Clinical Trial to Assess the Efficacy and Safety of Cicle... | NCT01010971

Label	Type	Description	Intervention Names
Ciclesonide HFA Nasal Aerosol 160 μg	Experimental	160 μg once daily	Drug: Ciclesonide HFA 160 μg
Ciclesonide HFA Nasal Aerosol 80 μg	Experimental	80 μg once daily	Drug: Ciclesonide HFA 80 μg
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Ciclesonide HFA 160 μg	Drug	Ciclesonide HFA Nasal Aerosol 160 μg once daily	Ciclesonide HFA Nasal Aerosol 160 μg

Measure	Description	Time Frame
Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over the Two-week Treatment Period.	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 = mild = moderate = 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.	Week 0-2

Measure	Description	Time Frame
Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.	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 = mild = moderate = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Give written informed consent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
Subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on screening physical examination, medical history, and clinical laboratory values (Hematology, Chemistries and Urinalysis). If any of the Hematology, Chemistries, or Urinalysis are not within the clinical laboratory's reference range, then the subject can be included only if the Investigator judges the deviations to be not clinically significant.
A history of SAR to Mountain Cedar for a minimum of two years immediately preceding the study Screening Visit. The SAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and in the Investigator's judgment (through exposure to allergen) is expected to require treatment throughout the entire study period.
A demonstrated sensitivity to Mountain Cedar known to induce SAR through a standard skin prick test administered at screening. A positive test is defined as a wheal diameter at least 5 mm larger than the control wheal (normal saline) for the skin prick test.
Subject, if female 65 years of age or younger, must have a negative serum pregnancy test. 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: An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study and will continue its use throughout the study and for thirty days following study participation; Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study; Abstinence.
Subject or parent/guardian must possess an educational level and degree of understanding of English that enables them to communicate suitably with the Investigator and study coordinator as well as accurately complete both the AR diary and RQLQ(S).

Exclusion Criteria:

Female subject who is pregnant or lactating.
History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations; recent nasal biopsy; nasal trauma; nasal ulcers or perforations; or surgery and atrophic rhinitis or rhinitis medicamentosa (all within the last 60 days prior to the Screening Visit).
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.
A known hypersensitivity to any corticosteroid or any of the excipients in the formulation of ciclesonide.
History of a respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)] within the 14 days preceding the Screening Visit .
History of alcohol or drug abuse within two years preceding the Screening Visit.
History of a positive test for HIV, hepatitis B or hepatitis C.
Plans to travel outside the study area (the known pollen area for the investigative site) for more than 24 hours during the Run-in period.
Plans to travel outside the study area (the known pollen area for the investigative site) for 2 or more consecutive days between Randomization Visit and the final Treatment Visit.
Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta-agonists and any controller drugs (eg, theophylline, leukotriene antagonists, etc.); intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists is acceptable.
Use of any disallowed concomitant medications within the prescribed (per protocol) time period prior to the Screening Visit and expected use during treatment period.
Use of antibiotic therapy for acute conditions within 14 days prior to the Screening Visit. Low doses of antibiotics taken for prophylaxis are permitted if the therapy was started prior to the Screening Visit and is expected to continue throughout the trial.
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 or more) may be considered for inclusion.
Previous participation in an intranasal ciclesonide HFA nasal aerosol study.
Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit.
Initiation of pimecrolimus cream 1% or greater or tacrolimus ointment 0.03% or greater during the study period or planned dose escalation during the study period. However, initiation of these creams/ointments 30 days or more prior to screening and use of a stable (maintenance) dose during the study period may be considered for inclusion.
Study participation by clinical investigator site employees and/or their immediate relatives.
Study participation by more than one subject from the same household at the same time.
Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial:
- impaired hepatic function including alcohol-related liver disease or cirrhosis;
- history of ocular disturbances eg, glaucoma or posterior subcapsular cataracts;
- any systemic infection;
- hematological, hepatic, renal, endocrine (except for controlled diabetes mellitus or postmenopausal symptoms or hypothyroidism);
- gastrointestinal disease;
- malignancy (excluding basal cell carcinoma);
- current neuropsychological condition with or without drug therapy.
Any condition that, in the judgement of the investigator, would preclude the subject from completing the protocol with capture of the assessments as written.

