Trial Outcomes & Findings for Study of the Effects of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol on Hypothalamic-Pituitary-Adrenal (HPA) Axis (NCT NCT01033825)

NCT ID: NCT01033825

Last Updated: 2012-07-19

Results Overview

AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 310 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2012-07-19

Participant Flow

Participant milestones

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg Ciclesonide HFA Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg Ciclesonide Aqueous Nasal Spray 200 mcg once daily	AQ Nasal Spray Placebo AQ Nasal Spray Placebo once daily	Placebo HFA Plus Dexamethasone 6 mg Placebo HFA plus Dexamethasone 6 mg once daily. Placebo is the study control \& used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of the placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.	Placebo AQ Plus Dexamethasone 6 mg Placebo AQ plus Dexamethasone 6 mg once daily. Placebo is the study control \& used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of these placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
Overall Study STARTED	51	60	57	48	58	18	18
Overall Study COMPLETED	48	57	55	46	56	18	18
Overall Study NOT COMPLETED	3	3	2	2	2	0	0

Reasons for withdrawal

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg Ciclesonide HFA Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg Ciclesonide Aqueous Nasal Spray 200 mcg once daily	AQ Nasal Spray Placebo AQ Nasal Spray Placebo once daily	Placebo HFA Plus Dexamethasone 6 mg Placebo HFA plus Dexamethasone 6 mg once daily. Placebo is the study control \& used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of the placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.	Placebo AQ Plus Dexamethasone 6 mg Placebo AQ plus Dexamethasone 6 mg once daily. Placebo is the study control \& used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of these placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
Overall Study Withdrawal by Subject	2	3	2	1	1	0	0
Overall Study Adverse Event	0	0	0	1	0	0	0
Overall Study Protocol Violation	1	0	0	0	0	0	0
Overall Study Other	0	0	0	0	1	0	0

Baseline Characteristics

Study of the Effects of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol on Hypothalamic-Pituitary-Adrenal (HPA) Axis

Baseline characteristics by cohort

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=51 Participants Ciclesonide HFA Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous Nasal Spray 200 mcg once daily	AQ Nasal Spray Placebo n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus Dexamethasone 6 mg n=18 Participants Placebo HFA plus Dexamethasone 6 mg once daily. Placebo is the study control \& used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of the placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.	Placebo AQ Plus Dexamethasone 6 mg n=18 Participants Placebo AQ plus Dexamethasone 6 mg once daily. Placebo is the study control \& used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of these placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.	Total n=310 Participants Total of all reporting groups
Age, Categorical <=18 years	4 Participants n=93 Participants	10 Participants n=4 Participants	12 Participants n=27 Participants	8 Participants n=483 Participants	9 Participants n=36 Participants	2 Participants n=10 Participants	3 Participants n=115 Participants	48 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=93 Participants	50 Participants n=4 Participants	43 Participants n=27 Participants	40 Participants n=483 Participants	48 Participants n=36 Participants	16 Participants n=10 Participants	15 Participants n=115 Participants	259 Participants n=40 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	3 Participants n=40 Participants
Age Continuous	35.8 years STANDARD_DEVIATION 13.62 • n=93 Participants	34.5 years STANDARD_DEVIATION 13.42 • n=4 Participants	33.0 years STANDARD_DEVIATION 15.69 • n=27 Participants	32.3 years STANDARD_DEVIATION 12.53 • n=483 Participants	35.5 years STANDARD_DEVIATION 14.55 • n=36 Participants	35.4 years STANDARD_DEVIATION 12.94 • n=10 Participants	34.0 years STANDARD_DEVIATION 134.41 • n=115 Participants	34.26 years STANDARD_DEVIATION 14.01 • n=40 Participants
Sex: Female, Male Female	32 Participants n=93 Participants	37 Participants n=4 Participants	37 Participants n=27 Participants	30 Participants n=483 Participants	33 Participants n=36 Participants	6 Participants n=10 Participants	12 Participants n=115 Participants	187 Participants n=40 Participants
Sex: Female, Male Male	19 Participants n=93 Participants	23 Participants n=4 Participants	20 Participants n=27 Participants	18 Participants n=483 Participants	25 Participants n=36 Participants	12 Participants n=10 Participants	6 Participants n=115 Participants	123 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=93 Participants	16 Participants n=4 Participants	6 Participants n=27 Participants	11 Participants n=483 Participants	10 Participants n=36 Participants	3 Participants n=10 Participants	3 Participants n=115 Participants	60 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=93 Participants	44 Participants n=4 Participants	51 Participants n=27 Participants	37 Participants n=483 Participants	48 Participants n=36 Participants	15 Participants n=10 Participants	15 Participants n=115 Participants	250 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants
Race/Ethnicity, customized White/Caucasian	49 particpants n=93 Participants	51 particpants n=4 Participants	52 particpants n=27 Participants	42 particpants n=483 Participants	52 particpants n=36 Participants	15 particpants n=10 Participants	15 particpants n=115 Participants	276 particpants n=40 Participants
Race/Ethnicity, customized Black or African American	1 particpants n=93 Participants	4 particpants n=4 Participants	5 particpants n=27 Participants	4 particpants n=483 Participants	5 particpants n=36 Participants	2 particpants n=10 Participants	1 particpants n=115 Participants	22 particpants n=40 Participants
Race/Ethnicity, customized Asian	1 particpants n=93 Participants	5 particpants n=4 Participants	0 particpants n=27 Participants	0 particpants n=483 Participants	0 particpants n=36 Participants	0 particpants n=10 Participants	0 particpants n=115 Participants	6 particpants n=40 Participants
Race/Ethnicity, customized American Indian or Alaska Native	0 particpants n=93 Participants	0 particpants n=4 Participants	0 particpants n=27 Participants	1 particpants n=483 Participants	1 particpants n=36 Participants	0 particpants n=10 Participants	0 particpants n=115 Participants	2 particpants n=40 Participants
Race/Ethnicity, customized Native Hawaiian or Other Pacific Islander	0 particpants n=93 Participants	0 particpants n=4 Participants	0 particpants n=27 Participants	0 particpants n=483 Participants	0 particpants n=36 Participants	0 particpants n=10 Participants	0 particpants n=115 Participants	0 particpants n=40 Participants
Race/Ethnicity, customized Other	0 particpants n=93 Participants	0 particpants n=4 Participants	0 particpants n=27 Participants	0 particpants n=483 Participants	0 particpants n=36 Participants	0 particpants n=10 Participants	1 particpants n=115 Participants	1 particpants n=40 Participants
Race/Ethnicity, customized Multiple	0 particpants n=93 Participants	0 particpants n=4 Participants	0 particpants n=27 Participants	1 particpants n=483 Participants	0 particpants n=36 Participants	1 particpants n=10 Participants	1 particpants n=115 Participants	3 particpants n=40 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE).

