A 6 Month Safety and Efficacy Study of Once Daily Cicleso... | NCT00953147

NCT00953147

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ciclesonide HFA 80 mcg once daily	Experimental	Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).	Drug: Ciclesonide HFA 80 mcg
Ciclesonide HFA 160 mcg once daily	Experimental	Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).	Drug: Ciclesonide HFA 160 mcg
Placebo once daily	Placebo Comparator	The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ciclesonide HFA 80 mcg	Drug	Ciclesonide HFA Nasal Aerosol 80 mcg once daily for 6 months in the treatment of Perennial Allergic Rhinitis (PAR) in subjects 12 years and older.	Ciclesonide HFA 80 mcg once daily

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS (rTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment	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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.	Weeks 0-6

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS (iTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment	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 six 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 and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
Subject must be in general good health based on screening physical examination, medical history, and clinical laboratory values.
If any of the Screening visit 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 PAR to a relevant perennial allergen (house dust mites, cockroach, molds, animal dander) for a minimum of two years immediately preceding the study Screening visit. The PAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and require treatment throughout the entire study period.
A demonstrated sensitivity at the Screening visit to at least one allergen known to induce PAR (house dust mite, animal dander, cockroach, and molds) using a standard skin-prick test. The subject's positive allergen test must be consistent with the medical history of PAR and must be present in the subject's environment throughout the study.
Based upon subject's medical history, in the Investigator's judgment, the subject is unlikely to have a seasonal exacerbation during the first 6 weeks of double-blind treatment.
Subject, if female ≤65 years of age, must have a negative serum 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.

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; or nasal ulcers or perforations. Surgery and atrophic rhinitis or rhinitis medicamentosa are not permitted within the last 60 days prior to the Screening visit.
Subject is, in the investigator's judgement, having a seasonal exacerbation at the time of screening.
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, influenza, severe acute respiratory syndrome (SARS)] within the 14 days preceding the Screening visit.
History of alcohol or drug abuse within 2 years preceding the Screening visit .
History of a positive test for HIV, hepatitis B or hepatitis C.
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 short acting beta-agonists for exercise-induced bronchospasm will be allowed.
Expected use of any disallowed concomitant medications during the treatment period.
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.
Study participation by clinical investigator site employees and/or their immediate relatives who reside in the same household.
Study participation by more than one subject from the same household.
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 judgment of the investigator, would preclude the subject from completing the protocol with capture of the assessments as written.

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Asthma and Allergy Specialists Medical Group		Huntington Beach	California	92647	United States
California Allergy and Asthma Medical Group

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22370530	Result	Mohar D, Berger WE, Laforce C, Raphael G, Desai SY, Huang H, Hinkle J. Efficacy and tolerability study of ciclesonide nasal aerosol in patients with perennial allergic rhinitis. Allergy Asthma Proc. 2012 Jan-Feb;33(1):19-26. doi: 10.2500/aap.2012.33.3522.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Ciclesonide HFA 80 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
FG001	Ciclesonide HFA 160 Mcg Once Daily

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Ciclesonide HFA 80 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
BG001	Ciclesonide HFA 160 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
BG002	Placebo Once Daily	The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
BG003	Total	Total of all reporting groups

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	BG00027 BG00144 BG00217 BG003

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00037.5± 14.3 BG00136.5± 13.2 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000196 BG001310 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00062 BG00194 BG002

Race/Ethnicity

Number

participants

Title

Denominators

Categories

White/Caucasian

Title	Measurements
	BG000249 BG001420 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
	BG0008.51± 1.89 BG001

Baseline Instanteous 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, 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. 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
	BG0007.93± 2.27 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

units on a scale

Title

Denominators

Categories

AM Sneezing

Title	Measurements
	BG0001.73± 0.73 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

units on a scale

Title

Denominators

Categories

AM Sneezing

Title	Measurements
	BG0001.38± 0.91 BG001

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

Baseline Rhinoconjunctivitis Quality of Life Questionnaire [RQLQ(S)] Score in Subjects with baseline RQLQ(S) ≥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
	BG0004.16± 0.77 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 (rTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment

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 six 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

Weeks 0-6

ID	Title	Description
OG000	Ciclesonide HFA 80 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
OG001	Ciclesonide HFA 160 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
OG002	Placebo Once Daily	The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.

Units	Counts
Participants	OG000298 OG001504 OG002305

Title

Denominators

Categories

Title	Measurements
	OG000-1.97± 0.13 OG001-1.82± 0.10 OG002-1.28± 0.13

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 iTNSS 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)	0.69			2-Sided	95	0.35	1.04				No	Superiority or Other

Secondary

Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS (iTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment

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 six 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

Weeks 0-6

ID	Title	Description
OG000	Ciclesonide HFA 80 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
OG001	Ciclesonide HFA 160 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
OG002	Placebo Once Daily

Secondary

Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.

