Efficacy and Safety of Ciclesonide Nasal Spray in Participants with Seasonal Allergic Rhinitis (SAR) in Russia

Study identifier:CIC-RR-001

ClinicalTrials.gov identifier:NCT02155881

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Multi-Center, Double-Blind, Placebo-Controlled, Two-Arm, Parallel-Group, Phase III (Registration) Study to Assess the Efficacy and Safety of Ciclesonide Nasal Spray (Omnaris®) 200 mcg Once Daily in the Treatment of the Patients with Seasonal Allergic Rhinitis (SAR) in Russia

Medical condition

Seasonal Allergic Rhinitis

Phase

Phase 3

Healthy volunteers

Study drug

Ciclesonide, Ciclesonide Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Aug 2014

Primary Completion Date: 01 Oct 2014

Study Completion Date: 01 Nov 2014

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2016 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

1. Informed consent signed by a participant for participation in the study.
2. SAR male and female participants aged greater than or equal to (>=) 18 years (with a history of SAR of 2 years on longer). In the Investigator’s judgment the SAR must have been of sufficient severity to have required treatment (either continuous or intermittent) during this period, and was expected to require treatment for the duration of the study.
3. To have a demonstrated positive skin prick test or other serologic tests to at least 1 relevant seasonal allergen. A positive skin test is generally defined as a wheal 3 mm larger than the diluents control wheal for prick testing.
4. If female less than or equal to (<=) 65 years of age, must have a negative urine pregnancy test at screening. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control:
a. An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation;
b. Barrier method of contraception, for example (eg), condom and/or diaphragm with spermicide while participating in the study.

Exclusion Criteria

1. Nasal pathology, including nasal polyps, clinically relevant respiratory tract malformations, recent nasal biopsy (within 60 days), nasal trauma, nasal surgery, atrophic rhinitis, rhinitis medicamentosa (within 60 days), vasomotor rhinitis.
2. Initiation of immunotherapy during the study period or dose escalation during the study period. However, initiation of immunotherapy 90 days or more prior to the Screening Visit AND use of a stable (maintenance) dose (30 days more) may be considered for inclusion.
3. Hypersensitivity to corticosteroid or any of the excipients in the formulation of ciclesonide.
4. A history of respiratory tract infection or disorder within 2 weeks of the screening visit or had a respiratory tract infection during baseline.
5. Presence of ocular herpes simplex or cataracts or a history of glaucoma.
6. Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta (β)-agonists; intermittent use of β-agonists is acceptable.
7. Use of intranasal immunosuppressive drugs for 30 days before Baseline.
8. Female participant who is pregnant or lactating.
9. Participation in any investigational drug trial within the 30 days preceding the Screening Visit or planned participation in another investigational drug trial at any time during this trial.
10. History of a positive test for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
11. History of alcohol or drug abuse within the preceding two years.
12. Use of any prohibited concomitant medications within the prescribed (per protocol) time spent last dose period to the Screening Visit (Visit 0) and during entire treatment duration.
13. Any condition that, in the judgment of the investigator, can be clinically significant and/or affect the participant’s ability to participate in the clinical trial.
14. Exposure to systemic corticosteroids for any indication, chronic or intermittent (e.g.: contact dermatitis), during the past 2 months, or presence of an underlying condition that can reasonably be expected to require treatment with corticosteroids during the course of the study.
15. Use of topical corticosteroids in concentrations in excess of 1 percent (%) hydrocortisone for dermatological conditions during the past 1 month, or presence of an underlying condition that can reasonably be expected to require treatment with such preparations during the course of the study.

