CompletedNCT01033825Updated Jul 19, 2012Results posted

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

A Phase 3 interventional study of Ciclesonide HFA Nasal Aerosol 320 mcg and Ciclesonide HFA Nasal Aerosol 160 mcg in Perennial Allergic Rhinitis, sponsored by Sumitomo Pharma America, Inc.. Completed at 6 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2012-07-19.

Sponsored by Sumitomo Pharma America, Inc. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 310
Allocation: Randomized
Ages: 12 Years and older
Sex: All

Study summary

To demonstrate the effects of ciclesonide applied as a nasal aerosol and ciclesonide aqueous (AQ) nasal spray on hypothalamic-pituitary-adrenal axis.

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety and efficacy study of the effects of ciclesonide HFA nasal aerosol and ciclesonide AQ nasal spray on the HPA axis, when administered once daily to male and female subjects 12 years or older diagnosed with Perennial Allergic Rhinitis (PAR). The study consists of a screening period, a single blind run in period, a 6 week double blind treatment period including an active control segment, and a follow up period.

Placebo was used as the control during the double-blind treatment period for both delivery methods (HFA nasal aerosol and aqueous nasal spray)and for the study outcome analyses. There was also a positive control administered to a subset of these placebo subjects during the last 4 days of Week 6 (dexamethasone placebo or dexamethasone 6 mg). The active control was utilized to validate the assay sensitivity (ie, distinguish an effective from an ineffective drug) of this study, as dexamethasone is a known HPA axis suppressant, therefore this subset of placebo subjects was not included in the study outcome analyses.

This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Conditions studied

Perennial Allergic Rhinitis

Browse trials for

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 310 is above the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Sumitomo Pharma America, Inc. is the lead sponsor of 176 studies on the registry; 5 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 20 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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 (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 screening 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 to at least one allergen known to induce PAR (house dust mite, animal dander, cockroach, and molds) based on a documented result with a standard skin-prick test either within 90 days prior to screening or performed at the Screening visit. A positive test is defined as a wheal diameter at least 3 mm larger than the negative control wheal for the 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.
Subject, if female, 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.
1. 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.
2. Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
3. Abstinence.

Exclusion criteria

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 120 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 randomization 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 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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 310 participants (actual)

Study arms

Experimental
Ciclesonide HFA Nasal Aerosol 320 mcg
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Drug: Ciclesonide HFA Nasal Aerosol 320 mcg
Experimental
Ciclesonide HFA Nasal Aerosol 160 mcg
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
Drug: Ciclesonide HFA Nasal Aerosol 160 mcg
Placebo comparator
HFA Nasal Aerosol placebo
HFA Nasal Aerosol Placebo once daily
Drug: HFA Nasal Aerosol placebo
Experimental
Ciclesonide Aqueous Nasal Spray 200 mcg
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
Drug: Ciclesonide Aqueous Nasal Spray 200 mcg
Placebo comparator
AQ Nasal Spray Placebo
AQ Nasal Spray Placebo once daily
Drug: AQ Nasal Spray Placebo
Active comparator
Placebo HFA plus Dexamethasone 6 mcg
Placebo HFA plus Dexamethasone 6 mg once daily
Drug: Placebo plus Dexamethasone HFA
Active comparator
Placebo AQ plus Dexamethasone 6 mg
Placebo AQ plus Dexamethasone 6 mg once daily
Drug: Placebo AQ plus Dexamethasone 6 mg

Interventions

DrugCiclesonide HFA Nasal Aerosol 320 mcg
Ciclesonide HFA Nasal Aerosol 320 μg once daily
DrugCiclesonide HFA Nasal Aerosol 160 mcg
Ciclesonide HFA Nasal Aerosol 160 μg once daily
DrugHFA Nasal Aerosol placebo
HFA Nasal Aerosol placebo once daily
DrugCiclesonide Aqueous Nasal Spray 200 mcg
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
Also known as: Omnaris
DrugAQ Nasal Spray Placebo
AQ Nasal Spray Placebo once daily
DrugPlacebo plus Dexamethasone HFA
Dexamethasone capsules 6 mg once daily
Also known as: Decadron
DrugPlacebo AQ plus Dexamethasone 6 mg
Placebo AQ plus Dexamethasone 6 mcg capsules once daily

