Error 0.03
|
-0.31 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment
Runny Nose
|
-0.49 units on a scale
Standard Error 0.04
|
-0.44 units on a scale
Standard Error 0.03
|
-0.31 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment
Nasal Itching
|
-0.52 units on a scale
Standard Error 0.04
|
-0.48 units on a scale
Standard Error 0.03
|
-0.38 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment
Nasal Congestion
|
-0.42 units on a scale
Standard Error 0.03
|
-0.38 units on a scale
Standard Error 0.03
|
-0.25 units on a scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Weeks 0-6Population: 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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Outcome measures
| Measure |
Ciclesonide HFA 80 Mcg Once Daily
n=298 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
|
Ciclesonide HFA 160 Mcg Once Daily
n=504 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
|
Placebo Once Daily
n=305 Participants
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment
Sneezing
|
-0.53 units on a scale
Standard Error 0.04
|
-0.52 units on a scale
Standard Error 0.03
|
-0.35 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment
Runny Nose
|
-0.51 units on a scale
Standard Error 0.04
|
-0.47 units on a scale
Standard Error 0.03
|
-0.31 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment
Nasal Itching
|
-0.54 units on a scale
Standard Error 0.04
|
-0.51 units on a scale
Standard Error 0.03
|
-0.39 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment
Nasal Congestion
|
-0.43 units on a scale
Standard Error 0.03
|
-0.39 units on a scale
Standard Error 0.03
|
-0.26 units on a scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Weeks 0-6Population: 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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Outcome measures
| Measure |
Ciclesonide HFA 80 Mcg Once Daily
n=298 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
|
Ciclesonide HFA 160 Mcg Once Daily
n=504 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
|
Placebo Once Daily
n=305 Participants
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported AM & PM rNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period.
Sneezing
|
-0.52 units on a scale
Standard Error 0.04
|
-0.49 units on a scale
Standard Error 0.03
|
-0.33 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported AM & PM rNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period.
Runny Nose
|
-0.50 units on a scale
Standard Error 0.04
|
-0.45 units on a scale
Standard Error 0.03
|
-0.31 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported AM & PM rNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period.
Nasal Itching
|
-0.53 units on a scale
Standard Error 0.04
|
-0.49 units on a scale
Standard Error 0.03
|
-0.39 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported AM & PM rNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period.
Nasal Congestion
|
-0.42 units on a scale
Standard Error 0.03
|
-0.39 units on a scale
Standard Error 0.03
|
-0.26 units on a scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Weeks 0-6Population: 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 Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Outcome measures
| Measure |
Ciclesonide HFA 80 Mcg Once Daily
n=297 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
|
Ciclesonide HFA 160 Mcg Once Daily
n=503 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
|
Placebo Once Daily
n=304 Participants
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported AM iNSS Averaged the First 6 Weeks of the Double-blind Treatment
Sneezing
|
-0.45 units on a scale
Standard Error 0.04
|
-0.44 units on a scale
Standard Error 0.03
|
-0.34 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported AM iNSS Averaged the First 6 Weeks of the Double-blind Treatment
Runny Nose
|
-0.47 units on a scale
Standard Error 0.04
|
-0.43 units on a scale
Standard Error 0.03
|
-0.30 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported AM iNSS Averaged the First 6 Weeks of the Double-blind Treatment
Nasal Itching
|
-0.51 units on a scale
Standard Error 0.04
|
-0.47 units on a scale
Standard Error 0.03
|
-0.37 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported AM iNSS Averaged the First 6 Weeks of the Double-blind Treatment
Nasal Congestion
|
-0.36 units on a scale
Standard Error 0.03
|
-0.33 units on a scale
Standard Error 0.02
|
-0.22 units on a scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Weeks 0-6Population: Intent to Treat Population.