Location

Moscow, Russian Federation

Location

Saratov, Russian Federation

Location

Kazan, Russian Federation

Location

Stavropol, Russian Federation

Location

Krasnodar, Russian Federation

Arms	Assigned Interventions
Experimental: Ciclesonide 200 mcg Ciclesonide 200 mcg nasal spray, 2 actuations (sprays) per nostril (50 mcg ciclesonide/actuation), daily, for 2 weeks.	Drug: Ciclesonide Ciclesonide nasal spray 50 mcg/actuation Other Name: Omnaris®
Placebo Comparator: Placebo Ciclesonide placebo-matching nasal spray, 2 actuations (sprays) per nostril, daily, for 2 weeks.	Drug: Ciclesonide Placebo Ciclesonide placebo-matching nasal spray

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants took part in the study at 6 investigative sites in Russia from 12 August 2014 to 14 November 2014.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a historical diagnosis of seasonal allergic rhinitis (SAR) were enrolled in 1 of 2 treatment groups as follows: Ciclesonide 200 microgram (mcg) and Placebo.

Reporting Groups

	Description
Ciclesonide 200 mcg	Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
Placebo	Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.

Participant Flow: Overall Study

	Ciclesonide 200 mcg	Placebo
STARTED	40	40
COMPLETED	38	36
NOT COMPLETED	2	4
Withdrawal by Subject	0	2
Inappropriately randomized	2	2

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of double-blind study medication.

Reporting Groups

	Description
Ciclesonide 200 mcg	Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
Placebo	Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.

Baseline Measures

	Ciclesonide 200 mcg	Placebo	Total
Number of Participants [units: Participants]	40	40	80
Age Continuous [units: years] Mean ± Standard Deviation	40.98 ± 13.16	38.55 ± 11.94	39.76 ± 12.55
Gender, Male/Female [units: participants]
Female	28	17	45
Male	12	23	35
Race/Ethnicity, Customized [units: participants] White	40	40	80
Region of Enrollment [units: participants] Russia	40	40	80
Smoking Status [units: participants]
Current Smoker	2	1	3
Ex-Smoker	1	5	6
Had Never Smoked	37	34	71
Weight [units: kilogram (kg)] Mean ± Standard Deviation	70.03 ± 16.69	72.51 ± 16.81	71.27 ± 16.75
Height [units: centimeter (cm)] Mean ± Standard Deviation	166.45 ± 10.87	171.45 ± 7.45	168.95 ± 9.16

Outcome Measures

1. Primary Outcome Measure: Change from Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Nasal Symptom Scores (TNSS) [ Time Frame: Baseline and Week 1 up to Week 2 (entire treatment period) ]

Measure Type	Primary
Measure Name	Change from Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Nasal Symptom Scores (TNSS)
Measure Description	The reflective TNSS is defined as the sum of the participant-rated reflective symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.
Time Frame	Baseline and Week 1 up to Week 2 (entire treatment period)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using Last Observation Carried Forward (LOCF).

Reporting Groups

	Description
Ciclesonide 200 mcg	Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
Placebo	Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.

Measured Values

	Ciclesonide 200 mcg	Placebo
Number of Participants Analyzed [units:participants]	40	40
Change from Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Nasal Symptom Scores (TNSS) [units: scores on a scale] Mean (Standard Deviation)
Baseline	7.81 (1.83)	7.71 (1.63)
Change Over 2 Weeks	-2.85 (2.47)	-2.68 (2.11)

Statistical Analysis 1 for Change from Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Nasal Symptom Scores (TNSS)

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.9716
Mean Difference (Net)^[5]	0.02
95% Confidence Interval	( -0.98 to 1.01 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	An analysis of covariance (ANCOVA) model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

2. Secondary Outcome Measure: Change from Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Nasal Symptom Scores [ Time Frame: Baseline and Week 1 up to Week 2 (entire treatment period) ]

Measure Type	Secondary
Measure Name	Change from Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Nasal Symptom Scores
Measure Description	The instantaneous TNSS is defined as the sum of the participant-rated instantaneous symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion at the time of evaluation. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.
Time Frame	Baseline and Week 1 up to Week 2 (entire treatment period)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.

Reporting Groups

	Description
Ciclesonide 200 mcg	Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
Placebo	Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.