What researchers measure

Primary outcomes

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

Secondary outcomes

Number of Subjects Experiencing Adverse Events (AEs)
Time frame: Weeks 0-6
Percentage of Subjects Experiencing Adverse Events (AEs)
Time frame: Weeks 0-6
Number of Subjects Experiencing Serious Adverse Events (SAEs).
Time frame: Weeks 0-6
Percentage of Subjects Experiencing Serious Adverse Events (SAEs).
Time frame: Weeks 0-6
Number of Subjects Who Discontinue Due to AEs
Time frame: Weeks 0-6
Percentage of Subjects Who Discontinue Due to AEs
Time frame: Weeks 0-6
Number of Subjects Experiencing Local Nasal AEs
Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.
Time frame: Weeks 0-6
Percentage of Subjects Experiencing Local Nasal AEs
Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.
Time frame: Weeks 0-6
Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline
Time frame: Baseline
Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment
Time frame: Weeks 0-6
Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline
Time frame: Baseline
Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment
Time frame: Weeks 0-6
Baseline Daily Subject-reported AM Reflective TNSS
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Baseline
Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 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 symptom on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Weeks 0-6
Baseline Daily Subject-reported PM Reflective TNSS
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Baseline
Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 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 symptom on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Weeks 0-6
Baseline Daily Subject-reported AM Instantaneous TNSS
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Baseline
Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 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 symptom on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Weeks 0-6
Baseline Daily Subject-reported AM and PM Reflective TNSS
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Baseline
Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over Each Week, and Averaged Over the 6 Weeks of Double-blind Treatment
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Weeks 0-6
Baseline Daily Subject-reported PM Instantaneous TNSS
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Baseline
Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 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 symptom on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Weeks 0-6
Baseline Daily Subject-reported AM and PM Instantaneous TNSS
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Baseline
Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 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 symptom on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Weeks 0-6
Baseline Daily Subject-reported Individual AM Reflective NSS
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident); 1. = mild 2. = moderate 3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Baseline
Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 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 (no sign/symptom evident); 1. = mild 2. = moderate 3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Weeks 0-6
Baseline Daily Subject-reported Individual PM Reflective NSS
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident); 1. = mild 2. = moderate 3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Baseline
Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 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 (no sign/symptom evident); 1. = mild 2. = moderate 3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Weeks 0-6
Baseline Daily Subject-reported Individual AM and PM Reflective NSS
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident); 1. = mild 2. = moderate 3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Baseline
Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 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 (no sign/symptom evident); 1. = mild 2. = moderate 3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Weeks 0-6
Baseline Daily Subject-reported Individual AM Instantaneous NSS
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident); 1. = mild 2. = moderate 3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Baseline
Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of 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 (no sign/symptom evident); 1. = mild 2. = moderate 3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Weeks 0-6
Baseline Daily Subject-reported Individual PM Instantaneous NSS
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident); 1. = mild 2. = moderate 3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Baseline
Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of 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 (no sign/symptom evident); 1. = mild 2. = moderate 3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Weeks 0-6
Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident); 1. = mild 2. = moderate 3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Baseline
Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of 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 (no sign/symptom evident); 1. = mild 2. = moderate 3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Weeks 0-6
Time to Maximal Effect Over 6 Weeks of Double-blind Treatment.
The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between each active treatment group and corresponding placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The evaluation is made separately for each dose level of Ciclesonide HFA compared to placebo. Difference is calculated as placebo - ciclesonide. Analysis of HFA data and AQ data were conducted separately.
Time frame: Weeks 0-6
Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances.
Ratio of correct advance is defined as the (number of doses actuated/number of dose reported).
Time frame: Weeks 1-2, 2-4
Number of Devices With Actuation Consistency
Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration.
Time frame: Weeks 1-4
Percentage of Devices With Actuation Consistency
Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration.
Time frame: Weeks 1-4
Number of Devices With Major Discrepancies
A major discrepancy is defined as a discrepancy of \>20 actuations between the dose indicator and subject self report of study medication administration.
Time frame: Week 6
Percentage of Devices With Major Discrepancies
A major discrepancy is defined as a discrepancy of \>20 actuations between the dose indicator and subject self report of study medication administration.
Time frame: Week 6