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=50 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline	183.2 mcg•h/dL Standard Deviation 61.9	171.7 mcg•h/dL Standard Deviation 40.1	173.1 mcg•h/dL Standard Deviation 53.5	172.8 mcg•h/dL Standard Deviation 42.5	179.0 mcg•h/dL Standard Deviation 37.9	—	—

PRIMARY outcome

Timeframe: week 6

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

Change is calculated as week 6 minus baseline. AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE).

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=50 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
The Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) From Baseline to Week 6 of the Double Blind Treatment Period	-4.6 mcg•h/dL Standard Error 5.0	-2.6 mcg•h/dL Standard Error 4.6	-5.0 mcg•h/dL Standard Error 4.6	-11.4 mcg•h/dL Standard Error 5.7	-1.0 mcg•h/dL Standard Error 5.2	—	—

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Intent to Treat Population.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=51 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=75 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=76 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Number of Subjects Experiencing Adverse Events (AEs)	23 participants	17 participants	23 participants	19 participants	29 participants	—	—

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Intent to Treat Population.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=51 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=75 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=76 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Percentage of Subjects Experiencing Adverse Events (AEs)	45.1 percentage of subjects	28.3 percentage of subjects	30.7 percentage of subjects	39.6 percentage of subjects	38.2 percentage of subjects	—	—

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Intent to Treat Population.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=48 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=57 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=75 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=47 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=76 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Number of Subjects Experiencing Serious Adverse Events (SAEs).	0 participants	0 participants	0 participants	0 participants	0 participants	—	—

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Intent to Treat Population

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=48 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=57 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=75 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=47 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=76 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Percentage of Subjects Experiencing Serious Adverse Events (SAEs).	0 percentage of subjects	0 percentage of subjects	0 percentage of subjects	0 percentage of subjects	0 percentage of subjects	—	—

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Intent to Treat Population.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=51 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=75 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=76 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Number of Subjects Who Discontinue Due to AEs	0 participants	0 participants	0 participants	1 participants	0 participants	—	—

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Intent to Treat Population

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=48 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=57 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=75 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=47 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=76 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Percentage of Subjects Who Discontinue Due to AEs	0 percentage of subjects	0 percentage of subjects	0 percentage of subjects	2.1 percentage of subjects	0 percentage of subjects	—	—

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Intent to Treat Population

Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=51 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone n=18 Participants Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone n=18 Participants Placebo AQ plus 6 mg Dexamethasone once daily
Number of Subjects Experiencing Local Nasal AEs	21 participants	11 participants	8 participants	16 participants	11 participants	5 participants	1 participants

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Intent to Treat Population

Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=51 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone n=18 Participants Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone n=18 Participants Placebo AQ plus 6 mg Dexamethasone once daily
Percentage of Subjects Experiencing Local Nasal AEs	41.2 percentage of subjects	18.3 percentage of subjects	14.0 percentage of subjects	33.3 percentage of subjects	19.0 percentage of subjects	27.8 percentage of subjects	5.6 percentage of subjects