Measured Values

	Ciclesonide 200 mcg	Placebo
Number of Participants Analyzed [units:participants]	40	40
Change from Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Nasal Symptom Scores [units: scores on a scale] Mean (Standard Deviation)
Baseline	7.81 (1.85)	7.64 (1.90)
Change Over 2 Weeks	-2.76 (2.34)	-2.62 (2.10)

Statistical Analysis 1 for Change from Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Nasal Symptom Scores

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.8713
Mean Difference (Net)^[5]	0.08
95% Confidence Interval	( -0.87 to 1.02 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

3. Secondary Outcome Measure: Change from Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Ocular Symptom Scores (TOSS) [ Time Frame: Baseline and Week 1 up to Week 2 (entire treatment period) ]

Measure Type	Secondary
Measure Name	Change from Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Ocular Symptom Scores (TOSS)
Measure Description	The reflective TOSS is defined as the sum of the participant-rated reflective symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Reflective TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.
Time Frame	Baseline and Week 1 up to Week 2 (entire treatment period)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.

Reporting Groups

	Description
Ciclesonide 200 mcg	Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
Placebo	Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.

Measured Values

	Ciclesonide 200 mcg	Placebo
Number of Participants Analyzed [units:participants]	40	40
Change from Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Ocular Symptom Scores (TOSS) [units: scores on a scale] Mean (Standard Deviation)
Baseline	4.78 (1.20)	4.75 (1.32)
Change Over 2 Weeks	-1.68 (1.66)	-1.68 (1.66)

Statistical Analysis 1 for Change from Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Ocular Symptom Scores (TOSS)

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.7789
Mean Difference (Net)^[5]	0.10
95% Confidence Interval	( -0.61 to 0.81 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

4. Secondary Outcome Measure: Change from Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Ocular Symptom Scores [ Time Frame: Baseline and Week 1 up to Week 2 (entire treatment period) ]

Measure Type	Secondary
Measure Name	Change from Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Ocular Symptom Scores
Measure Description	The instantaneous TOSS is defined as the sum of the participant-rated instantaneous symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes at the time of evaluation. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Instantaneous TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.
Time Frame	Baseline and Week 1 up to Week 2 (entire treatment period)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.

Reporting Groups

	Description
Ciclesonide 200 mcg	Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
Placebo	Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.

Measured Values

	Ciclesonide 200 mcg	Placebo
Number of Participants Analyzed [units:participants]	40	40
Change from Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Ocular Symptom Scores [units: scores on a scale] Mean (Standard Deviation)
Baseline	4.74 (1.25)	4.69 (1.53)
Change Over 2 Weeks	-1.56 (1.67)	-1.61 (1.73)

Statistical Analysis 1 for Change from Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Ocular Symptom Scores

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.6630
Mean Difference (Net)^[5]	0.15
95% Confidence Interval	( -0.55 to 0.86 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

5. Secondary Outcome Measure: Change from Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Nasal Symptom Score [ Time Frame: Baseline and Week 1 up to Week 2 (entire treatment period) ]

Measure Type	Secondary
Measure Name	Change from Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Nasal Symptom Score
Measure Description	The reflective TNSS is defined as the sum of the participant-rated reflective symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.
Time Frame	Baseline and Week 1 up to Week 2 (entire treatment period)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.

Reporting Groups

	Description
Ciclesonide 200 mcg	Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
Placebo	Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.

Measured Values

	Ciclesonide 200 mcg	Placebo
Number of Participants Analyzed [units:participants]	40	40
Change from Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Nasal Symptom Score [units: scores on a scale] Mean (Standard Deviation)
Nasal Congestion: Baseline	2.19 (0.50)	2.22 (0.38)
Nasal Congestion: Change Over 2 Weeks	-0.70 (0.64)	-0.62 (0.63)
Runny nose: Baseline	2.04 (0.61)	2.01 (0.64)
Runny nose: Change Over 2 Weeks	-0.79 (0.71)	-0.77 (0.64)
Itchy Nose: Baseline	1.77 (0.65)	1.76 (0.43)
Itchy Nose: Change Over 2 Weeks	-0.64 (0.66)	-0.64 (0.58)
Sneezing: Baseline	1.80 (0.58)	1.73 (0.56)
Sneezing: Change Over 2 Weeks	-0.71 (0.76)	-0.64 (0.69)