Facility	Status	City	State	ZIP	Country	Contacts
Allergy and Asthma Associates		Austin	Texas	78731	United States
Sinus Clinical Research LLC

PubMed Identifier	Type	Citation	Retractions
22370531	Result	Ratner PH, Andrews C, Martin B, Howland W, Desai SY, Huang H, Hinkle J, Bode F. A study of the efficacy and safety of ciclesonide hydrofluoroalkane nasal aerosol in patients with seasonal allergic rhinitis from mountain cedar pollen. Allergy Asthma Proc. 2012 Jan-Feb;33(1):27-35. doi: 10.2500/aap.2012.33.3490.

ID	Title	Description
FG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
FG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG00020 BG00121 BG00210 BG003

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00040.4± 14.4 BG00139.8± 14.7 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000129 BG001140 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00098± 43.6 BG00189± 39.4 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

White/Caucasian

Title	Measurements
	BG000207 BG001191 BG002

Baseline Reflective Total Nasal Symptom Score (rTNSS)

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

= mild
= moderate
= 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. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0009.33± 1.78 BG001

Baseline Instantaneous Total Nasal Symptom Score (iTNSS)

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

= mild
= moderate
= 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. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0008.77± 2.10 BG001

Baseline Baseline Reflective Ocular Symptom Score (rTOSS) in Subjects with 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

= mild
= moderate
= 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. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0007.09± 1.24 BG001

Baseline Instantaneous Total Ocular Symtom Score (iTOSS) in Subjects with 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

= mild
= moderate
= 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. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0007.07± 1.20 BG001

Baseline Reflective Nasal Symptom Score (rNSS)

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

= mild
= moderate
= 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.

Mean

Standard Deviation

unit on a scale

Title

Denominators

Categories

AM sneezing

Title	Measurements
	BG0002.04± 0.71 BG001

Baseline Instantaneous Nasal Symptom Score (iNSS)

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

= mild
= moderate
= 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.

Mean

Standard Deviation

unit on a scale

Title

Denominators

Categories

AM sneezing

Title	Measurements
	BG0001.73± 0.84 BG001

Baseline Individual Reflective Ocular Symptom Score (rOSS) in Subjects with (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

= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.)Reflective OSS 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.

Mean

Standard Deviation

unit on a scale

Title

Denominators

Categories

AM itching eyes

Title	Measurements
	BG0002.49± 0.44 BG001

Baseline Individual Instantaneous Ocular Symptom Score (iOSS) in subjects with (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

= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous OSS 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.

Mean

Standard Deviation

unit on a scale

Title

Denominators

Categories

AM itching eyes

Title	Measurements
	BG0002.47± 0.43 BG001

Baseline Rhinoconjunctivitis Quality of Life Questionnaire [RQLQ(S)] ≥3.0

RQLQ(S) in subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S) 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.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0004.30± 0.80 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over the Two-week Treatment Period.

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

= mild
= moderate
= 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.

Intent to Treat Population. Not all subjects analyzed due to missing data.

Posted

Least Squares Mean

Standard Error

Units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Units	Counts
Participants	OG000225 OG001226 OG002218

Title

Denominators

Categories

Title	Measurements
	OG000-1.74± 0.15 OG001-1.75± 0.15 OG002-0.72± 0.16

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.	ANCOVA		<0.0001	The p-value from primary outcome was adjusted at alpha=0.025.	Mean Difference (Final Values)	1.02			2-Sided	95	0.59	1.45				No	Superiority or Other

Secondary

Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.

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

= mild
= moderate
= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Intent to Treat Population. Not all subjects analyzed due to missing data.

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Secondary

Change From Baseline in Daily Subject-reported AM and PM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥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

= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Intent to Treat Population. Not all subjects analyzed due to missing data.

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Secondary

Change From Baseline in the RQLQ(S) Overall Score at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0

RQLQ(S) in impaired subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S) 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.

Intent to Treat Population. Not all subjects analyzed due to missing data.

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Secondary

Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 2-week Treatment Period.

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

= mild
= moderate
= 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.

Intent to Treat Population. Not all subjects analyzed due to missing data.

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Secondary

Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 2 Week Treatment Period.

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

= mild
= moderate
= 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.

Intent to Treat Population. Not all subjects analyzed due to missing data.

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Secondary

Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 2-week Treatment Period.

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

= mild
= moderate
= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Intent to Treat Population. Not all subjects analyzed due to missing data.

Posted

Least Squares Mean

Standard Error

units on a scale

Week0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Secondary

Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.

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

= mild
= moderate
= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Intent to Treat Population. Not all subjects analyzed due to missing data.

