Trial Outcomes & Findings for A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Seasonal Allergic Rhinitis (SAR) (NCT NCT01458275)

NCT ID: NCT01458275

Last Updated: 2014-05-15

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 847 participants
• Primary outcome timeframe: Weeks 0 - 2
• Results posted on: 2014-05-15

Participant Flow

Participant milestones

Measure	Placebo Placebo: Placebo - one actuation 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 37 mcg	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
Overall Study STARTED	283	282	282
Overall Study COMPLETED	269	269	273
Overall Study NOT COMPLETED	14	13	9

Reasons for withdrawal

Measure	Placebo Placebo: Placebo - one actuation 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 37 mcg	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
Overall Study Adverse Event	3	4	1
Overall Study Lost to Follow-up	3	2	5
Overall Study Protocol Violation	5	5	2
Overall Study Withdrawal by Subject	3	2	1

Baseline Characteristics

A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Seasonal Allergic Rhinitis (SAR)

Baseline characteristics by cohort

Measure	Placebo n=283 Participants Placebo: Placebo - one actuation 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 37 mcg	Ciclesonide Nasal Aerosol 74 mcg n=282 Participants ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg	Total n=847 Participants Total of all reporting groups
Age, Categorical <=18 years	283 Participants n=5 Participants	282 Participants n=7 Participants	282 Participants n=5 Participants	847 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
Age, Continuous	8.6 years STANDARD_DEVIATION 1.72 • n=5 Participants	8.5 years STANDARD_DEVIATION 1.64 • n=7 Participants	8.7 years STANDARD_DEVIATION 1.65 • n=5 Participants	8.6 years STANDARD_DEVIATION 1.65 • n=4 Participants
Age, Customized 6-8 Years	131 participants n=5 Participants	123 participants n=7 Participants	120 participants n=5 Participants	374 participants n=4 Participants
Age, Customized 9-11 Years	152 participants n=5 Participants	159 participants n=7 Participants	162 participants n=5 Participants	473 participants n=4 Participants
Sex: Female, Male Female	131 Participants n=5 Participants	123 Participants n=7 Participants	120 Participants n=5 Participants	374 Participants n=4 Participants
Sex: Female, Male Male	152 Participants n=5 Participants	159 Participants n=7 Participants	162 Participants n=5 Participants	473 Participants n=4 Participants
Region of Enrollment United States	283 participants n=5 Participants	282 participants n=7 Participants	282 participants n=5 Participants	847 participants n=4 Participants

PRIMARY outcome

Timeframe: Weeks 0 - 2

Population: n = number of ITT subjects in treatmentgroup with completed assessment

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	Placebo n=280 Participants Placebo: Placebo - one actuation per nostril	Ciclesonide Nasal Aerosol 37mcg n=279 Participants ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg	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
Change From Baseline in Average Daily Subject Reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period	-1.63 units on a scale Standard Error 0.133	-1.73 units on a scale Standard Error 0.133	-1.61 units on a scale Standard Error 0.133

SECONDARY outcome

Timeframe: Weeks 0 - 2

Population: n = number of ITT subjects in treatment group with completed assessment

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	Placebo n=278 Participants Placebo: Placebo - one actuation 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 37 mcg	Ciclesonide Nasal Aerosol 74 mcg n=280 Participants ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period	-1.32 units on a scale Standard Error 0.125	-1.48 units on a scale Standard Error 0.125	-1.35 units on a scale Standard Error 0.125

SECONDARY outcome

Timeframe: Weeks 0 - 2

Population: n = number of ITT subjects in treatment group with completed assessment

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	Placebo n=279 Participants Placebo: Placebo - one actuation 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 37 mcg	Ciclesonide Nasal Aerosol 74 mcg n=279 Participants ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Ocular Symptom Scores (rTOSS) Over the 2-week Double-blind Treatment Period.	-0.84 units on a scale Standard Error 0.090	-0.69 units on a scale Standard Error 0.090	-0.79 units on a scale Standard Error 0.090

SECONDARY outcome

Timeframe: Weeks 0 - 2

Population: n = number of ITT subjects in treatment group with completed assessment

PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses and the individual domain scores are the means of the items in those domains.