Statistical Analysis 1 for Change from Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Nasal Symptom Score

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.5593
Mean Difference (Net)^[5]	-0.08
95% Confidence Interval	( -0.35 to 0.19 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Nasal congestion: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change from Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Nasal Symptom Score

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.7085
Mean Difference (Net)^[5]	0.05
95% Confidence Interval	( -0.22 to 0.33 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Runny nose: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Change from Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Nasal Symptom Score

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.7309
Mean Difference (Net)^[5]	0.05
95% Confidence Interval	( -0.22 to 0.31 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Itching: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Change from Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Nasal Symptom Score

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.9584
Mean Difference (Net)^[5]	0.01
95% Confidence Interval	( -0.29 to 0.30 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Sneezing: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

6. Secondary Outcome Measure: Change from Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Ocular Symptom Score [ Time Frame: Baseline and Week 1 up to Week 2 (entire treatment period) ]

Measure Type	Secondary
Measure Name	Change from Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Ocular Symptom Score
Measure Description	The reflective TOSS is defined as the sum of the participant-rated reflective symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Reflective TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.
Time Frame	Baseline and Week 1 up to Week 2 (entire treatment period)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.

Reporting Groups

	Description
Ciclesonide 200 mcg	Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
Placebo	Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.

Measured Values

	Ciclesonide 200 mcg	Placebo
Number of Participants Analyzed [units:participants]	40	40
Change from Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Ocular Symptom Score [units: scores on a scale] Mean (Standard Deviation)
Itching/Burning Eyes: Baseline	1.85 (0.54)	1.79 (0.53)
Itching/Burning Eyes: Change Over 2 Weeks	-0.63 (0.77)	-0.73 (0.68)
Redness: Baseline	1.57 (0.63)	1.67 (0.53)
Redness: Change Over 2 Weeks	-0.59 (0.59)	-0.52 (0.64)
Tearing/Watering Eyes: Baseline	1.37 (0.53)	1.29 (0.58)
Tearing/Watering Eyes: Change Over 2 Weeks	-0.45 (0.56)	-0.43 (0.61)

Statistical Analysis 1 for Change from Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Ocular Symptom Score

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.2266
Mean Difference (Net)^[5]	0.17
95% Confidence Interval	( -0.11 to 0.46 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Itching/Burning Eyes: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change from Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Ocular Symptom Score

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.4888
Mean Difference (Net)^[5]	-0.09
95% Confidence Interval	( -0.35 to 0.17 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Redness: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Change from Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Ocular Symptom Score

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.8316
Mean Difference (Net)^[5]	0.03
95% Confidence Interval	( -0.22 to 0.27 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Tearing/Watering Eyes: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

7. Secondary Outcome Measure: Change from Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score [ Time Frame: Baseline and Week 1 up to Week 2 (entire treatment period) ]

Measure Type	Secondary
Measure Name	Change from Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score
Measure Description	The RQLQ is a 28-item, disease-specific quality of life questionnaire that measures the functional (physical, emotional, and social) problems troublesome to adults with allergies. The RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional). All 28 questions were evaluated by the participant in an assessment diary over 2 weeks of treatment period and was rated on a 7-point severity scale ranging from 0 to 6, where 0 = least severe to 6 = extremely severe. Overall total score was calculated by taking the mean of the response of all individual 28 questions. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.
Time Frame	Baseline and Week 1 up to Week 2 (entire treatment period)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.

Reporting Groups

	Description
Ciclesonide 200 mcg	Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
Placebo	Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.