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 six 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

Weeks 0-6

ID	Title	Description
OG000	Ciclesonide HFA 80 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
OG001	Ciclesonide HFA 160 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
OG002	Placebo Once Daily

Secondary

Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.

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 six 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

Weeks 0-6

ID	Title	Description
OG000	Ciclesonide HFA 80 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
OG001	Ciclesonide HFA 160 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
OG002	Placebo Once Daily

Secondary

Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.

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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

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

Posted

Least Squares Mean

Standard Error

units on a scale

Weeks 0-6

ID	Title	Description
OG000	Ciclesonide HFA 80 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
OG001	Ciclesonide HFA 160 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
OG002	Placebo Once Daily

Secondary

Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.

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 six 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

Weeks 0-6

ID	Title	Description
OG000	Ciclesonide HFA 80 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
OG001	Ciclesonide HFA 160 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
OG002	Placebo Once Daily

Secondary

Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment

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 six 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

Weeks 0 - 6

ID	Title	Description
OG000	Ciclesonide HFA 80 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
OG001	Ciclesonide HFA 160 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
OG002	Placebo Once Daily	The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.

Secondary

Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment

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 six 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

Weeks 0-6

ID	Title	Description
OG000	Ciclesonide HFA 80 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
OG001	Ciclesonide HFA 160 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
OG002	Placebo Once Daily	The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.

Secondary

Change From Baseline in Daily Subject-reported AM & PM rNSS Averaged Over the First 6 Weeks of Double-blind 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 six 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

Weeks 0-6

ID	Title	Description
OG000	Ciclesonide HFA 80 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
OG001	Ciclesonide HFA 160 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
OG002	Placebo Once Daily	The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.

Secondary

Change From Baseline in Daily Subject-reported AM iNSS Averaged the First 6 Weeks of the Double-blind Treatment

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 Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

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

Posted

Least Squares Mean

Standard Error

units on a scale

Weeks 0-6

ID	Title	Description
OG000	Ciclesonide HFA 80 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
OG001	Ciclesonide HFA 160 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
OG002	Placebo Once Daily	The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.

Secondary

Change From Baseline in Daily Subject-reported PM iNSS Averaged the First 6 Weeks of the Double-blind Treatment

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 Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Intent to Treat Population.

Posted

Least Squares Mean

Standard Error

units on a scale

Weeks 0-6

ID	Title	Description
OG000	Ciclesonide HFA 80 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
OG001	Ciclesonide HFA 160 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
OG002	Placebo Once Daily	The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.

Secondary

Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the First 6 Weeks of Double-blind 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 Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

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

Posted

Least Squares Mean

Standard Error

units on a scale

Weeks 0-6

ID	Title	Description
OG000	Ciclesonide HFA 80 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
OG001	Ciclesonide HFA 160 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
OG002	Placebo Once Daily	The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.

Secondary

Change From Baseline to Week 6 in Rhinoconjunctivitis Quality of Life Questionnaire With Standardized [RQLQ(S)] Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0

RQLQ(S) scores 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.

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

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline and Week 6

ID	Title	Description
OG000	Ciclesonide HFA 80 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
OG001	Ciclesonide HFA 160 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
OG002	Placebo Once Daily

Secondary

Change From Baseline to Month 6 (Week 26) in RQLQ(S) Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0.

RQLQ(S) scores 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

Baseline and Week 26

ID	Title	Description
OG000	Ciclesonide HFA 80 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
OG001	Ciclesonide HFA 160 Mcg Once Daily	Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
OG002	Placebo Once Daily

Arm/Groups

ID	Title	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ciclesonide HFA 80 Mcg Once Daily	6	298	148	334
EG001	Ciclesonide HFA 160 Mcg Once Daily	8	505	234	475
EG002	Placebo Once Daily	6	307	131	243