Outcome measures

Measure	Placebo n=278 Participants Placebo: Placebo - one actuation per nostril	Ciclesonide Nasal Aerosol 37mcg n=279 Participants ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg	Ciclesonide Nasal Aerosol 74 mcg n=279 Participants ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the Double-blind Treatment Period.	-0.41 units on a scale Standard Error 0.055	-0.43 units on a scale Standard Error 0.055	-0.51 units on a scale Standard Error 0.054

SECONDARY outcome

Timeframe: Weeks 0 - 2

Population: n = number of ITT subjects in treatment group with completed assessment

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions assessed in the AM. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe in the AM. Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Measure	Placebo n=278 Participants Placebo: Placebo - one actuation 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 37 mcg	Ciclesonide Nasal Aerosol 74 mcg n=279 Participants ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
Change From Baseline in Average Daily Subject Reported AM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period	-1.27 units on a scale Standard Error 0.126	-1.48 units on a scale Standard Error 0.126	-1.34 units on a scale Standard Error 0.126

SECONDARY outcome

Timeframe: Weeks 0 - 2

Population: n = number of ITT subjects in treatment group with completed assessment

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	Placebo n=279 Participants Placebo: Placebo - one actuation 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 37 mcg	Ciclesonide Nasal Aerosol 74 mcg n=279 Participants ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Ocular Symptom Scores (iTOSS) Over the 2-week Double-blind Treatment Period.	-0.71 units on a scale Standard Error 0.088	-0.57 units on a scale Standard Error 0.088	-0.66 units on a scale Standard Error 0.088

SECONDARY outcome

Timeframe: Weeks 0 - 2

The time to maximal effect, defined as the number of days until the first treatment day on which the estimated difference between ciclesonide nasal aerosol and placebo was at least 90% of the largest estimated difference, was based on the analyses of change from baseline in the average of AM and PM rTNSS scores for each day. The time to achieve at least 90% of these estimated differences is presented.

Outcome measures

Measure	Placebo n=282 Participants Placebo: Placebo - one actuation 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 37 mcg	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
Time to Maximal Effect in the AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period	2 Days	13 Days	—

SECONDARY outcome

Timeframe: Weeks 0 - 3

Treatment-Emergent Adverse Events Occurring in ≥ 2% of Subjects in Any Treatment Group (ITT Population)

Outcome measures

Measure	Placebo n=283 Participants Placebo: Placebo - one actuation 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 37 mcg	Ciclesonide Nasal Aerosol 74 mcg n=282 Participants ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
Number of Subjects Experiencing Treatment-emergent AEs PYREXIA	4 participants	5 participants	7 participants
Number of Subjects Experiencing Treatment-emergent AEs HEADACHE	9 participants	14 participants	10 participants
Number of Subjects Experiencing Treatment-emergent AEs COUGH	6 participants	4 participants	4 participants
Number of Subjects Experiencing Treatment-emergent AEs EPISTAXIS	10 participants	12 participants	6 participants

SECONDARY outcome

Timeframe: Weeks 0 - 3

Treatment-Emergent Adverse Events Occurring in ≥ 2% of Subjects in Any Treatment Group (ITT Population)

Outcome measures

Measure	Placebo n=283 Participants Placebo: Placebo - one actuation 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 37 mcg	Ciclesonide Nasal Aerosol 74 mcg n=282 Participants ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
Percentage of Subjects Experiencing Treatment-emergent AEs HEADACHE	3.2 Percentage of participants	5.0 Percentage of participants	3.5 Percentage of participants
Percentage of Subjects Experiencing Treatment-emergent AEs COUGH	2.1 Percentage of participants	1.4 Percentage of participants	1.4 Percentage of participants
Percentage of Subjects Experiencing Treatment-emergent AEs PYREXIA	1.4 Percentage of participants	1.8 Percentage of participants	2.5 Percentage of participants
Percentage of Subjects Experiencing Treatment-emergent AEs EPISTAXIS	3.5 Percentage of participants	4.3 Percentage of participants	2.1 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 0 - 3

Outcome measures

Measure	Placebo n=283 Participants Placebo: Placebo - one actuation 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 37 mcg	Ciclesonide Nasal Aerosol 74 mcg n=282 Participants ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
Treatment-emergent AEs Causing Study Medication Discontinuation Application site pain	0 participants	0 participants	1 participants
Treatment-emergent AEs Causing Study Medication Discontinuation Hypersensitivity	0 participants	1 participants	0 participants
Treatment-emergent AEs Causing Study Medication Discontinuation Pharyngitis streptococcal	0 participants	1 participants	0 participants
Treatment-emergent AEs Causing Study Medication Discontinuation Allergic respiratory symptom	1 participants	0 participants	0 participants
Treatment-emergent AEs Causing Study Medication Discontinuation Asthma	1 participants	2 participants	0 participants
Treatment-emergent AEs Causing Study Medication Discontinuation Rhinitis seasonal	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Weeks 0 - 3