SECONDARY outcome

Timeframe: Baseline

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=51 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline	99.8 mcg•h/dL Standard Deviation 38.3	95.1 mcg•h/dL Standard Deviation 28.5	92.0 mcg•h/dL Standard Deviation 31.3	91.9 mcg•h/dL Standard Deviation 25.8	97.2 mcg•h/dL Standard Deviation 25.0	—	—

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=51 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment	-1.0 mcg•h/dL Standard Error 3.2	-1.3 mcg•h/dL Standard Error 3.0	0.5 mcg•h/dL Standard Error 3.0	-5.8 mcg•h/dL Standard Error 3.0	-2.9 mcg•h/dL Standard Error 2.7	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=51 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline	83.4 mcg•h/dL Standard Deviation 30.2	76.2 mcg•h/dL Standard Deviation 24.0	81.1 mcg•h/dL Standard Deviation 28.7	80.9 mcg•h/dL Standard Deviation 26.8	81.8 mcg•h/dL Standard Deviation 22.8	—	—

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=51 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment	-3.9 mcg•h/dL Standard Error 2.9	-2.0 mcg•h/dL Standard Error 2.7	-5.9 mcg•h/dL Standard Error 2.7	-6.1 mcg•h/dL Standard Error 3.7	2.2 mcg•h/dL Standard Error 3.4	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 Nasal Aerosol 320 Mcg n=50 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=59 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Baseline Daily Subject-reported AM Reflective TNSS	7.55 units on a scale Standard Deviation 2.39	8.03 units on a scale Standard Deviation 2.27	7.81 units on a scale Standard Deviation 2.47	7.91 units on a scale Standard Deviation 2.50	7.84 units on a scale Standard Deviation 2.58	—	—

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 Nasal Aerosol 320 Mcg n=50 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=59 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment	-1.80 units on a scale Standard Error 0.29	-1.75 units on a scale Standard Error 0.26	-0.35 units on a scale Standard Error 0.27	-1.18 units on a scale Standard Error 0.30	-0.91 units on a scale Standard Error 0.28	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 Nasal Aerosol 320 Mcg n=50 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=59 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Baseline Daily Subject-reported PM Reflective TNSS	7.82 units on a scale Standard Deviation 2.40	8.39 units on a scale Standard Deviation 2.11	7.83 units on a scale Standard Deviation 2.52	8.13 units on a scale Standard Deviation 2.66	8.16 units on a scale Standard Deviation 2.51	—	—

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 Nasal Aerosol 320 Mcg n=50 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=59 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment	-1.77 units on a scale Standard Error 0.30	-1.88 units on a scale Standard Error 0.28	-0.31 units on a scale Standard Error 0.28	-1.14 units on a scale Standard Error 0.29	-1.19 units on a scale Standard Error 0.26	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 Nasal Aerosol 320 Mcg n=50 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=59 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Baseline Daily Subject-reported AM Instantaneous TNSS	6.91 units on a scale Standard Deviation 2.68	7.63 units on a scale Standard Deviation 2.35	7.37 units on a scale Standard Deviation 2.68	7.24 units on a scale Standard Deviation 2.43	7.19 units on a scale Standard Deviation 2.84	—	—

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 Nasal Aerosol 320 Mcg n=50 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=59 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment	-1.52 units on a scale Standard Error 0.27	-1.62 units on a scale Standard Error 0.25	-0.26 units on a scale Standard Error 0.25	-1.23 units on a scale Standard Error 0.29	-0.60 units on a scale Standard Error 0.26	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 Nasal Aerosol 320 Mcg n=51 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Baseline Daily Subject-reported AM and PM Reflective TNSS	7.68 units on a scale Standard Deviation 2.33	8.20 units on a scale Standard Deviation 2.14	7.82 units on a scale Standard Deviation 2.45	8.01 units on a scale Standard Deviation 2.52	8.01 units on a scale Standard Deviation 2.49	—	—

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 Nasal Aerosol 320 Mcg n=51 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over Each Week, and Averaged Over the 6 Weeks of Double-blind Treatment	-1.78 units on a scale Standard Error 0.29	-1.82 units on a scale Standard Error 0.27	-0.33 units on a scale Standard Error 0.27	-1.16 units on a scale Standard Error 0.29	-1.06 units on a scale Standard Error 0.27	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 Nasal Aerosol 320 Mcg n=50 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=59 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Baseline Daily Subject-reported PM Instantaneous TNSS	6.84 units on a scale Standard Deviation 3.09	7.60 units on a scale Standard Deviation 2.37	7.13 units on a scale Standard Deviation 2.75	7.38 units on a scale Standard Deviation 2.68	7.44 units on a scale Standard Deviation 2.74	—	—

