Trial Outcomes & Findings for A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR). (NCT NCT01451541)
NCT ID: NCT01451541
Last Updated: 2014-05-06
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
848 participants
Primary outcome timeframe
Weeks 0-6
Results posted on
2014-05-06
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: placebo - one dose per nostril
|
Ciclesonide Nasal Aerosol 37mcg
ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
|
Ciclesonide Nasal Aerosol 74 mcg
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
283
|
282
|
281
|
|
Overall Study
COMPLETED
|
247
|
257
|
254
|
|
Overall Study
NOT COMPLETED
|
36
|
25
|
27
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: placebo - one dose per nostril
|
Ciclesonide Nasal Aerosol 37mcg
ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
|
Ciclesonide Nasal Aerosol 74 mcg
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
3
|
6
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
7
|
|
Overall Study
Withdrawal by Subject
|
15
|
8
|
6
|
|
Overall Study
randomization error, noncompliance
|
11
|
10
|
8
|
Baseline Characteristics
A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR).
Baseline characteristics by cohort
| Measure |
Placebo
n=283 Participants
Placebo: placebo - one dose per nostril
|
Ciclesonide Nasal Aerosol 37mcg
n=282 Participants
ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
|
Ciclesonide Nasal Aerosol 74 mcg
n=281 Participants
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
|
Total
n=846 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
283 Participants
n=5 Participants
|
282 Participants
n=7 Participants
|
281 Participants
n=5 Participants
|
846 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
363 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
163 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
483 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
224 Participants
n=5 Participants
|
216 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
656 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
89 participants
n=5 Participants
|
101 participants
n=7 Participants
|
91 participants
n=5 Participants
|
281 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
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, Customized
Not Hispanic or Latino
|
194 participants
n=5 Participants
|
181 participants
n=7 Participants
|
190 participants
n=5 Participants
|
565 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
283 participants
n=5 Participants
|
282 participants
n=7 Participants
|
281 participants
n=5 Participants
|
846 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Weeks 0-6Population: The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.
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 |
Placebo
n=278 Participants
Placebo: placebo - one dose per nostril
|
Ciclesonide Nasal Aerosol 37mcg
n=280 Participants
ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
|
Ciclesonide Nasal Aerosol 74 mcg
n=275 Participants
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
|
|---|---|---|---|
|
The Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Averaged Weekly Over the First 6 Weeks of the Double-blind Treatment.
|
-1.51 units on a scale
Standard Error 0.130
|
-2.10 units on a scale
Standard Error 0.130
|
-1.98 units on a scale
Standard Error 0.131
|
SECONDARY outcome
Timeframe: Weeks 0 -6Population: The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.
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 |
Placebo
n=278 Participants
Placebo: placebo - one dose per nostril
|
Ciclesonide Nasal Aerosol 37mcg
n=280 Participants
ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
|
Ciclesonide Nasal Aerosol 74 mcg
n=276 Participants
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
|
|---|---|---|---|
|
Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Averaged Weekly Over the First 6 Weeks of Double-blind Treatment
|
-1.29 units on a scale
Standard Error 0.122
|
-1.77 units on a scale
Standard Error 0.122
|
-1.72 units on a scale
Standard Error 0.123
|
SECONDARY outcome
Timeframe: Weeks 0 -6Population: The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.
PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses.
Outcome measures
| Measure |
Placebo
n=269 Participants
Placebo: placebo - one dose per nostril
|
Ciclesonide Nasal Aerosol 37mcg
n=268 Participants
ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
|
Ciclesonide Nasal Aerosol 74 mcg
n=270 Participants
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
|
|---|---|---|---|
|
Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the First 6 Weeks of Double-blind Treatment
|
-0.39 units on a scale
Standard Error 0.05
|
-0.51 units on a scale
Standard Error 0.05
|
-0.30 units on a scale
Standard Error 0.054
|
SECONDARY outcome
Timeframe: Weeks 0 -12Population: The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.
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 twelve week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement
Outcome measures
| Measure |
Placebo
n=278 Participants
Placebo: placebo - one dose per nostril
|
Ciclesonide Nasal Aerosol 37mcg
n=280 Participants
ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
|
Ciclesonide Nasal Aerosol 74 mcg
n=275 Participants
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Average Subject-reported AM and PM rTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period
|
-1.92 units on a scale
Standard Error 0.13
|
-2.60 units on a scale
Standard Error 0.14
|
-2.47 units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Weeks 0 -12Population: The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.