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Secondary

Change From Baseline in Daily Subject-reported AM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥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

= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

In subjects with baseline TOSS ≥5.0

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Secondary

Change From Baseline in Daily Subject-reported PM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥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

= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

In subjects with baseline TOSS ≥5.0

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Secondary

Change From Baseline in Daily Subject-reported AM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥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

= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

In subjects with baseline TOSS ≥5.0

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Secondary

Change From Baseline in Daily Subject-reported PM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥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

= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

In subjects with baseline TOSS ≥5.0

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Secondary

Change From Baseline in Daily Subject-reported AM and PM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥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

= mild
= moderate
= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

In subjects with baseline TOSS ≥5.0

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Secondary

Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 2-week Treatment Period

= mild
= moderate
= severe Instantaneous NSS 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.

Intent to Treat Population. Not all subjects analyzed due to missing data.

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Units

Secondary

Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 2-week Treatment Period

= mild
= moderate
= severe Instantaneous NSS 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.

Intent to Treat Population. Not all subjects analyzed due to missing data.

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Units

Secondary

Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 2-week Treatment Period

= mild
= moderate
= severe Instantaneous NSS 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.

Intent to Treat Population. Not all subjects analyzed due to missing data.

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Secondary

Change From Baseline in Daily Subject-reported Individual AM Reflective Nasal Symptom Scores (NSS) Averaged Over the 2-week Treatment Period.

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:

0 = absent (no sign/symptom evident);

= mild
= moderate
= severe Reflective NSS 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.

Intent to Treat Population. Not all subjects analyzed due to missing data.

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Secondary

Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 2-week Treatment Period.

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:

0 = absent

= mild
= moderate
= severe Reflective NSS 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.

Intent to Treat Population. Not all subjects analyzed due to missing data.

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Units	Counts

Secondary

Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 2-week Treatment Period.

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:

0 = absent

= mild
= moderate
= severe Reflective NSS 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.

Intent to Treat Population. Not all subjects analyzed due to missing data.

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Units	Counts

Secondary

Change From Baseline in Daily Subject-reported Individual AM Instantaneous OSS in Subjects With Baseline TOSS≥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

= mild
= moderate
= severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

In Subjects With Baseline TOSS≥5.0

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Secondary

Change From Baseline in Daily Subject-reported Individual PM Instantaneous OSS in Subjects With Baseline TOSS≥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

= mild
= moderate
= severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

In Subjects With Baseline TOSS≥5.0

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Secondary

Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous OSS in Subjects With Baseline TOSS≥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

= mild
= moderate
= severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

In Subjects With Baseline TOSS≥5.0

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Secondary

Change From Baseline in Daily Subject-reported Individual AM Reflective OSS in Subjects With Baseline TOSS ≥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

= mild
= moderate
= severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

In Subjects With Baseline TOSS ≥5.0

Posted

Least Squares Mean

Standard Error

participants

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Secondary

Change From Baseline in Daily Subject-reported Individual PM Reflective OSS in Subjects With Baseline TOSS ≥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

= mild
= moderate
= severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

In Subjects With Baseline TOSS ≥5.0

Posted

Least Squares Mean

Standard Error

participants

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Secondary

Change From Baseline in Daily Subject-reported Individual AM and PM Reflective OSS in Subjects With Baseline TOSS ≥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

= mild
= moderate
= severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

In Subjects With Baseline TOSS ≥5.0

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Secondary

Change From Baseline in the RQLQ(S) Domains at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0

In Impaired Subjects with Baseline RQLQ(S) Score of ≥3.0

Posted

Least Squares Mean

Standard Error

units on a scale

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
OG002	Placebo	Placebo once daily

Secondary

Time to Maximal Effect Over the 2-week of Double-blind Treatment Period.

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. The evaluation is made separately for each dose level of Ciclesonide HFA compared to placebo.

Posted

Least Squares Mean

Standard Error

Days

Week 0-2

ID	Title	Description
OG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
OG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily

Units	Counts
Participants	OG000

ID	Term
D065631	Rhinitis, Allergic
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity
D010038	Otorhinolaryngologic Diseases
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Title	Description
BG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily
BG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily
BG002	Placebo	Placebo once daily
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ciclesonide HFA Nasal Aerosol 160 μg	160 μg once daily	225	6	225
EG001	Ciclesonide HFA Nasal Aerosol 80 μg	80 μg once daily	226	3	226
EG002	Placebo	Placebo once daily	220	4	220