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 Nasal Aerosol 320 Mcg n=50 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=59 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment	-1.39 units on a scale Standard Error 0.28	-1.67 units on a scale Standard Error 0.26	-0.10 units on a scale Standard Error 0.26	-1.09 units on a scale Standard Error 0.30	-0.88 units on a scale Standard Error 0.28	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 Nasal Aerosol 320 Mcg n=51 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Baseline Daily Subject-reported AM and PM Instantaneous TNSS	6.87 units on a scale Standard Deviation 2.84	7.62 units on a scale Standard Deviation 2.29	7.26 units on a scale Standard Deviation 2.67	7.30 units on a scale Standard Deviation 2.52	7.33 units on a scale Standard Deviation 2.74	—	—

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 Nasal Aerosol 320 Mcg n=51 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment	-1.45 units on a scale Standard Error 0.27	-1.67 units on a scale Standard Error 0.25	-0.19 units on a scale Standard Error 0.25	-1.15 units on a scale Standard Error 0.29	-0.75 units on a scale Standard Error 0.27	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);

1. = mild

2. = moderate

3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=50 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=59 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Baseline Daily Subject-reported Individual AM Reflective NSS Baseline Nasal Sneezing	1.56 units on a scale Standard Deviation 0.83	1.65 units on a scale Standard Deviation 0.88	1.54 units on a scale Standard Deviation 0.89	1.42 units on a scale Standard Deviation 0.81	1.57 units on a scale Standard Deviation 0.93	—	—
Baseline Daily Subject-reported Individual AM Reflective NSS Baseline Runny Nose	1.99 units on a scale Standard Deviation 0.68	2.16 units on a scale Standard Deviation 0.63	2.15 units on a scale Standard Deviation 0.70	2.27 units on a scale Standard Deviation 0.71	2.06 units on a scale Standard Deviation 0.76	—	—
Baseline Daily Subject-reported Individual AM Reflective NSS Baseline Nasal Itching	1.71 units on a scale Standard Deviation 0.85	1.89 units on a scale Standard Deviation 0.75	1.83 units on a scale Standard Deviation 0.83	1.85 units on a scale Standard Deviation 0.85	1.92 units on a scale Standard Deviation 0.83	—	—
Baseline Daily Subject-reported Individual AM Reflective NSS Baseline Nasal Congestion	2.30 units on a scale Standard Deviation 0.59	2.32 units on a scale Standard Deviation 0.57	2.29 units on a scale Standard Deviation 0.60	2.36 units on a scale Standard Deviation 0.66	2.29 units on a scale Standard Deviation 0.62	—	—

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);

1. = mild

2. = moderate

3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=50 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=59 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period Nasal Sneezing	-0.41 units on a scale Standard Error 0.09	-0.41 units on a scale Standard Error 0.08	-0.09 units on a scale Standard Error 0.08	-0.28 units on a scale Standard Error 0.08	-0.25 units on a scale Standard Error 0.08	—	—
Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period Runny Nose	-0.50 units on a scale Standard Error 0.08	-0.50 units on a scale Standard Error 0.08	-0.17 units on a scale Standard Error 0.08	-0.36 units on a scale Standard Error 0.10	-0.29 units on a scale Standard Error 0.09	—	—
Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period Nasal Itching	-0.40 units on a scale Standard Error 0.08	-0.40 units on a scale Standard Error 0.08	-0.05 units on a scale Standard Error 0.08	-0.33 units on a scale Standard Error 0.09	-0.25 units on a scale Standard Error 0.08	—	—
Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period Nasal Congestion	-0.49 units on a scale Standard Error 0.07	-0.42 units on a scale Standard Error 0.07	-0.05 units on a scale Standard Error 0.07	-0.20 units on a scale Standard Error 0.09	-0.13 units on a scale Standard Error 0.08	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);

1. = mild

2. = moderate

3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=50 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=59 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Baseline Daily Subject-reported Individual PM Reflective NSS Baseline Nasal Sneezing	1.82 units on a scale Standard Deviation 0.71	1.87 units on a scale Standard Deviation 0.76	1.69 units on a scale Standard Deviation 0.81	1.59 units on a scale Standard Deviation 0.83	1.74 units on a scale Standard Deviation 0.87	—	—
Baseline Daily Subject-reported Individual PM Reflective NSS Baseline Runny Nose	2.03 units on a scale Standard Deviation 0.66	2.20 units on a scale Standard Deviation 0.58	2.11 units on a scale Standard Deviation 0.71	2.30 units on a scale Standard Deviation 0.74	2.16 units on a scale Standard Deviation 0.73	—	—
Baseline Daily Subject-reported Individual PM Reflective NSS Baseline Nasal Itching	1.75 units on a scale Standard Deviation 0.83	2.02 units on a scale Standard Deviation 0.75	1.80 units on a scale Standard Deviation 0.82	1.93 units on a scale Standard Deviation 0.87	2.00 units on a scale Standard Deviation 0.78	—	—
Baseline Daily Subject-reported Individual PM Reflective NSS Baseline Nasal Congestion	2.23 units on a scale Standard Deviation 0.72	2.30 units on a scale Standard Deviation 0.54	2.23 units on a scale Standard Deviation 0.67	2.31 units on a scale Standard Deviation 0.73	2.25 units on a scale Standard Deviation 0.63	—	—