Results

Posted Jul 19, 2012

Limitations and caveats

Dose levels investigated were higher than the US FDA approved dose (74 mcg once daily) for allergic rhinitis subjects. Publication references to 148 and 282mcg are equivalent to 160 and 320mcg.

Participant flow

Participant flow — Overall Study
Milestone	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo	Placebo HFA Plus Dexamethasone 6 mg	Placebo AQ Plus Dexamethasone 6 mg
Started	51	60	57	48	58	18	18
Completed	48	57	55	46	56	18	18
Not completed	3	3	2	2	2	0	0
Withdrew: Withdrawal by subject	2	3	2	1	1	0	0
Withdrew: Adverse event	0	0	0	1	0	0	0
Withdrew: Protocol violation	1	0	0	0	0	0	0
Withdrew: Other	0	0	0	0	1	0	0

Outcome measures

PrimarySerum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline

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

Time frame:: Baseline
Reported as:: Mean · mcg•h/dL

Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline
mcg•h/dL	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	Placebo Aqueous Nasal Spray
Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline	183.2 ± 61.9	171.7 ± 40.1	173.1 ± 53.5	172.8 ± 42.5	179.0 ± 37.9

SecondaryNumber of Subjects Experiencing Adverse Events (AEs)

Time frame:: Weeks 0-6
Reported as:: Number · participants

Number of Subjects Experiencing Adverse Events (AEs)
participants	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	Placebo Aqueous Nasal Spray
Number of Subjects Experiencing Adverse Events (AEs)	23	17	23	19	29

SecondaryPercentage of Subjects Experiencing Adverse Events (AEs)

Time frame:: Weeks 0-6
Reported as:: Number · percentage of subjects

Percentage of Subjects Experiencing Adverse Events (AEs)
percentage of subjects	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Percentage of Subjects Experiencing Adverse Events (AEs)	45.1	28.3	30.7	39.6	38.2

SecondaryNumber of Subjects Experiencing Serious Adverse Events (SAEs).

Time frame:: Weeks 0-6
Reported as:: Number · participants

Number of Subjects Experiencing Serious Adverse Events (SAEs).
participants	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Number of Subjects Experiencing Serious Adverse Events (SAEs).	0	0	0	0	0

SecondaryPercentage of Subjects Experiencing Serious Adverse Events (SAEs).

Time frame:: Weeks 0-6
Reported as:: Number · percentage of subjects

Percentage of Subjects Experiencing Serious Adverse Events (SAEs).
percentage of subjects	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Percentage of Subjects Experiencing Serious Adverse Events (SAEs).	0	0	0	0	0

SecondaryNumber of Subjects Who Discontinue Due to AEs

Time frame:: Weeks 0-6
Reported as:: Number · participants

Number of Subjects Who Discontinue Due to AEs
participants	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Number of Subjects Who Discontinue Due to AEs	0	0	0	1	0

SecondaryPercentage of Subjects Who Discontinue Due to AEs

Time frame:: Weeks 0-6
Reported as:: Number · percentage of subjects

Percentage of Subjects Who Discontinue Due to AEs
percentage of subjects	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Percentage of Subjects Who Discontinue Due to AEs	0	0	0	2.1	0