Measured Values

	Ciclesonide 200 mcg	Placebo
Number of Participants Analyzed [units:participants]	40	40
Change from Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score [units: scores on a scale] Mean (Standard Deviation)
Baseline	3.31 (0.83)	3.24 (0.85)
Change Over 2 Weeks	-1.40 (1.26)	-1.09 (1.08)

Statistical Analysis 1 for Change from Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.2968
Mean Difference (Net)^[5]	-0.28
95% Confidence Interval	( -0.80 to 0.25 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

8. Secondary Outcome Measure: Change from Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score [ Time Frame: Baseline and Week 1 up to Week 2 (entire treatment period) ]

Measure Type	Secondary
Measure Name	Change from Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score
Measure Description	The RQLQ is a 28-item, disease-specific quality of life questionnaire that measures the functional (physical, emotional, and social) problems troublesome to adults with allergies. The RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional). All 28 questions were evaluated by the participant in an assessment diary over 2 weeks of treatment period and was rated on a 7-point severity scale ranging from 0 to 6, where 0 = least severe to 6 = extremely severe. Overall domain scores were calculated by taking the mean of the response of the relevant questions. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.
Time Frame	Baseline and Week 1 up to Week 2 (entire treatment period)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.

Reporting Groups

	Description
Ciclesonide 200 mcg	Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
Placebo	Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.

Measured Values

	Ciclesonide 200 mcg	Placebo
Number of Participants Analyzed [units:participants]	40	40
Change from Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score [units: scores on a scale] Mean (Standard Deviation)
Activities: Baseline	4.07 (0.77)	4.05 (1.03)
Activities: Change Over 2 Weeks	-1.55 (1.31)	-1.24 (1.23)
Sleep: Baseline	3.22 (1.41)	3.15 (1.31)
Sleep: Change Over 2 Weeks	-1.38 (1.52)	-1.02 (1.39)
Non-Nose/Eye Symptoms: Baseline	2.74 (1.21)	2.85 (1.00)
Non-Nose/Eye Symptoms: Change Over 2 Weeks	-1.07 (1.23)	-0.90 (1.04)
Practical Problems: Baseline	4.01 (1.07)	3.50 (1.25)
Practical Problems: Change Over 2 Weeks	-1.76 (1.58)	-1.18 (1.26)
Nasal Symptoms: Baseline	4.05 (0.94)	3.90 (1.19)
Nasal Symptoms: Change Over 2 Weeks	-1.78 (1.67)	-1.44 (1.45)
Eye Symptoms: Baseline	3.01 (1.19)	2.91 (1.07)
Eye Symptoms: Change Over 2 Weeks	-1.28 (1.40)	-1.03 (1.14)
Emotional: Baseline	2.82 (1.35)	2.89 (1.18)
Emotional: Change Over 2 Weeks	-1.39 (1.45)	-1.06 (1.44)

Statistical Analysis 1 for Change from Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.3533
Mean Difference (Net)^[5]	-0.27
95% Confidence Interval	( -0.85 to 0.31 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Activities: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Change from Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.3712
Mean Difference (Net)^[5]	-0.26
95% Confidence Interval	( -0.84 to 0.32 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Sleep: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Change from Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.4098
Mean Difference (Net)^[5]	-0.20
95% Confidence Interval	( -0.69 to 0.29 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Non-nose/Eye symptoms: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Change from Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.2683
Mean Difference (Net)^[5]	-0.36
95% Confidence Interval	( -1.00 to 0.28 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Practical Problems: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Change from Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.4643
Mean Difference (Net)^[5]	-0.22
95% Confidence Interval	( -0.82 to 0.38 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Nasal Symptoms: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 6 for Change from Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.4502
Mean Difference (Net)^[5]	-0.20
95% Confidence Interval	( -0.74 to 0.33 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Eye symptoms: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 7 for Change from Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	ANCOVA
P-Value^[4]	0.1770
Mean Difference (Net)^[5]	-0.39
95% Confidence Interval	( -0.95 to 0.18 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Emotional: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Serious Adverse Events

Time Frame	Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
Additional Description	At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Reporting Groups

	Description
Ciclesonide 200 mcg	Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
Placebo	Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.

Serious Adverse Events

	Ciclesonide 200 mcg	Placebo
Total, serious adverse events
# participants affected / at risk	0/40 (0.00%)	0/40 (0.00%)

Other Adverse Events

Time Frame	Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug (Day 29).
Additional Description	At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Ciclesonide 200 mcg	Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
Placebo	Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.