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);

1. = mild

2. = moderate

3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=50 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=59 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period Nasal Sneezing	-0.45 units on a scale Standard Error 0.09	-0.48 units on a scale Standard Error 0.08	-0.13 units on a scale Standard Error 0.08	-0.23 units on a scale Standard Error 0.08	-0.27 units on a scale Standard Error 0.08	—	—
Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period Runny Nose	-0.49 units on a scale Standard Error 0.08	-0.48 units on a scale Standard Error 0.08	-0.09 units on a scale Standard Error 0.08	-0.37 units on a scale Standard Error 0.09	-0.37 units on a scale Standard Error 0.08	—	—
Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period Nasal Itching	-0.38 units on a scale Standard Error 0.08	-0.46 units on a scale Standard Error 0.08	-0.05 units on a scale Standard Error 0.08	-0.32 units on a scale Standard Error 0.09	-0.34 units on a scale Standard Error 0.08	—	—
Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period Nasal Congestion	-0.44 units on a scale Standard Error 0.08	-0.44 units on a scale Standard Error 0.07	-0.04 units on a scale Standard Error 0.07	-0.20 units on a scale Standard Error 0.09	-0.21 units on a scale Standard Error 0.08	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);

1. = mild

2. = moderate

3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=51 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Baseline Daily Subject-reported Individual AM and PM Reflective NSS Baseline Nasal Sneezing	1.69 units on a scale Standard Deviation 0.73	1.76 units on a scale Standard Deviation 0.79	1.62 units on a scale Standard Deviation 0.83	1.51 units on a scale Standard Deviation 0.78	1.66 units on a scale Standard Deviation 0.87	—	—
Baseline Daily Subject-reported Individual AM and PM Reflective NSS Baseline Runny Nose	2.01 units on a scale Standard Deviation 0.65	2.18 units on a scale Standard Deviation 0.59	2.13 units on a scale Standard Deviation 0.69	2.29 units on a scale Standard Deviation 0.70	2.11 units on a scale Standard Deviation 0.72	—	—
Baseline Daily Subject-reported Individual AM and PM Reflective NSS Baseline Nasal Itching	1.73 units on a scale Standard Deviation 0.83	1.95 units on a scale Standard Deviation 0.73	1.82 units on a scale Standard Deviation 0.80	1.89 units on a scale Standard Deviation 0.85	1.96 units on a scale Standard Deviation 0.79	—	—
Baseline Daily Subject-reported Individual AM and PM Reflective NSS Baseline Nasal Congestion	2.26 units on a scale Standard Deviation 0.63	2.31 units on a scale Standard Deviation 0.53	2.26 units on a scale Standard Deviation 0.62	2.33 units on a scale Standard Deviation 0.67	2.27 units on a scale Standard Deviation 0.61	—	—

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);

1. = mild

2. = moderate

3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=51 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period Nasal Sneezing	-0.43 units on a scale Standard Error 0.09	-0.45 units on a scale Standard Error 0.08	-0.11 units on a scale Standard Error 0.08	-0.25 units on a scale Standard Error 0.08	-0.26 units on a scale Standard Error 0.07	—	—
Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period Runny Nose	-0.50 units on a scale Standard Error 0.08	-0.50 units on a scale Standard Error 0.07	-0.13 units on a scale Standard Error 0.08	-0.37 units on a scale Standard Error 0.09	-0.33 units on a scale Standard Error 0.08	—	—
Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period Nasal Itching	-0.39 units on a scale Standard Error 0.08	-0.43 units on a scale Standard Error 0.08	-0.05 units on a scale Standard Error 0.08	-0.32 units on a scale Standard Error 0.09	-0.30 units on a scale Standard Error 0.08	—	—
Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period Nasal Congestion	-0.47 units on a scale Standard Error 0.07	-0.43 units on a scale Standard Error 0.07	-0.04 units on a scale Standard Error 0.07	-0.20 units on a scale Standard Error 0.09	-0.17 units on a scale Standard Error 0.08	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);

1. = mild

2. = moderate

3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=50 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=59 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Baseline Daily Subject-reported Individual AM Instantaneous NSS Baseline Nasal Sneezing	1.24 units on a scale Standard Deviation 0.82	1.43 units on a scale Standard Deviation 0.96	1.34 units on a scale Standard Deviation 0.94	1.15 units on a scale Standard Deviation 0.85	1.30 units on a scale Standard Deviation 1.02	—	—
Baseline Daily Subject-reported Individual AM Instantaneous NSS Baseline Runny Nose	1.83 units on a scale Standard Deviation 0.84	2.08 units on a scale Standard Deviation 0.66	2.01 units on a scale Standard Deviation 0.74	2.08 units on a scale Standard Deviation 0.68	1.93 units on a scale Standard Deviation 0.89	—	—
Baseline Daily Subject-reported Individual AM Instantaneous NSS Baseline Nasal Itching	1.61 units on a scale Standard Deviation 0.86	1.85 units on a scale Standard Deviation 0.75	1.76 units on a scale Standard Deviation 0.89	1.76 units on a scale Standard Deviation 0.89	1.76 units on a scale Standard Deviation 0.91	—	—
Baseline Daily Subject-reported Individual AM Instantaneous NSS Baseline Nasal Congestion	2.24 units on a scale Standard Deviation 0.67	2.27 units on a scale Standard Deviation 0.58	2.27 units on a scale Standard Deviation 0.60	2.25 units on a scale Standard Deviation 0.66	2.20 units on a scale Standard Deviation 0.66	—	—