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 twelve week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Outcome measures
| Measure |
Placebo
n=278 Participants
Placebo: placebo - one dose per nostril
|
Ciclesonide Nasal Aerosol 37mcg
n=280 Participants
ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
|
Ciclesonide Nasal Aerosol 74 mcg
n=276 Participants
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Average Subject-reported AM and PM iTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period
|
-1.69 units on a scale
Standard Error 0.13
|
-2.22 units on a scale
Standard Error 0.13
|
-2.15 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Weeks 0 -6Population: The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.
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 |
Placebo
n=278 Participants
Placebo: placebo - one dose per nostril
|
Ciclesonide Nasal Aerosol 37mcg
n=280 Participants
ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
|
Ciclesonide Nasal Aerosol 74 mcg
n=276 Participants
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
|
|---|---|---|---|
|
Change From Baseline in Daily Average Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment
|
-1.26 units on a scale
Standard Error 0.12
|
-1.75 units on a scale
Standard Error 0.12
|
-1.74 units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Weeks 0 -12Population: The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.
PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses.
Outcome measures
| Measure |
Placebo
n=271 Participants
Placebo: placebo - one dose per nostril
|
Ciclesonide Nasal Aerosol 37mcg
n=269 Participants
ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
|
Ciclesonide Nasal Aerosol 74 mcg
n=272 Participants
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
|
|---|---|---|---|
|
Change From Baseline in Daily PRQLQ Overall Score at the End of the 12-week Double-blind Treatment Period
|
-0.54 units on a scale
Standard Error 0.059
|
-0.68 units on a scale
Standard Error 0.059
|
-0.47 units on a scale
Standard Error 0.059
|
SECONDARY outcome
Timeframe: Weeks 0 -6Population: The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.
The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between active ciclesonide nasal aerosol 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 time to achieve at least 90% of these estimated differences was calculated.
Outcome measures
| Measure |
Placebo
n=282 Participants
Placebo: placebo - one dose per nostril
|
Ciclesonide Nasal Aerosol 37mcg
n=281 Participants
ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
|
Ciclesonide Nasal Aerosol 74 mcg
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
|
|---|---|---|---|
|
Time to Maximal Effect [Time to >= 90% Maximum Difference From Placebo in LS Means (Days)]
|
39 Number of Days
|
10 Number of Days
|
—
|
SECONDARY outcome
Timeframe: Weeks 0 -12Outcome measures
| Measure |
Placebo
n=283 Participants
Placebo: placebo - one dose per nostril
|
Ciclesonide Nasal Aerosol 37mcg
n=282 Participants
ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
|
Ciclesonide Nasal Aerosol 74 mcg
n=281 Participants
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
|
|---|---|---|---|
|
Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs
Any TEAE
|
154 participants
|
142 participants
|
143 participants
|
|
Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs
Any TEAE during first 6 weeks of double-blind
|
114 participants
|
99 participants
|
102 participants
|
|
Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs
Potentially related AE
|
46 participants
|
39 participants
|
46 participants
|
|
Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs
Local AE
|
49 participants
|
45 participants
|
46 participants
|
|
Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs
Discontinued study drug due to an AE
|
4 participants
|
3 participants
|
6 participants
|
|
Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs
Severe AE
|
12 participants
|
14 participants
|
17 participants
|
|
Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs
Serious AE
|
1 participants
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Weeks 0 -12Outcome measures
| Measure |
Placebo
n=283 Participants
Placebo: placebo - one dose per nostril
|
Ciclesonide Nasal Aerosol 37mcg
n=282 Participants
ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
|
Ciclesonide Nasal Aerosol 74 mcg
n=281 Participants
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
|
|---|---|---|---|
|
Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs
Any TEAE
|
54.4 percentage of subjects
|
50.4 percentage of subjects
|
50.9 percentage of subjects
|
|
Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs
Any TEAE during first 6 weeks of double-blind
|
40.3 percentage of subjects
|
35.1 percentage of subjects
|
36.3 percentage of subjects
|
|
Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs
Potentially related AE
|
16.3 percentage of subjects
|
13.8 percentage of subjects
|
16.4 percentage of subjects
|
|
Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs
Local AE
|
17.3 percentage of subjects
|
16.0 percentage of subjects
|
16.4 percentage of subjects
|
|
Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs
Discontinued study drug due to an AE
|
4 percentage of subjects
|
3 percentage of subjects
|
6 percentage of subjects
|
|
Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs
Severe AE
|
4.2 percentage of subjects
|
5.0 percentage of subjects
|
6.0 percentage of subjects
|
|
Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs
Serious AE
|
0.4 percentage of subjects
|
0.4 percentage of subjects
|
0.7 percentage of subjects
|
SECONDARY outcome
Timeframe: Weeks 0 -12Outcome measures
| Measure |
Placebo
n=283 Participants
Placebo: placebo - one dose per nostril
|
Ciclesonide Nasal Aerosol 37mcg
n=282 Participants
ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
|
Ciclesonide Nasal Aerosol 74 mcg
n=281 Participants
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
|
|---|---|---|---|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
ACUTE SINUSITIS
|
1 participants
|
2 participants
|
1 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
APPLICATION SITE PAIN
|
3 participants
|
3 participants
|
1 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
EPISTAXIS
|
26 participants
|
20 participants
|
26 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
FACE INJURY
|
2 participants
|
1 participants
|
4 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
INCREASED UPPER AIRWAY SECRETION
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
MUCOSAL DISCOLOURATION
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
MUCOSAL EXCORIATION
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
MUCOSAL HAEMORRHAGE
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NASAL CONGESTION
|
0 participants
|
3 participants
|
1 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NASAL DISCOMFORT
|
6 participants
|
4 participants
|
8 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NASAL DRYNESS
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NASAL MUCOSAL DISCOLOURATION
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NASAL MUCOSAL DISORDER
|
4 participants
|
0 participants
|
2 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NASAL OEDEMA
|
4 participants
|
3 participants
|
3 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NASAL SEPTUM DISORDER
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NASAL SEPTUM ULCERATION
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NASAL TURBINATE ABNORMALITY
|
1 participants
|
1 participants
|
2 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NASAL ULCER
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
POSTNASAL DRIP
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
RHINALGIA
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
RHINITIS PERENNIAL
|
4 participants
|
0 participants
|
1 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
RHINORRHOEA
|
2 participants
|
1 participants
|
1 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
SCAB
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
SCRATCH
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
SINUS HEADACHE
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
SINUSITIS
|
5 participants
|
6 participants
|
4 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
SNEEZING
|
7 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Weeks 0 -12Outcome measures
| Measure |
Placebo
n=283 Participants
Placebo: placebo - one dose per nostril
|
Ciclesonide Nasal Aerosol 37mcg
n=282 Participants
ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
|
Ciclesonide Nasal Aerosol 74 mcg
n=281 Participants
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
|
|---|---|---|---|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
ACUTE SINUSITIS
|
0.4 percentage of subjects
|
0.7 percentage of subjects
|
0.4 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
APPLICATION SITE PAIN
|
1.1 percentage of subjects
|
1.1 percentage of subjects
|
0.4 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
EPISTAXIS
|
9.2 percentage of subjects
|
7.1 percentage of subjects
|
9.3 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
FACE INJURY
|
0.7 percentage of subjects
|
0.4 percentage of subjects
|
1.4 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
INCREASED UPPER AIRWAY SECRETION
|
0.4 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
MUCOSAL DISCOLOURATION
|
0.4 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
MUCOSAL EXCORIATION
|
0 percentage of subjects
|
0.4 percentage of subjects
|
0 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
MUCOSAL HAEMORRHAGE
|
0 percentage of subjects
|
0 percentage of subjects
|
0.4 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NASAL CONGESTION
|
0 percentage of subjects
|
1.1 percentage of subjects
|
0.4 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NASAL DISCOMFORT
|
2.1 percentage of subjects
|
1.4 percentage of subjects
|
2.8 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NASAL DRYNESS
|
0 percentage of subjects
|
0 percentage of subjects
|