Outcome measures

Measure	Placebo n=283 Participants Placebo: Placebo - one actuation 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 37 mcg	Ciclesonide Nasal Aerosol 74 mcg n=282 Participants ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Mucosal excoriation	1 participants	0 participants	0 participants
Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Mucosal haemorrhage	0 participants	1 participants	0 participants
Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Acute sinusits	0 participants	1 participants	1 participants
Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Application site burn	1 participants	0 participants	0 participants
Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Application site pain	3 participants	4 participants	3 participants
Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Epistaxis	10 participants	12 participants	6 participants
Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Mucosal erosion	0 participants	1 participants	0 participants
Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Nasal congestion	1 participants	0 participants	0 participants
Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Nasal discomfort	0 participants	5 participants	0 participants
Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Nasal dryness	0 participants	0 participants	1 participants
Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Nasal mucosal disorder	1 participants	1 participants	0 participants
Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Nasal septum ulceration	0 participants	0 participants	1 participants
Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Rhinalgia	1 participants	0 participants	0 participants
Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Rhinitis seasonal	1 participants	1 participants	0 participants
Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Scab	0 participants	1 participants	0 participants
Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Scratch	1 participants	0 participants	0 participants
Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Sinus headache	1 participants	0 participants	0 participants
Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Sinus lesion	1 participants	0 participants	0 participants
Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Sneezing	0 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Weeks 0 - 3

Outcome measures

Measure	Placebo n=283 Participants Placebo: Placebo - one actuation 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 37 mcg	Ciclesonide Nasal Aerosol 74 mcg n=282 Participants ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Acute sinusits	0 Percentage of participants	0.4 Percentage of participants	0.4 Percentage of participants
Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Application site burn	0.4 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Application site pain	1.1 Percentage of participants	1.4 Percentage of participants	1.1 Percentage of participants
Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Epistaxis	3.5 Percentage of participants	4.3 Percentage of participants	2.1 Percentage of participants
Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Mucosal erosion	0 Percentage of participants	0.4 Percentage of participants	0 Percentage of participants
Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Mucosal excoriation	0.4 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Mucosal haemorrhage	0 Percentage of participants	0.4 Percentage of participants	0 Percentage of participants
Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Nasal congestion	0.4 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Nasal discomfort	0 Percentage of participants	1.8 Percentage of participants	0 Percentage of participants
Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Nasal dryness	0 Percentage of participants	0 Percentage of participants	0.4 Percentage of participants
Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Nasal mucosal disorder	0.4 Percentage of participants	0.4 Percentage of participants	0 Percentage of participants
Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Nasal septum ulceration	0 Percentage of participants	0 Percentage of participants	0.4 Percentage of participants
Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Rhinalgia	0.4 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Rhinitis seasonal	0.4 Percentage of participants	0.4 Percentage of participants	0 Percentage of participants
Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Scab	0 Percentage of participants	0.4 Percentage of participants	0 Percentage of participants
Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Scratch	0.4 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Sinus headache	0.4 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Sinus lesion	0.4 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Sneezing	0 Percentage of participants	0 Percentage of participants	0.4 Percentage of participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Ciclesonide Nasal Aerosol 37mcg

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

Ciclesonide Nasal Aerosol 74 mcg

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=283 participants at risk Placebo: Placebo - one actuation 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 37 mcg	Ciclesonide Nasal Aerosol 74 mcg n=282 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
Infections and infestations APPENDICITIS	0.00% 0/283 • Weeks 0 to 3	0.35% 1/282 • Number of events 1 • Weeks 0 to 3	0.00% 0/282 • Weeks 0 to 3

Other adverse events

Measure	Placebo n=283 participants at risk Placebo: Placebo - one actuation 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 37 mcg	Ciclesonide Nasal Aerosol 74 mcg n=282 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
Skin and subcutaneous tissue disorders PYREXIA	1.4% 4/283 • Number of events 4 • Weeks 0 to 3	1.8% 5/282 • Number of events 5 • Weeks 0 to 3	2.5% 7/282 • Number of events 7 • Weeks 0 to 3
Nervous system disorders HEADACHE	3.2% 9/283 • Number of events 12 • Weeks 0 to 3	5.0% 14/282 • Number of events 15 • Weeks 0 to 3	3.5% 10/282 • Number of events 10 • Weeks 0 to 3
Respiratory, thoracic and mediastinal disorders COUGH	2.1% 6/283 • Number of events 6 • Weeks 0 to 3	1.4% 4/282 • Number of events 4 • Weeks 0 to 3	1.4% 4/282 • Number of events 4 • Weeks 0 to 3
Respiratory, thoracic and mediastinal disorders EPISTAXIS	3.5% 10/283 • Number of events 12 • Weeks 0 to 3	4.3% 12/282 • Number of events 17 • Weeks 0 to 3	2.1% 6/282 • Number of events 7 • Weeks 0 to 3

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