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 Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Outcome measures
| Measure |
Ciclesonide HFA 80 Mcg Once Daily
n=298 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
|
Ciclesonide HFA 160 Mcg Once Daily
n=505 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
|
Placebo Once Daily
n=307 Participants
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported PM iNSS Averaged the First 6 Weeks of the Double-blind Treatment
Sneezing
|
-0.44 units on a scale
Standard Error 0.04
|
-0.39 units on a scale
Standard Error 0.03
|
-0.31 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported PM iNSS Averaged the First 6 Weeks of the Double-blind Treatment
Runny Nose
|
-0.47 units on a scale
Standard Error 0.04
|
-0.40 units on a scale
Standard Error 0.03
|
-0.29 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported PM iNSS Averaged the First 6 Weeks of the Double-blind Treatment
Nasal Itching
|
-0.49 units on a scale
Standard Error 0.04
|
-0.45 units on a scale
Standard Error 0.03
|
-0.33 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported PM iNSS Averaged the First 6 Weeks of the Double-blind Treatment
Nasal Congestion
|
-0.37 units on a scale
Standard Error 0.03
|
-0.31 units on a scale
Standard Error 0.03
|
-0.22 units on a scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Weeks 0-6Population: 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 Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Outcome measures
| Measure |
Ciclesonide HFA 80 Mcg Once Daily
n=298 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
|
Ciclesonide HFA 160 Mcg Once Daily
n=504 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
|
Placebo Once Daily
n=305 Participants
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
|
|---|---|---|---|
|
Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period
Sneezing
|
-0.44 units on a scale
Standard Error 0.04
|
-0.41 units on a scale
Standard Error 0.03
|
-0.32 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period
Runny Nose
|
-0.47 units on a scale
Standard Error 0.04
|
-0.41 units on a scale
Standard Error 0.03
|
-0.30 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period
Nasal Itching
|
-0.50 units on a scale
Standard Error 0.04
|
-0.46 units on a scale
Standard Error 0.03
|
-0.35 units on a scale
Standard Error 0.04
|
|
Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period
Nasal Congestion
|
-0.36 units on a scale
Standard Error 0.03
|
-0.32 units on a scale
Standard Error 0.02
|
-0.22 units on a scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: Intent to Treat Population. Not all subjects analyzed due to missing data.
RQLQ(S) scores 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 80 Mcg Once Daily
n=109 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
|
Ciclesonide HFA 160 Mcg Once Daily
n=191 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
|
Placebo Once Daily
n=101 Participants
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
|
|---|---|---|---|
|
Change From Baseline to Week 6 in Rhinoconjunctivitis Quality of Life Questionnaire With Standardized [RQLQ(S)] Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0
|
-1.55 units on a scale
Standard Error 0.13
|
-1.27 units on a scale
Standard Error 0.11
|
-0.96 units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Intent to Treat Population. Not all subjects analyzed due to missing data.
RQLQ(S) scores 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 80 Mcg Once Daily
n=100 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
|
Ciclesonide HFA 160 Mcg Once Daily
n=160 Participants
Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
|
Placebo Once Daily
n=86 Participants
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
|
|---|---|---|---|
|
Change From Baseline to Month 6 (Week 26) in RQLQ(S) Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0.
|
-1.67 units on a scale
Standard Error 0.14
|
-1.62 units on a scale
Standard Error 0.11
|
-1.40 units on a scale
Standard Error 0.15
|
Adverse Events
Ciclesonide HFA 80 Mcg Once Daily
Serious events: 6 serious events
Other events: 148 other events
Deaths: 0 deaths