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Artrioventricular block second degree	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected298 at risk EG0010 events0 affected505 at risk EG0021 events1 affected307 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected298 at risk EG0011 events1 affected505 at risk EG0020 events0 affected307 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected298 at risk EG0011 events1 affected505 at risk EG0020 events0 affected307 at risk
Suicidal ideation	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected298 at risk EG0010 events0 affected505 at risk EG0020 events0 affected307 at risk
Ovarian Cyst	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected298 at risk EG0010 events0 affected505 at risk EG0020 events0 affected307 at risk
Pelvic adhesions	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected298 at risk EG0010 events0 affected505 at risk EG0020 events0 affected307 at risk
Hypertension	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected298 at risk EG0010 events0 affected505 at risk EG0021 events1 affected307 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected298 at risk EG0011 events1 affected505 at risk EG0020 events0 affected307 at risk
Colonic atony	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected298 at risk EG0011 events1 affected505 at risk EG0020 events0 affected307 at risk
Megacolon	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected298 at risk EG0011 events1 affected505 at risk EG0020 events0 affected307 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected298 at risk EG0010 events0 affected505 at risk EG0022 events2 affected307 at risk
Vomiting	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected298 at risk EG0011 events1 affected505 at risk EG0020 events0 affected307 at risk
Hernia obstructive	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected298 at risk EG0010 events0 affected505 at risk EG0021 events1 affected307 at risk
Appendicitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected298 at risk EG0010 events0 affected505 at risk EG0020 events0 affected307 at risk
Pneumonia	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected298 at risk EG0010 events0 affected505 at risk EG0020 events0 affected307 at risk
Scleroderma	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected298 at risk EG0011 events1 affected505 at risk EG0020 events0 affected307 at risk
Embolic cerebral infarction	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected298 at risk EG0011 events1 affected505 at risk EG0020 events0 affected307 at risk
Mononeuropathy mulitplex	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected298 at risk EG0011 events1 affected505 at risk EG0020 events0 affected307 at risk
Abortion	Pregnancy, puerperium and perinatal conditions	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected298 at risk EG0011 events1 affected505 at risk EG0020 events0 affected307 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected298 at risk EG0010 events0 affected505 at risk EG0021 events1 affected307 at risk
Cystocele	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected298 at risk EG0011 events1 affected505 at risk EG0020 events0 affected307 at risk
Rectocele	Reproductive system and breast disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected298 at risk EG0011 events1 affected505 at risk EG0020 events0 affected307 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected298 at risk EG0010 events0 affected505 at risk EG0021 events1 affected307 at risk
Imprisonment	Social circumstances	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected298 at risk EG0011 events1 affected505 at risk EG0020 events0 affected307 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected334 at risk EG0018 events7 affected475 at risk EG0027 events7 affected243 at risk
Nausea	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG00010 events9 affected334 at risk EG0018 events8 affected475 at risk EG0022 events2 affected243 at risk
Instillation site discomfort	General disorders	MedDRA (12.1)	Systematic Assessment	EG00011 events10 affected334 at risk EG00111 events9 affected475 at risk EG0020 events0 affected243 at risk
Bronchitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0007 events7 affected334 at risk EG00111 events11 affected475 at risk EG0026 events6 affected243 at risk
Influenza	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0006 events6 affected334 at risk EG00111 events9 affected475 at risk EG0024 events3 affected243 at risk
Nasopharyngitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG00017 events14 affected334 at risk EG00135 events30 affected475 at risk EG00226 events19 affected243 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0008 events7 affected334 at risk EG0015 events5 affected475 at risk EG0026 events5 affected243 at risk
Sinusitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG00016 events14 affected334 at risk EG00130 events27 affected475 at risk EG00218 events17 affected243 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG00054 events43 affected334 at risk EG00174 events66 affected475 at risk EG00237 events29 affected243 at risk
Urinary tract infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG00013 events13 affected334 at risk EG00116 events14 affected475 at risk EG00210 events9 affected243 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG00016 events15 affected334 at risk EG00114 events13 affected475 at risk EG0029 events7 affected243 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0007 events6 affected334 at risk EG0019 events7 affected475 at risk EG0022 events2 affected243 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG00012 events5 affected334 at risk EG00111 events11 affected475 at risk EG00212 events10 affected243 at risk
Headache	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG00036 events21 affected334 at risk EG00127 events17 affected475 at risk EG00218 events14 affected243 at risk
Sinus headache	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG00010 events6 affected334 at risk EG0017 events4 affected475 at risk EG0028 events7 affected243 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0009 events9 affected334 at risk EG00119 events19 affected475 at risk EG0029 events8 affected243 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG00057 events34 affected334 at risk EG00198 events57 affected475 at risk EG00242 events24 affected243 at risk
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0009 events8 affected334 at risk EG00116 events16 affected475 at risk EG0022 events2 affected243 at risk
Nasal mucosal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0007 events7 affected334 at risk EG00114 events12 affected475 at risk EG0022 events2 affected243 at risk
Nasal septum disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0006 events5 affected334 at risk EG00121 events16 affected475 at risk EG0024 events3 affected243 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG00015 events12 affected334 at risk EG00122 events20 affected475 at risk EG00211 events10 affected243 at risk
Hypertension	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected334 at risk EG0018 events7 affected475 at risk EG0028 events8 affected243 at risk

This study was not designed or powered for a comparison of the 80mcg dose with the 160mcg dose therefore no statistical comparisons were planned between the two active groups. Publication references to 74 and 148mcg are equivalent to 80 and 160mcg

Certain Agreements

ID	Term
D065631	Rhinitis, Allergic
D012221	Rhinitis, Allergic, Perennial

Ancestor Terms

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

The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.