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);

1. = mild

2. = moderate

3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=50 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=59 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment Nasal Sneezing	-0.32 units on a scale Standard Error 0.08	-0.37 units on a scale Standard Error 0.07	-0.06 units on a scale Standard Error 0.08	-0.24 units on a scale Standard Error 0.08	-0.17 units on a scale Standard Error 0.07	—	—
Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment Runny Nose	-0.43 units on a scale Standard Error 0.08	-0.47 units on a scale Standard Error 0.08	-0.12 units on a scale Standard Error 0.08	-0.36 units on a scale Standard Error 0.10	-0.23 units on a scale Standard Error 0.09	—	—
Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment Nasal Itching	-0.38 units on a scale Standard Error 0.08	-0.40 units on a scale Standard Error 0.07	-0.03 units on a scale Standard Error 0.08	-0.40 units on a scale Standard Error 0.09	-0.14 units on a scale Standard Error 0.08	—	—
Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment Nasal Congestion	-0.41 units on a scale Standard Error 0.07	-0.37 units on a scale Standard Error 0.07	-0.05 units on a scale Standard Error 0.07	-0.20 units on a scale Standard Error 0.08	-0.06 units on a scale Standard Error 0.07	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);

1. = mild

2. = moderate

3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=50 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=59 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Baseline Daily Subject-reported Individual PM Instantaneous NSS Baseline Nasal Sneezing	1.42 units on a scale Standard Deviation 0.89	1.51 units on a scale Standard Deviation 0.86	1.40 units on a scale Standard Deviation 0.93	1.30 units on a scale Standard Deviation 0.85	1.47 units on a scale Standard Deviation 0.92	—	—
Baseline Daily Subject-reported Individual PM Instantaneous NSS Baseline Runny Nose	1.80 units on a scale Standard Deviation 0.85	2.03 units on a scale Standard Deviation 0.73	1.98 units on a scale Standard Deviation 0.72	2.13 units on a scale Standard Deviation 0.75	2.01 units on a scale Standard Deviation 0.76	—	—
Baseline Daily Subject-reported Individual PM Instantaneous NSS Baseline Nasal Itching	1.60 units on a scale Standard Deviation 0.90	1.88 units on a scale Standard Deviation 0.78	1.64 units on a scale Standard Deviation 0.84	1.79 units on a scale Standard Deviation 0.87	1.84 units on a scale Standard Deviation 0.91	—	—
Baseline Daily Subject-reported Individual PM Instantaneous NSS Baseline Nasal Congestion	2.02 units on a scale Standard Deviation 0.82	2.19 units on a scale Standard Deviation 0.59	2.11 units on a scale Standard Deviation 0.68	2.16 units on a scale Standard Deviation 0.76	2.12 units on a scale Standard Deviation 0.65	—	—

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);

1. = mild

2. = moderate

3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=50 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=59 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment Nasal Sneezing	-0.33 units on a scale Standard Error 0.08	-0.37 units on a scale Standard Error 0.08	-0.07 units on a scale Standard Error 0.08	-0.24 units on a scale Standard Error 0.08	-0.22 units on a scale Standard Error 0.08	—	—
Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment Runny Nose	-0.41 units on a scale Standard Error 0.08	-0.45 units on a scale Standard Error 0.07	-0.08 units on a scale Standard Error 0.08	-0.33 units on a scale Standard Error 0.10	-0.30 units on a scale Standard Error 0.09	—	—
Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment Nasal Itching	-0.32 units on a scale Standard Error 0.08	-0.44 units on a scale Standard Error 0.07	0.02 units on a scale Standard Error 0.07	-0.35 units on a scale Standard Error 0.09	-0.25 units on a scale Standard Error 0.08	—	—
Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment Nasal Congestion	-0.34 units on a scale Standard Error 0.07	-0.39 units on a scale Standard Error 0.07	0.02 units on a scale Standard Error 0.07	-0.15 units on a scale Standard Error 0.09	-0.12 units on a scale Standard Error 0.08	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);