Ciclesonide HFA 160 Mcg Once Daily
Serious events: 8 serious events
Other events: 234 other events
Deaths: 0 deaths
Placebo Once Daily
Serious events: 6 serious events
Other events: 131 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ciclesonide HFA 80 Mcg Once Daily
n=334 participants at risk；n=298 participants at risk
|
Ciclesonide HFA 160 Mcg Once Daily
n=475 participants at risk；n=505 participants at risk
|
Placebo Once Daily
n=243 participants at risk；n=307 participants at risk
|
|---|---|---|---|
|
Cardiac disorders
Artrioventricular block second degree
|
0.00%
0/298 • 6 Months
|
0.00%
0/505 • 6 Months
|
0.33%
1/307 • Number of events 1 • 6 Months
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/298 • 6 Months
|
0.20%
1/505 • Number of events 1 • 6 Months
|
0.00%
0/307 • 6 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/298 • 6 Months
|
0.20%
1/505 • Number of events 1 • 6 Months
|
0.00%
0/307 • 6 Months
|
|
Psychiatric disorders
Suicidal ideation
|
0.34%
1/298 • Number of events 1 • 6 Months
|
0.00%
0/505 • 6 Months
|
0.00%
0/307 • 6 Months
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.34%
1/298 • Number of events 1 • 6 Months
|
0.00%
0/505 • 6 Months
|
0.00%
0/307 • 6 Months
|
|
Reproductive system and breast disorders
Pelvic adhesions
|
0.34%
1/298 • Number of events 1 • 6 Months
|
0.00%
0/505 • 6 Months
|
0.00%
0/307 • 6 Months
|
|
Vascular disorders
Hypertension
|
0.00%
0/298 • 6 Months
|
0.00%
0/505 • 6 Months
|
0.33%
1/307 • Number of events 1 • 6 Months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/298 • 6 Months
|
0.20%
1/505 • Number of events 1 • 6 Months
|
0.00%
0/307 • 6 Months
|
|
Gastrointestinal disorders
Colonic atony
|
0.00%
0/298 • 6 Months
|
0.20%
1/505 • Number of events 1 • 6 Months
|
0.00%
0/307 • 6 Months
|
|
Gastrointestinal disorders
Megacolon
|
0.00%
0/298 • 6 Months
|
0.20%
1/505 • Number of events 1 • 6 Months
|
0.00%
0/307 • 6 Months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/298 • 6 Months
|
0.00%
0/505 • 6 Months
|
0.65%
2/307 • Number of events 2 • 6 Months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/298 • 6 Months
|
0.20%
1/505 • Number of events 1 • 6 Months
|
0.00%
0/307 • 6 Months
|
|
General disorders
Hernia obstructive
|
0.00%
0/298 • 6 Months
|
0.00%
0/505 • 6 Months
|
0.33%
1/307 • Number of events 1 • 6 Months
|
|
Infections and infestations
Appendicitis
|
0.34%
1/298 • Number of events 1 • 6 Months
|
0.00%
0/505 • 6 Months
|
0.00%
0/307 • 6 Months
|
|
Infections and infestations
Pneumonia
|
0.34%
1/298 • Number of events 1 • 6 Months
|
0.00%
0/505 • 6 Months
|
0.00%
0/307 • 6 Months
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.00%
0/298 • 6 Months
|
0.20%
1/505 • Number of events 1 • 6 Months
|
0.00%
0/307 • 6 Months
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.00%
0/298 • 6 Months
|
0.20%
1/505 • Number of events 1 • 6 Months
|
0.00%
0/307 • 6 Months
|
|
Nervous system disorders
Mononeuropathy mulitplex
|
0.00%
0/298 • 6 Months
|
0.20%
1/505 • Number of events 1 • 6 Months
|
0.00%
0/307 • 6 Months
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.00%
0/298 • 6 Months
|
0.20%
1/505 • Number of events 1 • 6 Months
|
0.00%
0/307 • 6 Months
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.34%
1/298 • Number of events 1 • 6 Months
|
0.00%
0/505 • 6 Months
|
0.33%
1/307 • Number of events 1 • 6 Months
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/298 • 6 Months
|
0.20%
1/505 • Number of events 1 • 6 Months
|
0.00%
0/307 • 6 Months
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/298 • 6 Months
|
0.20%
1/505 • Number of events 1 • 6 Months
|
0.00%
0/307 • 6 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/298 • 6 Months
|
0.00%
0/505 • 6 Months
|
0.33%
1/307 • Number of events 1 • 6 Months
|
|
Social circumstances
Imprisonment
|
0.00%
0/298 • 6 Months
|
0.20%
1/505 • Number of events 1 • 6 Months
|
0.00%
0/307 • 6 Months
|
Other adverse events
| Measure |
Ciclesonide HFA 80 Mcg Once Daily
n=334 participants at risk；n=298 participants at risk
|
Ciclesonide HFA 160 Mcg Once Daily
n=475 participants at risk；n=505 participants at risk
|
Placebo Once Daily
n=243 participants at risk；n=307 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