0.4 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NASAL MUCOSAL DISCOLOURATION
|
0 percentage of subjects
|
0.4 percentage of subjects
|
0 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NASAL MUCOSAL DISORDER
|
1.4 percentage of subjects
|
0 percentage of subjects
|
0.7 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NASAL OEDEMA
|
1.4 percentage of subjects
|
1.1 percentage of subjects
|
1.1 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NASAL SEPTUM DISORDER
|
0 percentage of subjects
|
0.4 percentage of subjects
|
0.4 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NASAL SEPTUM ULCERATION
|
0.4 percentage of subjects
|
0 percentage of subjects
|
0.4 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NASAL TURBINATE ABNORMALITY
|
0.4 percentage of subjects
|
0.4 percentage of subjects
|
0.7 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NASAL ULCER
|
0 percentage of subjects
|
0 percentage of subjects
|
0.4 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
POSTNASAL DRIP
|
0 percentage of subjects
|
0.4 percentage of subjects
|
0.4 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
RHINALGIA
|
0 percentage of subjects
|
0 percentage of subjects
|
0.4 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
RHINITIS PERENNIAL
|
1.4 percentage of subjects
|
0 percentage of subjects
|
0.4 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
RHINORRHOEA
|
0.7 percentage of subjects
|
0.4 percentage of subjects
|
0.4 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
SCAB
|
0.4 percentage of subjects
|
0 percentage of subjects
|
0.7 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
SCRATCH
|
0.4 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
SINUS HEADACHE
|
0 percentage of subjects
|
0.4 percentage of subjects
|
0.4 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
SINUSITIS
|
1.8 percentage of subjects
|
2.1 percentage of subjects
|
1.4 percentage of subjects
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
SNEEZING
|
2.5 percentage of subjects
|
0.4 percentage of subjects
|
0 percentage of subjects
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 83 other events
Deaths: 0 deaths
Ciclesonide Nasal Aerosol 37mcg
Serious events: 1 serious events
Other events: 95 other events
Deaths: 0 deaths
Ciclesonide Nasal Aerosol 74 mcg
Serious events: 2 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=283 participants at risk
Placebo: placebo - one dose per nostril
|
Ciclesonide Nasal Aerosol 37mcg
n=282 participants at risk
ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
|
Ciclesonide Nasal Aerosol 74 mcg
n=281 participants at risk
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
|
|---|---|---|---|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/283 • 0-12 weeks
|
0.35%
1/282 • Number of events 1 • 0-12 weeks
|
0.00%
0/281 • 0-12 weeks
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/283 • 0-12 weeks
|
0.00%
0/282 • 0-12 weeks
|
0.36%
1/281 • Number of events 1 • 0-12 weeks
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/283 • 0-12 weeks
|
0.00%
0/282 • 0-12 weeks
|
0.36%
1/281 • Number of events 1 • 0-12 weeks
|
|
Infections and infestations
INFLUENZA
|
0.35%
1/283 • Number of events 1 • 0-12 weeks
|
0.00%
0/282 • 0-12 weeks
|
0.00%
0/281 • 0-12 weeks
|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.35%
1/283 • Number of events 1 • 0-12 weeks
|
0.00%
0/282 • 0-12 weeks
|
0.00%
0/281 • 0-12 weeks
|
Other adverse events
| Measure |
Placebo
n=283 participants at risk
Placebo: placebo - one dose per nostril
|
Ciclesonide Nasal Aerosol 37mcg
n=282 participants at risk
ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
|
Ciclesonide Nasal Aerosol 74 mcg
n=281 participants at risk
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
|
|---|---|---|---|
|
General disorders
PYREXIA
|
4.2%
12/283 • Number of events 13 • 0-12 weeks
|
6.4%
18/282 • Number of events 20 • 0-12 weeks
|
6.0%
17/281 • Number of events 17 • 0-12 weeks
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
6.4%
18/283 • Number of events 20 • 0-12 weeks
|
8.5%
24/282 • Number of events 25 • 0-12 weeks
|
8.9%
25/281 • Number of events 29 • 0-12 weeks
|
|
Nervous system disorders
HEADACHE
|
8.8%
25/283 • Number of events 42 • 0-12 weeks
|
11.0%
31/282 • Number of events 44 • 0-12 weeks
|
8.9%
25/281 • Number of events 38 • 0-12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
6.7%
19/283 • Number of events 22 • 0-12 weeks
|
7.4%
21/282 • Number of events 25 • 0-12 weeks
|
5.3%
15/281 • Number of events 22 • 0-12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
9.2%
26/283 • Number of events 42 • 0-12 weeks
|
7.1%
20/282 • Number of events 25 • 0-12 weeks
|
9.3%
26/281 • Number of events 45 • 0-12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
6.0%
17/283 • Number of events 19 • 0-12 weeks
|
5.3%
15/282 • Number of events 16 • 0-12 weeks
|
3.6%
10/281 • Number of events 14 • 0-12 weeks
|
Additional Information
Respiratory Medical Director
Sunovion
Phone: 1-866-503-6351
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish
- Publication restrictions are in place
Restriction type: OTHER