1. = mild

2. = moderate

3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=51 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS Baseline Nasal Sneezing	1.33 units on a scale Standard Deviation 0.83	1.47 units on a scale Standard Deviation 0.89	1.37 units on a scale Standard Deviation 0.91	1.22 units on a scale Standard Deviation 0.83	1.38 units on a scale Standard Deviation 0.95	—	—
Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS Baseline Runny Nose	1.81 units on a scale Standard Deviation 0.83	2.05 units on a scale Standard Deviation 0.67	2.00 units on a scale Standard Deviation 0.72	2.10 units on a scale Standard Deviation 0.69	1.98 units on a scale Standard Deviation 0.80	—	—
Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS Baseline Nasal Itching	1.61 units on a scale Standard Deviation 0.86	1.87 units on a scale Standard Deviation 0.75	1.70 units on a scale Standard Deviation 0.84	1.78 units on a scale Standard Deviation 0.87	1.80 units on a scale Standard Deviation 0.89	—	—
Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS Baseline Nasal Congestion	2.13 units on a scale Standard Deviation 0.72	2.23 units on a scale Standard Deviation 0.55	2.19 units on a scale Standard Deviation 0.62	2.20 units on a scale Standard Deviation 0.68	2.16 units on a scale Standard Deviation 0.63	—	—

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);

1. = mild

2. = moderate

3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=51 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 Participants Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray n=58 Participants AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment Nasal Sneezing	-0.32 units on a scale Standard Error 0.08	-0.37 units on a scale Standard Error 0.07	-0.06 units on a scale Standard Error 0.07	-0.23 units on a scale Standard Error 0.08	-0.20 units on a scale Standard Error 0.07	—	—
Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment Runny Nose	-0.42 units on a scale Standard Error 0.08	-0.47 units on a scale Standard Error 0.07	-0.10 units on a scale Standard Error 0.07	-0.35 units on a scale Standard Error 0.09	-0.27 units on a scale Standard Error 0.09	—	—
Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment Nasal Itching	-0.35 units on a scale Standard Error 0.08	-0.42 units on a scale Standard Error 0.07	-0.01 units on a scale Standard Error 0.07	-0.37 units on a scale Standard Error 0.09	-0.20 units on a scale Standard Error 0.08	—	—
Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment Nasal Congestion	-0.37 units on a scale Standard Error 0.07	-0.39 units on a scale Standard Error 0.06	-0.01 units on a scale Standard Error 0.06	-0.17 units on a scale Standard Error 0.08	-0.09 units on a scale Standard Error 0.08	—	—

SECONDARY outcome

Timeframe: Weeks 0-6

Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.

The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between each active treatment group and corresponding placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The evaluation is made separately for each dose level of Ciclesonide HFA compared to placebo. Difference is calculated as placebo - ciclesonide. Analysis of HFA data and AQ data were conducted separately.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=51 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=48 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Time to Maximal Effect Over 6 Weeks of Double-blind Treatment.	15 Number of days	29 Number of days	7 Number of days	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 1-2, 2-4

Population: Intent to Treat Population

Ratio of correct advance is defined as the (number of doses actuated/number of dose reported).

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=51 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=75 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances. Weeks 1-2 (n=49,58,75)	106.3 percentage of correct advances Standard Deviation 10.8	106.2 percentage of correct advances Standard Deviation 12.1	105.3 percentage of correct advances Standard Deviation 15.8	—	—	—	—
Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances. Weeks 2-4 (n=46,52,71)	105.6 percentage of correct advances Standard Deviation 11.8	105.9 percentage of correct advances Standard Deviation 10.5	105.8 percentage of correct advances Standard Deviation 11.7	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 1-4

Population: Intent to Treat Population

Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=46 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=52 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=71 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Number of Devices With Actuation Consistency	42 Devices	48 Devices	68 Devices	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 1-4

Population: Intent to Treat Population

Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=46 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=52 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=71 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Percentage of Devices With Actuation Consistency	91.3 percentage of devices	92.3 percentage of devices	95.8 percentage of devices	—	—	—	—

SECONDARY outcome

Timeframe: Week 6

Population: Intent to Treat Population

A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=46 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=52 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=71 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Number of Devices With Major Discrepancies	0 Devices	2 Devices	1 Devices	—	—	—	—

SECONDARY outcome

Timeframe: Week 6

Population: Intent to Treat Population

A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration.

Outcome measures

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=46 Participants Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=52 Participants Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=71 Participants HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily	Placebo Aqueous Nasal Spray AQ Nasal Spray Placebo once daily	Placebo HFA Plus 6 mg Dexamethasone Placebo HFA plus 6 mg Dexamethasone once daily	Placebo AQ Plus 6 mg Dexamethasone Placebo AQ plus 6 mg Dexamethasone once daily
Percentage of Devices With Major Discrepancies	0 percentage of devices	3.8 percentage of devices	1.4 percentage of devices	—	—	—	—

Adverse Events

Ciclesonide HFA Nasal Aerosol 320 Mcg

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Ciclesonide HFA Nasal Aerosol 160 Mcg

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

HFA Nasal Aerosol Placebo

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Ciclesonide Aqueous Nasal Spray 200 Mcg

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

AQ Nasal Spray Placebo

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ciclesonide HFA Nasal Aerosol 320 Mcg n=51 participants at risk；n=48 participants at risk Ciclesonide HFA Nasal Aerosol 320 mcg once daily	Ciclesonide HFA Nasal Aerosol 160 Mcg n=60 participants at risk；n=57 participants at risk Ciclesonide HFA Nasal Aerosol 160 mcg once daily	HFA Nasal Aerosol Placebo n=57 participants at risk；n=18 participants at risk HFA Nasal Aerosol Placebo once daily	Ciclesonide Aqueous Nasal Spray 200 Mcg n=48 participants at risk；n=47 participants at risk Ciclesonide Aqueous Nasal Spray 200 mcg once daily	AQ Nasal Spray Placebo n=58 participants at risk；n=57 participants at risk AQ Nasal Spray Placebo once daily
Ear and labyrinth disorders Vertigo	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Endocrine disorders Hyphthyroidism	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Eye disorders Conjunctivitis	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.8% 1/57 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 2 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Gastrointestinal disorders Constipation	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.8% 1/57 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Gastrointestinal disorders Dental caries	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.7% 1/60 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Gastrointestinal disorders Diarrhoea	2.0% 1/51 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.7% 1/60 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.7% 1/58 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Gastrointestinal disorders Dyspepsia	2.0% 1/51 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.7% 1/60 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/48 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Gastrointestinal disorders Nausea	2.0% 1/51 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	3.3% 2/60 • Number of events 2 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	3.5% 2/57 • Number of events 2 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	4.2% 2/48 • Number of events 2 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	3.4% 2/58 • Number of events 2 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Gastrointestinal disorders Tooth impacted	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Gastrointestinal disorders Vomiting	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	6.2% 3/48 • Number of events 3 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
General disorders Asthenia	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
General disorders Influenza like illness	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.7% 1/60 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/48 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
General disorders Instillation site discomfort	3.9% 2/51 • Number of events 2 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	3.3% 2/60 • Number of events 2 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.8% 1/57 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/48 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
General disorders Pyrexia	2.0% 1/51 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Infections and infestations Eye infection	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Infections and infestations Gastroenteritis	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	3.3% 2/60 • Number of events 2 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/48 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Infections and infestations Nasopharyngitis	7.8% 4/51 • Number of events 4 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	3.3% 2/60 • Number of events 2 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	3.5% 2/57 • Number of events 2 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	5.2% 3/58 • Number of events 3 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Infections and infestations Otitis Media	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.7% 1/60 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	4.2% 2/48 • Number of events 2 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Infections and infestations Sinusitis	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.7% 1/60 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.8% 1/57 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Infections and infestations Tooth infection	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Infections and infestations Upper respiratory tract infection	2.0% 1/51 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.7% 1/58 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Infections and infestations Urinary Tract Infection	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.7% 1/60 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/48 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.7% 1/58 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Metabolism and nutrition disorders Dehydration	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Metabolism and nutrition disorders Fluid retention	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.7% 1/60 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	4.2% 2/48 • Number of events 2 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	3.4% 2/58 • Number of events 2 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Musculoskeletal and connective tissue disorders Joint Swelling	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Musculoskeletal and connective tissue disorders Myaglia	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.7% 1/58 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Musculoskeletal and connective tissue disorders Pain in extremity	2.0% 1/51 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/48 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Nervous system disorders Dizziness	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.7% 1/60 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.8% 1/57 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.7% 1/58 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Nervous system disorders Drug withdrawal headache	2.0% 1/51 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.7% 1/58 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Nervous system disorders Headache	3.9% 2/51 • Number of events 2 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	3.3% 2/60 • Number of events 2 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	5.3% 3/57 • Number of events 3 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	8.3% 4/48 • Number of events 4 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	12.1% 7/58 • Number of events 11 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Nervous system disorders Sinus Headache	2.0% 1/51 • Number of events 2 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/48 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Nervous system disorders Somnolence	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/48 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.7% 1/58 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Psychiatric disorders Depression	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	3.3% 2/60 • Number of events 3 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/48 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Psychiatric disorders Insomnia	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.7% 1/60 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.7% 1/58 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Psychiatric disorders Panic Attack	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	4.2% 2/48 • Number of events 2 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Respiratory, thoracic and mediastinal disorders Epistaxis	23.5% 12/51 • Number of events 17 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	6.7% 4/60 • Number of events 7 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	5.3% 3/57 • Number of events 3 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	18.8% 9/48 • Number of events 16 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	5.2% 3/58 • Number of events 7 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Respiratory, thoracic and mediastinal disorders Nasal mucosal disorder	2.0% 1/51 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/48 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	3.4% 2/58 • Number of events 2 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Respiratory, thoracic and mediastinal disorders Nasal septum disorder	3.9% 2/51 • Number of events 2 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.8% 1/57 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	3.4% 2/58 • Number of events 2 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.9% 2/51 • Number of events 2 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.7% 1/60 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/57 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.7% 1/58 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
Skin and subcutaneous tissue disorders Rash	0.00% 0/51 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/60 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	1.8% 1/57 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	2.1% 1/48 • Number of events 1 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.	0.00% 0/58 Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.

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