4/334 • Number of events 4 • 6 Months
|
1.5%
7/475 • Number of events 8 • 6 Months
|
2.9%
7/243 • Number of events 7 • 6 Months
|
|
Gastrointestinal disorders
Nausea
|
2.7%
9/334 • Number of events 10 • 6 Months
|
1.7%
8/475 • Number of events 8 • 6 Months
|
0.82%
2/243 • Number of events 2 • 6 Months
|
|
General disorders
Instillation site discomfort
|
3.0%
10/334 • Number of events 11 • 6 Months
|
1.9%
9/475 • Number of events 11 • 6 Months
|
0.00%
0/243 • 6 Months
|
|
Infections and infestations
Bronchitis
|
2.1%
7/334 • Number of events 7 • 6 Months
|
2.3%
11/475 • Number of events 11 • 6 Months
|
2.5%
6/243 • Number of events 6 • 6 Months
|
|
Infections and infestations
Influenza
|
1.8%
6/334 • Number of events 6 • 6 Months
|
1.9%
9/475 • Number of events 11 • 6 Months
|
1.2%
3/243 • Number of events 4 • 6 Months
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
14/334 • Number of events 17 • 6 Months
|
6.3%
30/475 • Number of events 35 • 6 Months
|
7.8%
19/243 • Number of events 26 • 6 Months
|
|
Infections and infestations
Pharyngitis streptococcal
|
2.1%
7/334 • Number of events 8 • 6 Months
|
1.1%
5/475 • Number of events 5 • 6 Months
|
2.1%
5/243 • Number of events 6 • 6 Months
|
|
Infections and infestations
Sinusitis
|
4.2%
14/334 • Number of events 16 • 6 Months
|
5.7%
27/475 • Number of events 30 • 6 Months
|
7.0%
17/243 • Number of events 18 • 6 Months
|
|
Infections and infestations
Upper respiratory tract infection
|
12.9%
43/334 • Number of events 54 • 6 Months
|
13.9%
66/475 • Number of events 74 • 6 Months
|
11.9%
29/243 • Number of events 37 • 6 Months
|
|
Infections and infestations
Urinary tract infection
|
3.9%
13/334 • Number of events 13 • 6 Months
|
2.9%
14/475 • Number of events 16 • 6 Months
|
3.7%
9/243 • Number of events 10 • 6 Months
|
|
Infections and infestations
Viral upper respiratory tract infection
|
4.5%
15/334 • Number of events 16 • 6 Months
|
2.7%
13/475 • Number of events 14 • 6 Months
|
2.9%
7/243 • Number of events 9 • 6 Months
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.8%
6/334 • Number of events 7 • 6 Months
|
1.5%
7/475 • Number of events 9 • 6 Months
|
0.82%
2/243 • Number of events 2 • 6 Months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
5/334 • Number of events 12 • 6 Months
|
2.3%
11/475 • Number of events 11 • 6 Months
|
4.1%
10/243 • Number of events 12 • 6 Months
|
|
Nervous system disorders
Headache
|
6.3%
21/334 • Number of events 36 • 6 Months
|
3.6%
17/475 • Number of events 27 • 6 Months
|
5.8%
14/243 • Number of events 18 • 6 Months
|
|
Nervous system disorders
Sinus headache
|
1.8%
6/334 • Number of events 10 • 6 Months
|
0.84%
4/475 • Number of events 7 • 6 Months
|
2.9%
7/243 • Number of events 8 • 6 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.7%
9/334 • Number of events 9 • 6 Months
|
4.0%
19/475 • Number of events 19 • 6 Months
|
3.3%
8/243 • Number of events 9 • 6 Months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.2%
34/334 • Number of events 57 • 6 Months
|
12.0%
57/475 • Number of events 98 • 6 Months
|
9.9%
24/243 • Number of events 42 • 6 Months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
2.4%
8/334 • Number of events 9 • 6 Months
|
3.4%
16/475 • Number of events 16 • 6 Months
|
0.82%
2/243 • Number of events 2 • 6 Months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
2.1%
7/334 • Number of events 7 • 6 Months
|
2.5%
12/475 • Number of events 14 • 6 Months
|
0.82%
2/243 • Number of events 2 • 6 Months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum disorder
|
1.5%
5/334 • Number of events 6 • 6 Months
|
3.4%
16/475 • Number of events 21 • 6 Months
|
1.2%
3/243 • Number of events 4 • 6 Months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.6%
12/334 • Number of events 15 • 6 Months
|
4.2%
20/475 • Number of events 22 • 6 Months
|
4.1%
10/243 • Number of events 11 • 6 Months
|
|
Vascular disorders
Hypertension
|
1.2%
4/334 • Number of events 4 • 6 Months
|
1.5%
7/475 • Number of events 8 • 6 Months
|
3.3%
8/243 • Number of events 8 • 6 Months
|
Additional Information
Respiratory Medical Director
Sunovion
Phone: 1-866-503-6351
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER