Trial Outcomes & Findings for Clinical Trial to Assess the Efficacy and Safety of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol for the Treatment of Seasonal Allergic Rhinitis (NCT NCT00790023)

Last Updated: 2016-04-08

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

707 participants

Primary outcome timeframe

Week 0-2

Results posted on

2016-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	80 mcg Ciclesonide 80 mcg Ciclesonide once daily	160 mcg Ciclesonide 160 mcg Ciclesonide once daily	Placebo Placebo once daily
Overall Study STARTED	237	235	235
Overall Study COMPLETED	226	225	214
Overall Study NOT COMPLETED	11	10	21

Reasons for withdrawal

Reasons for withdrawal
Measure	80 mcg Ciclesonide 80 mcg Ciclesonide once daily	160 mcg Ciclesonide 160 mcg Ciclesonide once daily	Placebo Placebo once daily
Overall Study Adverse Event	2	1	4
Overall Study Protocol Violation	2	4	2
Overall Study Withdrawal by Subject	2	0	6
Overall Study Lost to Follow-up	0	0	1
Overall Study Other	5	5	8

Baseline Characteristics

Clinical Trial to Assess the Efficacy and Safety of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol for the Treatment of Seasonal Allergic Rhinitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	80 mcg Ciclesonide n=237 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=235 Participants 160 mcg Ciclesonide once daily	Placebo n=235 Participants Placebo once daily	Total n=707 Participants Total of all reporting groups
Age, Categorical <=18 years	11 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants	31 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	220 Participants n=5 Participants	217 Participants n=7 Participants	203 Participants n=5 Participants	640 Participants n=4 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants	36 Participants n=4 Participants
Age, Continuous	41.1 years STANDARD_DEVIATION 12.7 • n=5 Participants	42.1 years STANDARD_DEVIATION 12.9 • n=7 Participants	42.2 years STANDARD_DEVIATION 13.9 • n=5 Participants	41.8 years STANDARD_DEVIATION 13.2 • n=4 Participants
Sex: Female, Male Female	159 Participants n=5 Participants	155 Participants n=7 Participants	155 Participants n=5 Participants	469 Participants n=4 Participants
Sex: Female, Male Male	78 Participants n=5 Participants	80 Participants n=7 Participants	80 Participants n=5 Participants	238 Participants n=4 Participants
Race/Ethnicity, Customized White/Caucasian	218 participants n=5 Participants	220 participants n=7 Participants	220 participants n=5 Participants	658 participants n=4 Participants
Race/Ethnicity, Customized Black/African American	13 participants n=5 Participants	8 participants n=7 Participants	14 participants n=5 Participants	35 participants n=4 Participants
Race/Ethnicity, Customized Asian	4 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	8 participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Race/Ethnicity, Customized Multiple	2 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Baseline reflective total nasal symptom score (rTNSS) AM	9.36 Units on a scale STANDARD_DEVIATION 1.76 • n=5 Participants	9.47 Units on a scale STANDARD_DEVIATION 1.68 • n=7 Participants	9.08 Units on a scale STANDARD_DEVIATION 1.85 • n=5 Participants	9.31 Units on a scale STANDARD_DEVIATION 1.77 • n=4 Participants
Baseline reflective total nasal symptom score (rTNSS) PM	9.28 Units on a scale STANDARD_DEVIATION 1.92 • n=5 Participants	9.44 Units on a scale STANDARD_DEVIATION 1.80 • n=7 Participants	9.13 Units on a scale STANDARD_DEVIATION 1.87 • n=5 Participants	9.28 Units on a scale STANDARD_DEVIATION 1.87 • n=4 Participants
Baseline reflective total nasal symptom score (rTNSS) AM and PM	9.32 Units on a scale STANDARD_DEVIATION 1.77 • n=5 Participants	9.46 Units on a scale STANDARD_DEVIATION 1.67 • n=7 Participants	9.10 Units on a scale STANDARD_DEVIATION 1.80 • n=5 Participants	9.29 Units on a scale STANDARD_DEVIATION 1.75 • n=4 Participants
Baseline instantaneous total nasal symptom score (iTNSS) AM	8.83 Units on a scale STANDARD_DEVIATION 2.03 • n=5 Participants	9.05 Units on a scale STANDARD_DEVIATION 2.02 • n=7 Participants	8.74 Units on a scale STANDARD_DEVIATION 2.05 • n=5 Participants	8.87 Units on a scale STANDARD_DEVIATION 2.03 • n=4 Participants
Baseline instantaneous total nasal symptom score (iTNSS) PM	8.53 Units on a scale STANDARD_DEVIATION 2.22 • n=5 Participants	8.82 Units on a scale STANDARD_DEVIATION 2.14 • n=7 Participants	8.48 Units on a scale STANDARD_DEVIATION 2.21 • n=5 Participants	8.61 Units on a scale STANDARD_DEVIATION 2.19 • n=4 Participants
Baseline instantaneous total nasal symptom score (iTNSS) AM and PM	8.68 Units on a scale STANDARD_DEVIATION 2.05 • n=5 Participants	8.94 Units on a scale STANDARD_DEVIATION 2.00 • n=7 Participants	8.61 Units on a scale STANDARD_DEVIATION 2.06 • n=5 Participants	8.74 Units on a scale STANDARD_DEVIATION 2.04 • n=4 Participants
Baseline reflective total ocular symptom score (rTOSS) in subjects with (rTOSS) ≥5.0 AM	6.89 Units on a scale STANDARD_DEVIATION 1.27 • n=5 Participants	6.98 Units on a scale STANDARD_DEVIATION 1.22 • n=7 Participants	6.95 Units on a scale STANDARD_DEVIATION 1.33 • n=5 Participants	6.94 Units on a scale STANDARD_DEVIATION 1.27 • n=4 Participants
Baseline reflective total ocular symptom score (rTOSS) in subjects with (rTOSS) ≥5.0 PM	6.90 Units on a scale STANDARD_DEVIATION 1.24 • n=5 Participants	7.04 Units on a scale STANDARD_DEVIATION 1.13 • n=7 Participants	6.96 Units on a scale STANDARD_DEVIATION 1.25 • n=5 Participants	6.97 Units on a scale STANDARD_DEVIATION 1.21 • n=4 Participants
Baseline reflective total ocular symptom score (rTOSS) in subjects with (rTOSS) ≥5.0 AM and PM	6.89 Units on a scale STANDARD_DEVIATION 1.19 • n=5 Participants	7.01 Units on a scale STANDARD_DEVIATION 1.11 • n=7 Participants	6.95 Units on a scale STANDARD_DEVIATION 1.23 • n=5 Participants	6.95 Units on a scale STANDARD_DEVIATION 1.18 • n=4 Participants
Baseline instantaneous total ocular symptom score (iTOSS) in subjects with (iTOSS) ≥5.0 AM	6.91 Units on a scale STANDARD_DEVIATION 1.19 • n=5 Participants	7.04 Units on a scale STANDARD_DEVIATION 1.16 • n=7 Participants	7.17 Units on a scale STANDARD_DEVIATION 1.19 • n=5 Participants	7.03 Units on a scale STANDARD_DEVIATION 1.18 • n=4 Participants
Baseline instantaneous total ocular symptom score (iTOSS) in subjects with (iTOSS) ≥5.0 PM	6.67 Units on a scale STANDARD_DEVIATION 1.29 • n=5 Participants	6.81 Units on a scale STANDARD_DEVIATION 1.24 • n=7 Participants	6.86 Units on a scale STANDARD_DEVIATION 1.35 • n=5 Participants	6.78 Units on a scale STANDARD_DEVIATION 1.29 • n=4 Participants
Baseline instantaneous total ocular symptom score (iTOSS) in subjects with (iTOSS) ≥5.0 AM and PM	6.79 Units on a scale STANDARD_DEVIATION 1.14 • n=5 Participants	6.92 Units on a scale STANDARD_DEVIATION 1.11 • n=7 Participants	7.01 Units on a scale STANDARD_DEVIATION 1.19 • n=5 Participants	6.90 Units on a scale STANDARD_DEVIATION 1.15 • n=4 Participants
Baseline reflective nasal symptom score (rNSS) AM Sneezing	2.02 Units on a scale STANDARD_DEVIATION 0.73 • n=5 Participants	2.11 Units on a scale STANDARD_DEVIATION 0.62 • n=7 Participants	2.00 Units on a scale STANDARD_DEVIATION 0.71 • n=5 Participants	2.04 Units on a scale STANDARD_DEVIATION 0.69 • n=4 Participants
Baseline reflective nasal symptom score (rNSS) AM Runny Nose	2.44 Units on a scale STANDARD_DEVIATION 0.55 • n=5 Participants	2.41 Units on a scale STANDARD_DEVIATION 0.56 • n=7 Participants	2.37 Units on a scale STANDARD_DEVIATION 0.57 • n=5 Participants	2.41 Units on a scale STANDARD_DEVIATION 0.56 • n=4 Participants
Baseline reflective nasal symptom score (rNSS) AM Nasal Itching	2.33 Units on a scale STANDARD_DEVIATION 0.59 • n=5 Participants	2.35 Units on a scale STANDARD_DEVIATION 0.54 • n=7 Participants	2.22 Units on a scale STANDARD_DEVIATION 0.61 • n=5 Participants	2.30 Units on a scale STANDARD_DEVIATION 0.58 • n=4 Participants
Baseline reflective nasal symptom score (rNSS) AM Nasal Congestion	2.57 Units on a scale STANDARD_DEVIATION 0.43 • n=5 Participants	2.60 Units on a scale STANDARD_DEVIATION 0.43 • n=7 Participants	2.48 Units on a scale STANDARD_DEVIATION 0.50 • n=5 Participants	2.55 Units on a scale STANDARD_DEVIATION 0.46 • n=4 Participants
Baseline reflective nasal symptom score (rNSS) PM Sneezing	2.08 Units on a scale STANDARD_DEVIATION 0.69 • n=5 Participants	2.17 Units on a scale STANDARD_DEVIATION 0.61 • n=7 Participants	2.11 Units on a scale STANDARD_DEVIATION 0.64 • n=5 Participants	2.12 Units on a scale STANDARD_DEVIATION 0.65 • n=4 Participants
Baseline reflective nasal symptom score (rNSS) PM Runny Nose	2.39 Units on a scale STANDARD_DEVIATION 0.59 • n=5 Participants	2.39 Units on a scale STANDARD_DEVIATION 0.58 • n=7 Participants	2.35 Units on a scale STANDARD_DEVIATION 0.58 • n=5 Participants	2.38 Units on a scale STANDARD_DEVIATION 0.58 • n=4 Participants
Baseline reflective nasal symptom score (rNSS) PM Nasal Itching	2.32 Units on a scale STANDARD_DEVIATION 0.61 • n=5 Participants	2.36 Units on a scale STANDARD_DEVIATION 0.54 • n=7 Participants	2.25 Units on a scale STANDARD_DEVIATION 0.62 • n=5 Participants	2.31 Units on a scale STANDARD_DEVIATION 0.59 • n=4 Participants
Baseline reflective nasal symptom score (rNSS) PM Nasal Congestion	2.49 Units on a scale STANDARD_DEVIATION 0.51 • n=5 Participants	2.52 Units on a scale STANDARD_DEVIATION 0.48 • n=7 Participants	2.42 Units on a scale STANDARD_DEVIATION 0.53 • n=5 Participants	2.48 Units on a scale STANDARD_DEVIATION 0.51 • n=4 Participants
Baseline reflective nasal symptom score (rNSS) AM and PM Sneezing	2.05 Units on a scale STANDARD_DEVIATION 0.69 • n=5 Participants	2.14 Units on a scale STANDARD_DEVIATION 0.59 • n=7 Participants	2.05 Units on a scale STANDARD_DEVIATION 0.65 • n=5 Participants	2.08 Units on a scale STANDARD_DEVIATION 0.65 • n=4 Participants
Baseline reflective nasal symptom score (rNSS) AM and PM Runny Nose	2.41 Units on a scale STANDARD_DEVIATION 0.55 • n=5 Participants	2.40 Units on a scale STANDARD_DEVIATION 0.55 • n=7 Participants	2.36 Units on a scale STANDARD_DEVIATION 0.56 • n=5 Participants	2.39 Units on a scale STANDARD_DEVIATION 0.55 • n=4 Participants
Baseline reflective nasal symptom score (rNSS) AM and PM Nasal Itching	2.32 Units on a scale STANDARD_DEVIATION 0.58 • n=5 Participants	2.36 Units on a scale STANDARD_DEVIATION 0.53 • n=7 Participants	2.23 Units on a scale STANDARD_DEVIATION 0.59 • n=5 Participants	2.30 Units on a scale STANDARD_DEVIATION 0.57 • n=4 Participants
Baseline reflective nasal symptom score (rNSS) AM and PM Nasal Congestion	2.53 Units on a scale STANDARD_DEVIATION 0.44 • n=5 Participants	2.56 Units on a scale STANDARD_DEVIATION 0.43 • n=7 Participants	2.45 Units on a scale STANDARD_DEVIATION 0.50 • n=5 Participants	2.51 Units on a scale STANDARD_DEVIATION 0.46 • n=4 Participants
Baseline instantaneous nasal symptom score (iNSS) AM Sneezing	1.72 Units on a scale STANDARD_DEVIATION 0.91 • n=5 Participants	1.83 Units on a scale STANDARD_DEVIATION 0.83 • n=7 Participants	1.77 Units on a scale STANDARD_DEVIATION 0.89 • n=5 Participants	1.77 Units on a scale STANDARD_DEVIATION 0.88 • n=4 Participants
Baseline instantaneous nasal symptom score (iNSS) AM Runny Nose	2.35 Units on a scale STANDARD_DEVIATION 0.59 • n=5 Participants	2.35 Units on a scale STANDARD_DEVIATION 0.64 • n=7 Participants	2.32 Units on a scale STANDARD_DEVIATION 0.61 • n=5 Participants	2.34 Units on a scale STANDARD_DEVIATION 0.61 • n=4 Participants
Baseline instantaneous nasal symptom score (iNSS) AM Nasal Itching	2.26 Units on a scale STANDARD_DEVIATION 0.62 • n=5 Participants	2.30 Units on a scale STANDARD_DEVIATION 0.61 • n=7 Participants	2.18 Units on a scale STANDARD_DEVIATION 0.61 • n=5 Participants	2.24 Units on a scale STANDARD_DEVIATION 0.62 • n=4 Participants
Baseline instantaneous nasal symptom score (iNSS) AM Nasal Congestion	2.50 Units on a scale STANDARD_DEVIATION 0.48 • n=5 Participants	2.58 Units on a scale STANDARD_DEVIATION 0.48 • n=7 Participants	2.47 Units on a scale STANDARD_DEVIATION 0.52 • n=5 Participants	2.52 Units on a scale STANDARD_DEVIATION 0.49 • n=4 Participants
Baseline instantaneous nasal symptom score (iNSS) PM Sneezing	1.77 Units on a scale STANDARD_DEVIATION 0.85 • n=5 Participants	1.92 Units on a scale STANDARD_DEVIATION 0.79 • n=7 Participants	1.81 Units on a scale STANDARD_DEVIATION 0.86 • n=5 Participants	1.83 Units on a scale STANDARD_DEVIATION 0.84 • n=4 Participants
Baseline instantaneous nasal symptom score (iNSS) PM Runny Nose	2.23 Units on a scale STANDARD_DEVIATION 0.66 • n=5 Participants	2.26 Units on a scale STANDARD_DEVIATION 0.66 • n=7 Participants	2.23 Units on a scale STANDARD_DEVIATION 0.63 • n=5 Participants	2.24 Units on a scale STANDARD_DEVIATION 0.65 • n=4 Participants
Baseline instantaneous nasal symptom score (iNSS) PM Nasal Itching	2.17 Units on a scale STANDARD_DEVIATION 0.67 • n=5 Participants	2.24 Units on a scale STANDARD_DEVIATION 0.64 • n=7 Participants	2.11 Units on a scale STANDARD_DEVIATION 0.66 • n=5 Participants	2.17 Units on a scale STANDARD_DEVIATION 0.66 • n=4 Participants
Baseline instantaneous nasal symptom score (iNSS) PM Nasal Congestion	2.36 Units on a scale STANDARD_DEVIATION 0.57 • n=5 Participants	2.39 Units on a scale STANDARD_DEVIATION 0.53 • n=7 Participants	2.33 Units on a scale STANDARD_DEVIATION 0.57 • n=5 Participants	2.36 Units on a scale STANDARD_DEVIATION 0.55 • n=4 Participants
Baseline instantaneous nasal symptom score (iNSS) AM and PM Sneezing	1.75 Units on a scale STANDARD_DEVIATION 0.86 • n=5 Participants	1.88 Units on a scale STANDARD_DEVIATION 0.78 • n=7 Participants	1.79 Units on a scale STANDARD_DEVIATION 0.85 • n=5 Participants	1.80 Units on a scale STANDARD_DEVIATION 0.83 • n=4 Participants
Baseline instantaneous nasal symptom score (iNSS) AM and PM Runny Nose	2.29 Units on a scale STANDARD_DEVIATION 0.60 • n=5 Participants	2.30 Units on a scale STANDARD_DEVIATION 0.62 • n=7 Participants	2.27 Units on a scale STANDARD_DEVIATION 0.59 • n=5 Participants	2.29 Units on a scale STANDARD_DEVIATION 0.60 • n=4 Participants
Baseline instantaneous nasal symptom score (iNSS) AM and PM Nasal Itching	2.21 Units on a scale STANDARD_DEVIATION 0.62 • n=5 Participants	2.27 Units on a scale STANDARD_DEVIATION 0.60 • n=7 Participants	2.15 Units on a scale STANDARD_DEVIATION 0.61 • n=5 Participants	2.21 Units on a scale STANDARD_DEVIATION 0.61 • n=4 Participants
Baseline instantaneous nasal symptom score (iNSS) AM and PM Nasal Congestion	2.43 Units on a scale STANDARD_DEVIATION 0.49 • n=5 Participants	2.49 Units on a scale STANDARD_DEVIATION 0.47 • n=7 Participants	2.40 Units on a scale STANDARD_DEVIATION 0.52 • n=5 Participants	2.44 Units on a scale STANDARD_DEVIATION 0.49 • n=4 Participants
Baseline individual reflective ocular symptom score (rOSS) in subjects with (rTOSS) ≥5.0 AM Itching Eyes	2.48 Units on a scale STANDARD_DEVIATION 0.42 • n=5 Participants	2.45 Units on a scale STANDARD_DEVIATION 0.50 • n=7 Participants	2.42 Units on a scale STANDARD_DEVIATION 0.49 • n=5 Participants	2.45 Units on a scale STANDARD_DEVIATION 0.47 • n=4 Participants
Baseline individual reflective ocular symptom score (rOSS) in subjects with (rTOSS) ≥5.0 AM Redness of Eyes	2.14 Units on a scale STANDARD_DEVIATION 0.59 • n=5 Participants	2.26 Units on a scale STANDARD_DEVIATION 0.53 • n=7 Participants	2.25 Units on a scale STANDARD_DEVIATION 0.55 • n=5 Participants	2.22 Units on a scale STANDARD_DEVIATION 0.56 • n=4 Participants
Baseline individual reflective ocular symptom score (rOSS) in subjects with (rTOSS) ≥5.0 AM Tearing Eyes	2.26 Units on a scale STANDARD_DEVIATION 0.52 • n=5 Participants	2.27 Units on a scale STANDARD_DEVIATION 0.48 • n=7 Participants	2.27 Units on a scale STANDARD_DEVIATION 0.53 • n=5 Participants	2.27 Units on a scale STANDARD_DEVIATION 0.51 • n=4 Participants
Baseline individual reflective ocular symptom score (rOSS) in subjects with (rTOSS) ≥5.0 PM Itching of Eyes	2.47 Units on a scale STANDARD_DEVIATION 0.40 • n=5 Participants	2.48 Units on a scale STANDARD_DEVIATION 0.43 • n=7 Participants	2.42 Units on a scale STANDARD_DEVIATION 0.45 • n=5 Participants	2.46 Units on a scale STANDARD_DEVIATION 0.43 • n=4 Participants
Baseline individual reflective ocular symptom score (rOSS) in subjects with (rTOSS) ≥5.0 PM Redness of Eyes	2.15 Units on a scale STANDARD_DEVIATION 0.57 • n=5 Participants	2.25 Units on a scale STANDARD_DEVIATION 0.50 • n=7 Participants	2.28 Units on a scale STANDARD_DEVIATION 0.55 • n=5 Participants	2.22 Units on a scale STANDARD_DEVIATION 0.54 • n=4 Participants
Baseline individual reflective ocular symptom score (rOSS) in subjects with (rTOSS) ≥5.0 PM Tearing Eyes	2.28 Units on a scale STANDARD_DEVIATION 0.50 • n=5 Participants	2.31 Units on a scale STANDARD_DEVIATION 0.46 • n=7 Participants	2.26 Units on a scale STANDARD_DEVIATION 0.50 • n=5 Participants	2.28 Units on a scale STANDARD_DEVIATION 0.48 • n=4 Participants
Baseline individual reflective ocular symptom score (rOSS) in subjects with (rTOSS) ≥5.0 AM and PM Itching Eyes	2.48 Units on a scale STANDARD_DEVIATION 0.39 • n=5 Participants	2.47 Units on a scale STANDARD_DEVIATION 0.44 • n=7 Participants	2.42 Units on a scale STANDARD_DEVIATION 0.45 • n=5 Participants	2.46 Units on a scale STANDARD_DEVIATION 0.42 • n=4 Participants
Baseline individual reflective ocular symptom score (rOSS) in subjects with (rTOSS) ≥5.0 AM and PM Redness of Eyes	2.14 Units on a scale STANDARD_DEVIATION 0.56 • n=5 Participants	2.25 Units on a scale STANDARD_DEVIATION 0.50 • n=7 Participants	2.27 Units on a scale STANDARD_DEVIATION 0.53 • n=5 Participants	2.22 Units on a scale STANDARD_DEVIATION 0.53 • n=4 Participants
Baseline individual reflective ocular symptom score (rOSS) in subjects with (rTOSS) ≥5.0 AM and PM Tearing Eyes	2.27 Units on a scale STANDARD_DEVIATION 0.48 • n=5 Participants	2.29 Units on a scale STANDARD_DEVIATION 0.44 • n=7 Participants	2.26 Units on a scale STANDARD_DEVIATION 0.49 • n=5 Participants	2.27 Units on a scale STANDARD_DEVIATION 0.47 • n=4 Participants
Baseline individual instantaneous ocular symtom score (iOSS) in subjects with (iTOSS) ≥5.0 AM Itching Eyes	2.44 Units on scale STANDARD_DEVIATION 0.44 • n=5 Participants	2.44 Units on scale STANDARD_DEVIATION 0.46 • n=7 Participants	2.48 Units on scale STANDARD_DEVIATION 0.45 • n=5 Participants	2.45 Units on scale STANDARD_DEVIATION 0.45 • n=4 Participants
Baseline individual instantaneous ocular symtom score (iOSS) in subjects with (iTOSS) ≥5.0 AM Redness of Eyes	2.22 Units on scale STANDARD_DEVIATION 0.56 • n=5 Participants	2.32 Units on scale STANDARD_DEVIATION 0.51 • n=7 Participants	2.36 Units on scale STANDARD_DEVIATION 0.52 • n=5 Participants	2.30 Units on scale STANDARD_DEVIATION 0.53 • n=4 Participants
Baseline individual instantaneous ocular symtom score (iOSS) in subjects with (iTOSS) ≥5.0 AM Tearing Eyes	2.25 Units on scale STANDARD_DEVIATION 0.50 • n=5 Participants	2.27 Units on scale STANDARD_DEVIATION 0.48 • n=7 Participants	2.33 Units on scale STANDARD_DEVIATION 0.54 • n=5 Participants	2.28 Units on scale STANDARD_DEVIATION 0.51 • n=4 Participants
Baseline individual instantaneous ocular symtom score (iOSS) in subjects with (iTOSS) ≥5.0 PM Itching Eyes	2.38 Units on scale STANDARD_DEVIATION 0.41 • n=5 Participants	2.40 Units on scale STANDARD_DEVIATION 0.47 • n=7 Participants	2.39 Units on scale STANDARD_DEVIATION 0.49 • n=5 Participants	2.39 Units on scale STANDARD_DEVIATION 0.46 • n=4 Participants
Baseline individual instantaneous ocular symtom score (iOSS) in subjects with (iTOSS) ≥5.0 PM Redness of Eyes	2.12 Units on scale STANDARD_DEVIATION 0.58 • n=5 Participants	2.22 Units on scale STANDARD_DEVIATION 0.52 • n=7 Participants	2.28 Units on scale STANDARD_DEVIATION 0.55 • n=5 Participants	2.20 Units on scale STANDARD_DEVIATION 0.55 • n=4 Participants
Baseline individual instantaneous ocular symtom score (iOSS) in subjects with (iTOSS) ≥5.0 PM Tearing Eyes	2.17 Units on scale STANDARD_DEVIATION 0.52 • n=5 Participants	2.19 Units on scale STANDARD_DEVIATION 0.49 • n=7 Participants	2.19 Units on scale STANDARD_DEVIATION 0.56 • n=5 Participants	2.18 Units on scale STANDARD_DEVIATION 0.52 • n=4 Participants
Baseline individual instantaneous ocular symtom score (iOSS) in subjects with (iTOSS) ≥5.0 AM and PM Itching Eyes	2.41 Units on scale STANDARD_DEVIATION 0.38 • n=5 Participants	2.42 Units on scale STANDARD_DEVIATION 0.43 • n=7 Participants	2.43 Units on scale STANDARD_DEVIATION 0.45 • n=5 Participants	2.42 Units on scale STANDARD_DEVIATION 0.42 • n=4 Participants
Baseline individual instantaneous ocular symtom score (iOSS) in subjects with (iTOSS) ≥5.0 AM and PM Redness of Eyes	2.17 Units on scale STANDARD_DEVIATION 0.54 • n=5 Participants	2.27 Units on scale STANDARD_DEVIATION 0.49 • n=7 Participants	2.32 Units on scale STANDARD_DEVIATION 0.51 • n=5 Participants	2.25 Units on scale STANDARD_DEVIATION 0.51 • n=4 Participants
Baseline individual instantaneous ocular symtom score (iOSS) in subjects with (iTOSS) ≥5.0 AM and PM Tearing Eyes	2.21 Units on scale STANDARD_DEVIATION 0.47 • n=5 Participants	2.23 Units on scale STANDARD_DEVIATION 0.45 • n=7 Participants	2.26 Units on scale STANDARD_DEVIATION 0.51 • n=5 Participants	2.23 Units on scale STANDARD_DEVIATION 0.47 • n=4 Participants
Baseline Instantaneous Total Ocular Symptoms Scores (iTOSS)] for Onset of Nasal Improvement	6.85 Hours STANDARD_DEVIATION 1.72 • n=5 Participants	7.02 Hours STANDARD_DEVIATION 1.54 • n=7 Participants	6.98 Hours STANDARD_DEVIATION 1.60 • n=5 Participants	6.95 Hours STANDARD_DEVIATION 1.62 • n=4 Participants
Baseline Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in subject with RQLQ(S) score ≥3.	4.52 units on a scale STANDARD_DEVIATION 0.77 • n=5 Participants	4.49 units on a scale STANDARD_DEVIATION 0.78 • n=7 Participants	4.43 units on a scale STANDARD_DEVIATION 0.83 • n=5 Participants	4.48 units on a scale STANDARD_DEVIATION 0.79 • n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	109 Participants n=5 Participants	102 Participants n=7 Participants	109 Participants n=5 Participants	320 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	128 Participants n=5 Participants	133 Participants n=7 Participants	126 Participants n=5 Participants	387 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 0-2

Population: Intent to treat population.

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=237 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=234 Participants 160 mcg Ciclesonide once daily	Placebo n=234 Participants Placebo once daily
Change From Baseline in Daily Subject-reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Averaged Over the Two-week Treatment Period.	-1.45 units on a scale Standard Error 0.14	-1.59 units on a scale Standard Error 0.14	-0.51 units on a scale Standard Error 0.14

SECONDARY outcome

Timeframe: Week 0-2

Population: Intent to treat population

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

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=237 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=234 Participants 160 mcg Ciclesonide once daily	Placebo n=234 Participants Placebo once daily
Change From Baseline in Daily Subject-reported AM and PM iTNSS Averaged Over the Two-week Treatment Period.	-1.34 units on a scale Standard Error 0.13	-1.47 units on a scale Standard Error 0.13	-0.47 units on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: Week 0-2

Population: Intent to treat population. In participants with a baseline rTOSS \>= 5.0

TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=164 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=160 Participants 160 mcg Ciclesonide once daily	Placebo n=147 Participants Placebo once daily
Change From Baseline in Daily Subject-reported AM and PM rTOSS Averaged Over the Two-week Treatment Period in Participants With a Baseline rTOSS >= 5.0	-1.06 units on a scale Standard Error 0.12	-1.05 units on a scale Standard Error 0.12	-0.44 units on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: Week 0-2

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=237 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=234 Participants 160 mcg Ciclesonide once daily	Placebo n=234 Participants Placebo once daily
Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the Two Week Treatment Period	-1.45 Units on a scale Standard Error 0.14	-1.56 Units on a scale Standard Error 0.14	-0.53 Units on a scale Standard Error 0.14

SECONDARY outcome

Timeframe: Week 0-2

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=237 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=234 Participants 160 mcg Ciclesonide once daily	Placebo n=234 Participants Placebo once daily
Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the Two Week Treatment Period	-1.46 Units on a scale Standard Error 0.14	-1.60 Units on a scale Standard Error 0.14	-0.51 Units on a scale Standard Error 0.14

SECONDARY outcome

Timeframe: Week 0-2

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

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=237 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=234 Participants 160 mcg Ciclesonide once daily	Placebo n=234 Participants Placebo once daily
Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the Two Week Treatment Period	-1.32 Units on a scale Standard Error 0.13	-1.37 Units on a scale Standard Error 0.14	-0.46 Units on a scale Standard Error 0.14

SECONDARY outcome

Timeframe: Week 0-2

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

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=237 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=234 Participants 160 mcg Ciclesonide once daily	Placebo n=234 Participants Placebo once daily
Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the Two Week Treatment Period	-1.36 Units on a scale Standard Error 0.14	-1.55 Units on a scale Standard Error 0.14	-0.49 Units on a scale Standard Error 0.14

SECONDARY outcome

Timeframe: Week 0-2

Population: In Subjects With Baseline rTOSS ≥5.0

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=164 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=160 Participants 160 mcg Ciclesonide once daily	Placebo n=147 Participants Placebo once daily
Change From Baseline in Daily Subject-reported AM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0	-1.03 Units on a scale Standard Error 0.12	-0.98 Units on a scale Standard Error 0.12	-0.41 Units on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: Week 0-2

Population: In Subjects With Baseline rTOSS ≥5.0

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=164 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=160 Participants 160 mcg Ciclesonide once daily	Placebo n=147 Participants Placebo once daily
Change From Baseline in Daily Subject-reported PM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0	-1.09 Units on a scale Standard Error 0.12	-1.11 Units on a scale Standard Error 0.12	-0.47 Units on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: Week 0-2

Population: In Subjects With Baseline iTOSS ≥5.0

TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=149 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=150 Participants 160 mcg Ciclesonide once daily	Placebo n=133 Participants Placebo once daily
Change From Baseline in Daily Subject-reported AM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0	-0.96 Units on a scale Standard Error 0.13	-0.99 Units on a scale Standard Error 0.13	-0.42 Units on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: Week 0-2

Population: In Subjects With Baseline iTOSS ≥5.0

TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=149 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=150 Participants 160 mcg Ciclesonide once daily	Placebo n=133 Participants Placebo once daily
Change From Baseline in Daily Subject-reported PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0	-1.06 Units on a scale Standard Error 0.13	-1.16 Units on a scale Standard Error 0.13	-0.36 Units on a scale Standard Error 0.14

SECONDARY outcome

Timeframe: Week 0-2

Population: In Subjects With Baseline iTOSS ≥5.0

TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=149 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=150 Participants 160 mcg Ciclesonide once daily	Placebo n=133 Participants Placebo once daily
Change From Baseline in Daily Subject Reported AM and PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0	-1.00 Units on a scale Standard Error 0.12	-1.07 Units on a scale Standard Error 0.12	-0.40 Units on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: Week 0-2

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=237 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=234 Participants 160 mcg Ciclesonide once daily	Placebo n=234 Participants Placebo once daily
Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period Sneezing	-0.39 Units on a scale Standard Error 0.04	-0.43 Units on a scale Standard Error 0.04	-0.12 Units on a scale Standard Error 0.04
Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period Runny Nose	-0.32 Units on a scale Standard Error 0.04	-0.35 Units on a scale Standard Error 0.04	-0.13 Units on a scale Standard Error 0.04
Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period Nasal Itching	-0.38 Units on a scale Standard Error 0.04	-0.43 Units on a scale Standard Error 0.04	-0.17 Units on a scale Standard Error 0.04
Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period Nasal Congestion	-0.35 Units on a scale Standard Error 0.03	-0.36 Units on a scale Standard Error 0.03	-0.12 Units on a scale Standard Error 0.03

SECONDARY outcome

Timeframe: Week 0-2

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=237 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=234 Participants 160 mcg Ciclesonide once daily	Placebo n=234 Participants Placebo once daily
Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period Runny Nose	-0.32 Units on a scale Standard Error 0.04	-0.37 Units on a scale Standard Error 0.04	-0.10 Units on a scale Standard Error 0.04
Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period Nasal Itching	-0.38 Units on a scale Standard Error 0.04	-0.44 Units on a scale Standard Error 0.04	-0.17 Units on a scale Standard Error 0.04
Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period Sneezing	-0.41 Units on a scale Standard Error 0.04	-0.46 Units on a scale Standard Error 0.04	-0.13 Units on a scale Standard Error 0.04
Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period Nasal Congestion	-0.35 Units on a scale Standard Error 0.04	-0.35 Units on a scale Standard Error 0.04	-0.11 Units on a scale Standard Error 0.04

SECONDARY outcome

Timeframe: Week 0-2

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=237 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=234 Participants 160 mcg Ciclesonide once daily	Placebo n=234 Participants Placebo once daily
Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period Nasal Congestion	-0.35 Units on a scale Standard Error 0.03	-0.36 Units on a scale Standard Error 0.03	-0.11 Units on a scale Standard Error 0.03
Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period Sneezing	-0.40 Units on a scale Standard Error 0.04	-0.44 Units on a scale Standard Error 0.04	-0.12 Units on a scale Standard Error 0.04
Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period Runny Nose	-0.32 Units on a scale Standard Error 0.04	-0.36 Units on a scale Standard Error 0.04	-0.11 Units on a scale Standard Error 0.04
Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period Nasal Itching	-0.38 Units on a scale Standard Error 0.04	-0.43 Units on a scale Standard Error 0.04	-0.16 Units on a scale Standard Error 0.04

SECONDARY outcome

Timeframe: Week 0-2

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=237 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=234 Participants 160 mcg Ciclesonide once daily	Placebo n=234 Participants Placebo once daily
Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period Nasal Congestion	-0.31 Units on a scale Standard Error 0.03	-0.33 Units on a scale Standard Error 0.03	-0.11 Units on a scale Standard Error 0.03
Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period Sneezing	-0.33 Units on a scale Standard Error 0.04	-0.33 Units on a scale Standard Error 0.04	-0.10 Units on a scale Standard Error 0.04
Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period Runny Nose	-0.30 Units on a scale Standard Error 0.04	-0.29 Units on a scale Standard Error 0.04	-0.09 Units on a scale Standard Error 0.04
Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period Nasal Itching	-0.38 Units on a scale Standard Error 0.04	-0.42 Units on a scale Standard Error 0.04	-0.16 Units on a scale Standard Error 0.04

SECONDARY outcome

Timeframe: Week 0-2

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=237 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=234 Participants 160 mcg Ciclesonide once daily	Placebo n=234 Participants Placebo once daily
Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period Sneezing	-0.37 Units on a scale Standard Error 0.04	-0.43 Units on a scale Standard Error 0.04	-0.14 Units on a scale Standard Error 0.04
Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period Runny Nose	-0.30 Units on a scale Standard Error 0.04	-0.35 Units on a scale Standard Error 0.04	-0.11 Units on a scale Standard Error 0.04
Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period Nasal Itching	-0.35 Units on a scale Standard Error 0.04	-0.44 Units on a scale Standard Error 0.04	-0.14 Units on a scale Standard Error 0.04
Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period Nasal Congestion	-0.33 Units on a scale Standard Error 0.04	-0.33 Units on a scale Standard Error 0.04	-0.09 Units on a scale Standard Error 0.04

SECONDARY outcome

Timeframe: Week 0-2

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Instantaneous NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=237 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=234 Participants 160 mcg Ciclesonide once daily	Placebo n=234 Participants Placebo once daily
Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period Runny Nose	-0.30 Units on a scale Standard Error 0.04	-0.33 Units on a scale Standard Error 0.04	-0.10 Units on a scale Standard Error 0.04
Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period Sneezing	-0.35 Units on a scale Standard Error 0.04	-0.38 Units on a scale Standard Error 0.04	-0.12 Units on a scale Standard Error 0.04
Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period Nasal Itching	-0.37 Units on a scale Standard Error 0.04	-0.43 Units on a scale Standard Error 0.04	-0.15 Units on a scale Standard Error 0.04
Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period Nasal Congestion	-0.32 Units on a scale Standard Error 0.03	-0.33 Units on a scale Standard Error 0.03	-0.33 Units on a scale Standard Error 0.03

SECONDARY outcome

Timeframe: Week 0-2

Population: In Subjects With Baseline rTOSS ≥5.0

OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=164 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=160 Participants 160 mcg Ciclesonide once daily	Placebo n=147 Participants Placebo once daily
Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 Redness of Eyes	-0.32 Units on a scale Standard Error 0.04	-0.31 Units on a scale Standard Error 0.04	-0.12 Units on a scale Standard Error 0.05
Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 Itching Eyes	-0.36 Units on a scale Standard Error 0.04	-0.33 Units on a scale Standard Error 0.04	-0.14 Units on a scale Standard Error 0.04
Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 Tearing Eyes	-0.36 Units on a scale Standard Error 0.04	-0.35 Units on a scale Standard Error 0.04	-0.16 Units on a scale Standard Error 0.04

SECONDARY outcome

Timeframe: Week 0-2

Population: In Subjects With Baseline rTOSS ≥5.0

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=164 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=160 Participants 160 mcg Ciclesonide once daily	Placebo n=147 Participants Placebo once daily
Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 Itching Eyes	-0.34 Units on a scale Standard Error 0.04	-0.35 Units on a scale Standard Error 0.04	-0.14 Units on a scale Standard Error 0.04
Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 Redness of Eyes	-0.35 Units on a scale Standard Error 0.05	-0.34 Units on a scale Standard Error 0.05	-0.16 Units on a scale Standard Error 0.05
Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 Tearing Eyes	-0.39 Units on a scale Standard Error 0.04	-0.42 Units on a scale Standard Error 0.04	-0.16 Units on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Week 0-2

Population: In Subjects With Baseline rTOSS ≥5.0

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=164 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=160 Participants 160 mcg Ciclesonide once daily	Placebo n=147 Participants Placebo once daily
Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 Itching Eyes	-0.35 Units on a scale Standard Error 0.04	-0.34 Units on a scale Standard Error 0.04	-0.14 Units on a scale Standard Error 0.04
Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 Redness of Eyes	-0.33 Units on a scale Standard Error 0.04	-0.32 Units on a scale Standard Error 0.04	-0.14 Units on a scale Standard Error 0.05
Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 Tearing Eyes	-0.38 Units on a scale Standard Error 0.04	-0.38 Units on a scale Standard Error 0.04	-0.16 Units on a scale Standard Error 0.04

SECONDARY outcome

Timeframe: Week 0-2

Population: In Subjects With Baseline iTOSS ≥5.0

OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=149 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=150 Participants 160 mcg Ciclesonide once daily	Placebo n=133 Participants Placebo once daily
Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 Itching Eyes	-0.33 Units on a scale Standard Error 0.04	-0.32 Units on a scale Standard Error 0.04	-0.17 Units on a scale Standard Error 0.05
Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 Tearing Eyes	-0.31 Units on a scale Standard Error 0.05	-0.35 Units on a scale Standard Error 0.05	-0.13 Units on a scale Standard Error 0.05
Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 Redness of Eyes	-0.33 Units on a scale Standard Error 0.05	-0.32 Units on a scale Standard Error 0.05	-0.10 Units on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Week 0-2

Population: In Subjects With Baseline iTOSS ≥5.0

OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=149 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=150 Participants 160 mcg Ciclesonide once daily	Placebo n=133 Participants Placebo once daily
Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 Itching Eyes	-0.34 Units on a scale Standard Error 0.04	-0.36 Units on a scale Standard Error 0.04	-0.13 Units on a scale Standard Error 0.05
Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 Redness of Eyes	-0.36 Units on a scale Standard Error 0.05	-0.38 Units on a scale Standard Error 0.05	-0.13 Units on a scale Standard Error 0.05
Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 Tearing Eyes	-0.36 Units on a scale Standard Error 0.05	-0.42 Units on a scale Standard Error 0.05	-0.10 Units on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Week 0-2

Population: In Subjects With Baseline iTOSS ≥5.0

OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=149 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=150 Participants 160 mcg Ciclesonide once daily	Placebo n=133 Participants Placebo once daily
Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 Itching Eyes	-0.34 Units on a scale Standard Error 0.04	-0.34 Units on a scale Standard Error 0.04	-0.15 Units on a scale Standard Error 0.04
Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 Redness of Eyes	-0.34 Units on a scale Standard Error 0.04	-0.35 Units on a scale Standard Error 0.04	-0.12 Units on a scale Standard Error 0.05
Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 Tearing Eyes	-0.33 Units on a scale Standard Error 0.04	-0.38 Units on a scale Standard Error 0.04	-0.12 Units on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Week 0-2

Population: In participants with a Baseline overall score \>= 3.0

The RQLQ(S) in impaired subjects (baseline RQLQ\[S\] score ≥3.0) at baseline and end of week 2. It consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=186 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=181 Participants 160 mcg Ciclesonide once daily	Placebo n=180 Participants Placebo once daily
Change From Baseline in Overall Score of the Rhinoconjunctivitis Quality of Life Questionnaire With Standard Activities (RQLQ(S)) in Participants With a Baseline Overall Score >= 3.0	-1.05 units on a scale Standard Error 0.10	-1.07 units on a scale Standard Error 0.10	-0.42 units on a scale Standard Error 0.10

SECONDARY outcome

Timeframe: Baseline and up to 36 hours

Population: Intent to Treat Population. Some participants excluded for missing data.

Onset of nasal improvement was defined as the first assessment at which iTNSS for active treatment demonstrated an improvement over placebo from baseline. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and 12 reflecting more severe symptoms). Instaneous measures these symptoms over the previous 10 minute time interval.

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=237 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=235 Participants 160 mcg Ciclesonide once daily	Placebo n=235 Participants Placebo once daily
Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) Day 1, 6 Hours Postdose (n=235, 234, 231)	-1.19 Units on a scale Standard Error 0.16	-1.36 Units on a scale Standard Error 0.16	-1.19 Units on a scale Standard Error 0.16
Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) Day 2, Predose (n=237,234,233)	-0.57 Units on a scale Standard Error 0.15	-0.81 Units on a scale Standard Error 0.15	-0.45 Units on a scale Standard Error 0.15
Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) Day 2, 6 Hours Postdose (n=237,233,231)	-1.56 Units on a scale Standard Error 0.17	-1.59 Units on a scale Standard Error 0.17	-1.16 Units on a scale Standard Error 0.17
Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) Day 1, 4 Hours Postdose (n=237, 233, 233)	-0.77 Units on a scale Standard Error 0.15	-0.79 Units on a scale Standard Error 0.15	-0.84 Units on a scale Standard Error 0.15
Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) Day 1, 8 Hours Postdose (n=236, 233, 233)	-1.31 Units on a scale Standard Error 0.16	-1.35 Units on a scale Standard Error 0.16	-1.14 Units on a scale Standard Error 0.16
Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) Day 1, 10 Hours Postdose (n=237,232,231)	-1.34 Units on a scale Standard Error 0.16	-1.19 Units on a scale Standard Error 0.16	-0.90 Units on a scale Standard Error 0.16
Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) Day 1, 12 Hours Postdose (n=236, 233, 233)	-1.14 Units on a scale Standard Error 0.16	-1.15 Units on a scale Standard Error 0.16	-0.87 Units on a scale Standard Error 0.16
Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) Day 2, 12 Hours Postdose (n=235,233,232)	-1.35 Units on a scale Standard Error 0.16	-1.59 Units on a scale Standard Error 0.17	-0.77 Units on a scale Standard Error 0.17

SECONDARY outcome

Timeframe: Baseline and up to 48 hours

Population: In Subjects With Baseline iTOSS ≥5.0

Onset of improvement iTOSS was defined as the first assessment at which iTOSSS for active treatment demonstrated an improvement over placebo from baseline. TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval.

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=149 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=150 Participants 160 mcg Ciclesonide once daily	Placebo n=134 Participants Placebo once daily
Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 Day 1, 4 Hours Postdose (n=149, 150, 132)	-0.69 Units on a scale Standard Error 0.14	-0.57 Units on a scale Standard Error 0.14	-0.53 Units on a scale Standard Error 0.15
Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 Day 1, 6 Hours Postdose (n=149, 150, 132)	-0.93 Units on a scale Standard Error 0.16	-0.83 Units on a scale Standard Error 0.16	-0.75 Units on a scale Standard Error 0.17
Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 Day 1, 8 Hours Postdose (n=148, 150, 132)	-0.97 Units on a scale Standard Error 0.15	-0.97 Units on a scale Standard Error 0.15	-0.72 Units on a scale Standard Error 0.16
Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 Day 1, 10 Hours Postdose (n=149, 150, 132)	-1.02 Units on a scale Standard Error 0.16	-0.79 Units on a scale Standard Error 0.15	-0.69 Units on a scale Standard Error 0.17
Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 Day 1, 12 Hours Postdose (n=149, 148, 132)	-0.80 Units on a scale Standard Error 0.15	-0.83 Units on a scale Standard Error 0.15	-0.49 Units on a scale Standard Error 0.16
Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 Day 2, 6 Hours Postdose (n=149, 150, 131)	-1.11 Units on a scale Standard Error 0.16	-1.15 Units on a scale Standard Error 0.16	-0.71 Units on a scale Standard Error 0.17
Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 Day 2, Predose (n=149, 149, 132)	-0.29 Units on a scale Standard Error 0.15	-0.37 Units on a scale Standard Error 0.15	-0.09 Units on a scale Standard Error 0.16
Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 Day 2, 12 Hours Postdose (n=149, 149, 132)	-1.09 Units on a scale Standard Error 0.16	-1.26 Units on a scale Standard Error 0.16	-0.47 Units on a scale Standard Error 0.17

SECONDARY outcome

Timeframe: Week 0-2

Population: Intent to Treat Population

The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between Ciclesonide HFA and placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day.

Outcome measures

Outcome measures
Measure	80 mcg Ciclesonide n=237 Participants 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=235 Participants 160 mcg Ciclesonide once daily	Placebo Placebo once daily
Time to Maximal Effect as Measured by Change From Baseline in the Average AM and PM Reflective Total Nasal Symptoms Scores (rTNSS)	13 days Standard Error 0.20	8 days Standard Error 0.17	—

Adverse Events

80 mcg Ciclesonide

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

160 mcg Ciclesonide

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	80 mcg Ciclesonide n=237 participants at risk 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=235 participants at risk 160 mcg Ciclesonide once daily	Placebo n=235 participants at risk Placebo once daily
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/237 A treatment emergent adverse event is defined as an event with onset data occuring on or after the date of first dose of study medication. A subject with multiple events per system organ class or per preferred term was counted only once per system organ class.	0.43% 1/235 • Number of events 1 A treatment emergent adverse event is defined as an event with onset data occuring on or after the date of first dose of study medication. A subject with multiple events per system organ class or per preferred term was counted only once per system organ class.	0.00% 0/235 A treatment emergent adverse event is defined as an event with onset data occuring on or after the date of first dose of study medication. A subject with multiple events per system organ class or per preferred term was counted only once per system organ class.

Other adverse events

Other adverse events
Measure	80 mcg Ciclesonide n=237 participants at risk 80 mcg Ciclesonide once daily	160 mcg Ciclesonide n=235 participants at risk 160 mcg Ciclesonide once daily	Placebo n=235 participants at risk Placebo once daily
Respiratory, thoracic and mediastinal disorders Epistaxis	3.4% 8/237 • Number of events 9 A treatment emergent adverse event is defined as an event with onset data occuring on or after the date of first dose of study medication. A subject with multiple events per system organ class or per preferred term was counted only once per system organ class.	2.1% 5/235 • Number of events 7 A treatment emergent adverse event is defined as an event with onset data occuring on or after the date of first dose of study medication. A subject with multiple events per system organ class or per preferred term was counted only once per system organ class.	4.3% 10/235 • Number of events 11 A treatment emergent adverse event is defined as an event with onset data occuring on or after the date of first dose of study medication. A subject with multiple events per system organ class or per preferred term was counted only once per system organ class.
Respiratory, thoracic and mediastinal disorders Nasal discomort	2.1% 5/237 • Number of events 5 A treatment emergent adverse event is defined as an event with onset data occuring on or after the date of first dose of study medication. A subject with multiple events per system organ class or per preferred term was counted only once per system organ class.	2.1% 5/235 • Number of events 5 A treatment emergent adverse event is defined as an event with onset data occuring on or after the date of first dose of study medication. A subject with multiple events per system organ class or per preferred term was counted only once per system organ class.	3.0% 7/235 • Number of events 7 A treatment emergent adverse event is defined as an event with onset data occuring on or after the date of first dose of study medication. A subject with multiple events per system organ class or per preferred term was counted only once per system organ class.
Respiratory, thoracic and mediastinal disorders Nasal septum disorder	2.1% 5/237 • Number of events 5 A treatment emergent adverse event is defined as an event with onset data occuring on or after the date of first dose of study medication. A subject with multiple events per system organ class or per preferred term was counted only once per system organ class.	0.43% 1/235 • Number of events 1 A treatment emergent adverse event is defined as an event with onset data occuring on or after the date of first dose of study medication. A subject with multiple events per system organ class or per preferred term was counted only once per system organ class.	1.3% 3/235 • Number of events 3 A treatment emergent adverse event is defined as an event with onset data occuring on or after the date of first dose of study medication. A subject with multiple events per system organ class or per preferred term was counted only once per system organ class.
General disorders Instillation site irritation	2.1% 5/237 • Number of events 5 A treatment emergent adverse event is defined as an event with onset data occuring on or after the date of first dose of study medication. A subject with multiple events per system organ class or per preferred term was counted only once per system organ class.	1.3% 3/235 • Number of events 3 A treatment emergent adverse event is defined as an event with onset data occuring on or after the date of first dose of study medication. A subject with multiple events per system organ class or per preferred term was counted only once per system organ class.	0.85% 2/235 • Number of events 2 A treatment emergent adverse event is defined as an event with onset data occuring on or after the date of first dose of study medication. A subject with multiple events per system organ class or per preferred term was counted only once per system organ class.

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