SecondaryNumber of Subjects Experiencing Local Nasal AEs

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

Time frame:: Weeks 0-6
Reported as:: Number · participants

Number of Subjects Experiencing Local Nasal AEs
participants	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo	Placebo HFA Plus 6 mg Dexamethasone	Placebo AQ Plus 6 mg Dexamethasone
Number of Subjects Experiencing Local Nasal AEs	21	11	8	16	11	5	1

SecondaryPercentage of Subjects Experiencing Local Nasal AEs

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

Time frame:: Weeks 0-6
Reported as:: Number · percentage of subjects

Percentage of Subjects Experiencing Local Nasal AEs
percentage of subjects	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo	Placebo HFA Plus 6 mg Dexamethasone	Placebo AQ Plus 6 mg Dexamethasone
Percentage of Subjects Experiencing Local Nasal AEs	41.2	18.3	14.0	33.3	19.0	27.8	5.6

SecondarySerum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline

Time frame:: Baseline
Reported as:: Mean · mcg•h/dL

Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline
mcg•h/dL	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline	99.8 ± 38.3	95.1 ± 28.5	92.0 ± 31.3	91.9 ± 25.8	97.2 ± 25.0

SecondaryChange in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment

Time frame:: Weeks 0-6
Reported as:: Least squares mean · mcg•h/dL

Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment
mcg•h/dL	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment	-1.0 ± 3.2	-1.3 ± 3.0	0.5 ± 3.0	-5.8 ± 3.0	-2.9 ± 2.7

SecondarySerum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline

Time frame:: Baseline
Reported as:: Mean · mcg•h/dL

Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline
mcg•h/dL	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline	83.4 ± 30.2	76.2 ± 24.0	81.1 ± 28.7	80.9 ± 26.8	81.8 ± 22.8

SecondaryChange in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment

Time frame:: Weeks 0-6
Reported as:: Least squares mean · mcg•h/dL

Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment
mcg•h/dL	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment	-3.9 ± 2.9	-2.0 ± 2.7	-5.9 ± 2.7	-6.1 ± 3.7	2.2 ± 3.4

SecondaryBaseline Daily Subject-reported AM Reflective TNSS

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

Time frame:: Baseline
Reported as:: Mean · units on a scale

Baseline Daily Subject-reported AM Reflective TNSS
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Baseline Daily Subject-reported AM Reflective TNSS	7.55 ± 2.39	8.03 ± 2.27	7.81 ± 2.47	7.91 ± 2.50	7.84 ± 2.58

SecondaryChange From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment

Time frame:: Weeks 0-6
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment	-1.80 ± 0.29	-1.75 ± 0.26	-0.35 ± 0.27	-1.18 ± 0.30	-0.91 ± 0.28

SecondaryBaseline Daily Subject-reported PM Reflective TNSS

Time frame:: Baseline
Reported as:: Mean · units on a scale

Baseline Daily Subject-reported PM Reflective TNSS
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Baseline Daily Subject-reported PM Reflective TNSS	7.82 ± 2.40	8.39 ± 2.11	7.83 ± 2.52	8.13 ± 2.66	8.16 ± 2.51

SecondaryChange From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment

Time frame:: Weeks 0-6
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment	-1.77 ± 0.30	-1.88 ± 0.28	-0.31 ± 0.28	-1.14 ± 0.29	-1.19 ± 0.26

SecondaryBaseline Daily Subject-reported AM Instantaneous TNSS

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

Time frame:: Baseline
Reported as:: Mean · units on a scale

Baseline Daily Subject-reported AM Instantaneous TNSS
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Baseline Daily Subject-reported AM Instantaneous TNSS	6.91 ± 2.68	7.63 ± 2.35	7.37 ± 2.68	7.24 ± 2.43	7.19 ± 2.84

SecondaryChange From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 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 symptom on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Time frame:: Weeks 0-6
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment	-1.52 ± 0.27	-1.62 ± 0.25	-0.26 ± 0.25	-1.23 ± 0.29	-0.60 ± 0.26

SecondaryBaseline Daily Subject-reported AM and PM Reflective TNSS

Time frame:: Baseline
Reported as:: Mean · units on a scale

Baseline Daily Subject-reported AM and PM Reflective TNSS
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Baseline Daily Subject-reported AM and PM Reflective TNSS	7.68 ± 2.33	8.20 ± 2.14	7.82 ± 2.45	8.01 ± 2.52	8.01 ± 2.49

SecondaryChange From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over Each Week, and Averaged Over the 6 Weeks of Double-blind Treatment

Time frame:: Weeks 0-6
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over Each Week, and Averaged Over the 6 Weeks of Double-blind Treatment
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over Each Week, and Averaged Over the 6 Weeks of Double-blind Treatment	-1.78 ± 0.29	-1.82 ± 0.27	-0.33 ± 0.27	-1.16 ± 0.29	-1.06 ± 0.27

SecondaryBaseline Daily Subject-reported PM Instantaneous TNSS

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

Time frame:: Baseline
Reported as:: Mean · units on a scale

Baseline Daily Subject-reported PM Instantaneous TNSS
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Baseline Daily Subject-reported PM Instantaneous TNSS	6.84 ± 3.09	7.60 ± 2.37	7.13 ± 2.75	7.38 ± 2.68	7.44 ± 2.74

SecondaryChange From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 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 symptom on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Time frame:: Weeks 0-6
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment	-1.39 ± 0.28	-1.67 ± 0.26	-0.10 ± 0.26	-1.09 ± 0.30	-0.88 ± 0.28

SecondaryBaseline Daily Subject-reported AM and PM Instantaneous TNSS

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

Time frame:: Baseline
Reported as:: Mean · units on a scale

Baseline Daily Subject-reported AM and PM Instantaneous TNSS
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Baseline Daily Subject-reported AM and PM Instantaneous TNSS	6.87 ± 2.84	7.62 ± 2.29	7.26 ± 2.67	7.30 ± 2.52	7.33 ± 2.74

SecondaryChange From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 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 symptom on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Time frame:: Weeks 0-6
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment	-1.45 ± 0.27	-1.67 ± 0.25	-0.19 ± 0.25	-1.15 ± 0.29	-0.75 ± 0.27

SecondaryBaseline Daily Subject-reported Individual AM Reflective NSS

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident); 1. = mild 2. = moderate 3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.

Time frame:: Baseline
Reported as:: Mean · units on a scale

Baseline Daily Subject-reported Individual AM Reflective NSS
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Baseline Nasal Sneezing	1.56 ± 0.83	1.65 ± 0.88	1.54 ± 0.89	1.42 ± 0.81	1.57 ± 0.93
Baseline Runny Nose	1.99 ± 0.68	2.16 ± 0.63	2.15 ± 0.70	2.27 ± 0.71	2.06 ± 0.76
Baseline Nasal Itching	1.71 ± 0.85	1.89 ± 0.75	1.83 ± 0.83	1.85 ± 0.85	1.92 ± 0.83
Baseline Nasal Congestion	2.30 ± 0.59	2.32 ± 0.57	2.29 ± 0.60	2.36 ± 0.66	2.29 ± 0.62

SecondaryChange From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period

Time frame:: Weeks 0-6
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Nasal Sneezing	-0.41 ± 0.09	-0.41 ± 0.08	-0.09 ± 0.08	-0.28 ± 0.08	-0.25 ± 0.08
Runny Nose	-0.50 ± 0.08	-0.50 ± 0.08	-0.17 ± 0.08	-0.36 ± 0.10	-0.29 ± 0.09
Nasal Itching	-0.40 ± 0.08	-0.40 ± 0.08	-0.05 ± 0.08	-0.33 ± 0.09	-0.25 ± 0.08
Nasal Congestion	-0.49 ± 0.07	-0.42 ± 0.07	-0.05 ± 0.07	-0.20 ± 0.09	-0.13 ± 0.08

SecondaryBaseline Daily Subject-reported Individual PM Reflective NSS

Time frame:: Baseline
Reported as:: Mean · units on a scale

Baseline Daily Subject-reported Individual PM Reflective NSS
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Baseline Nasal Sneezing	1.82 ± 0.71	1.87 ± 0.76	1.69 ± 0.81	1.59 ± 0.83	1.74 ± 0.87
Baseline Runny Nose	2.03 ± 0.66	2.20 ± 0.58	2.11 ± 0.71	2.30 ± 0.74	2.16 ± 0.73
Baseline Nasal Itching	1.75 ± 0.83	2.02 ± 0.75	1.80 ± 0.82	1.93 ± 0.87	2.00 ± 0.78
Baseline Nasal Congestion	2.23 ± 0.72	2.30 ± 0.54	2.23 ± 0.67	2.31 ± 0.73	2.25 ± 0.63

PrimaryThe Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) From Baseline to Week 6 of the Double Blind Treatment Period

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

Time frame:: week 6
Reported as:: Least squares mean · mcg•h/dL

The Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) From Baseline to Week 6 of the Double Blind Treatment Period
mcg•h/dL	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	Placebo Aqueous Nasal Spray
The Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) From Baseline to Week 6 of the Double Blind Treatment Period	-4.6 ± 5.0	-2.6 ± 4.6	-5.0 ± 4.6	-11.4 ± 5.7	-1.0 ± 5.2

Statistical analysis

Ciclesonide HFA Nasal Aerosol 320 Mcg vs HFA Nasal Aerosol Placebo · ANCOVA · p = >0.05 · Mean difference (final values): -0.5 · 95% CI -13.9 to 13.0Null Hypothesis: the difference in serum cortisol levels between placebo and active (placebo-active)\>=38 Alternative Hypothesis: the difference in serum cortisol levels between placebo and active (placebo-active)\<38
Ciclesonide HFA Nasal Aerosol 160 Mcg vs HFA Nasal Aerosol Placebo · ANCOVA · p = 0.025 · Mean difference (final values): -2.4 · 95% CI -15.1 to 10.2
Ciclesonide Aqueous Nasal Spray 200 Mcg vs Placebo Aqueous Nasal Spray · ANCOVA · p = >0.05 · Mean difference (final values): 10.4 · 95% CI -4.7 to 25.5

SecondaryChange From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period

Time frame:: Weeks 0-6
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Nasal Sneezing	-0.45 ± 0.09	-0.48 ± 0.08	-0.13 ± 0.08	-0.23 ± 0.08	-0.27 ± 0.08
Runny Nose	-0.49 ± 0.08	-0.48 ± 0.08	-0.09 ± 0.08	-0.37 ± 0.09	-0.37 ± 0.08
Nasal Itching	-0.38 ± 0.08	-0.46 ± 0.08	-0.05 ± 0.08	-0.32 ± 0.09	-0.34 ± 0.08
Nasal Congestion	-0.44 ± 0.08	-0.44 ± 0.07	-0.04 ± 0.07	-0.20 ± 0.09	-0.21 ± 0.08

SecondaryBaseline Daily Subject-reported Individual AM and PM Reflective NSS

Time frame:: Baseline
Reported as:: Mean · units on a scale

Baseline Daily Subject-reported Individual AM and PM Reflective NSS
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Baseline Nasal Sneezing	1.69 ± 0.73	1.76 ± 0.79	1.62 ± 0.83	1.51 ± 0.78	1.66 ± 0.87
Baseline Runny Nose	2.01 ± 0.65	2.18 ± 0.59	2.13 ± 0.69	2.29 ± 0.70	2.11 ± 0.72
Baseline Nasal Itching	1.73 ± 0.83	1.95 ± 0.73	1.82 ± 0.80	1.89 ± 0.85	1.96 ± 0.79
Baseline Nasal Congestion	2.26 ± 0.63	2.31 ± 0.53	2.26 ± 0.62	2.33 ± 0.67	2.27 ± 0.61

SecondaryChange From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period

Time frame:: Weeks 0-6
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Nasal Sneezing	-0.43 ± 0.09	-0.45 ± 0.08	-0.11 ± 0.08	-0.25 ± 0.08	-0.26 ± 0.07
Runny Nose	-0.50 ± 0.08	-0.50 ± 0.07	-0.13 ± 0.08	-0.37 ± 0.09	-0.33 ± 0.08
Nasal Itching	-0.39 ± 0.08	-0.43 ± 0.08	-0.05 ± 0.08	-0.32 ± 0.09	-0.30 ± 0.08
Nasal Congestion	-0.47 ± 0.07	-0.43 ± 0.07	-0.04 ± 0.07	-0.20 ± 0.09	-0.17 ± 0.08

SecondaryBaseline Daily Subject-reported Individual AM Instantaneous NSS

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident); 1. = mild 2. = moderate 3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.

Time frame:: Baseline
Reported as:: Mean · units on a scale

Baseline Daily Subject-reported Individual AM Instantaneous NSS
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Baseline Nasal Sneezing	1.24 ± 0.82	1.43 ± 0.96	1.34 ± 0.94	1.15 ± 0.85	1.30 ± 1.02
Baseline Runny Nose	1.83 ± 0.84	2.08 ± 0.66	2.01 ± 0.74	2.08 ± 0.68	1.93 ± 0.89
Baseline Nasal Itching	1.61 ± 0.86	1.85 ± 0.75	1.76 ± 0.89	1.76 ± 0.89	1.76 ± 0.91
Baseline Nasal Congestion	2.24 ± 0.67	2.27 ± 0.58	2.27 ± 0.60	2.25 ± 0.66	2.20 ± 0.66

SecondaryChange From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of 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 (no sign/symptom evident); 1. = mild 2. = moderate 3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.

Time frame:: Weeks 0-6
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Nasal Sneezing	-0.32 ± 0.08	-0.37 ± 0.07	-0.06 ± 0.08	-0.24 ± 0.08	-0.17 ± 0.07
Runny Nose	-0.43 ± 0.08	-0.47 ± 0.08	-0.12 ± 0.08	-0.36 ± 0.10	-0.23 ± 0.09
Nasal Itching	-0.38 ± 0.08	-0.40 ± 0.07	-0.03 ± 0.08	-0.40 ± 0.09	-0.14 ± 0.08
Nasal Congestion	-0.41 ± 0.07	-0.37 ± 0.07	-0.05 ± 0.07	-0.20 ± 0.08	-0.06 ± 0.07

SecondaryBaseline Daily Subject-reported Individual PM Instantaneous NSS

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident); 1. = mild 2. = moderate 3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.

Time frame:: Baseline
Reported as:: Mean · units on a scale

Baseline Daily Subject-reported Individual PM Instantaneous NSS
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Baseline Nasal Sneezing	1.42 ± 0.89	1.51 ± 0.86	1.40 ± 0.93	1.30 ± 0.85	1.47 ± 0.92
Baseline Runny Nose	1.80 ± 0.85	2.03 ± 0.73	1.98 ± 0.72	2.13 ± 0.75	2.01 ± 0.76
Baseline Nasal Itching	1.60 ± 0.90	1.88 ± 0.78	1.64 ± 0.84	1.79 ± 0.87	1.84 ± 0.91
Baseline Nasal Congestion	2.02 ± 0.82	2.19 ± 0.59	2.11 ± 0.68	2.16 ± 0.76	2.12 ± 0.65

SecondaryChange From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of 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 (no sign/symptom evident); 1. = mild 2. = moderate 3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.

Time frame:: Weeks 0-6
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Nasal Sneezing	-0.33 ± 0.08	-0.37 ± 0.08	-0.07 ± 0.08	-0.24 ± 0.08	-0.22 ± 0.08
Runny Nose	-0.41 ± 0.08	-0.45 ± 0.07	-0.08 ± 0.08	-0.33 ± 0.10	-0.30 ± 0.09
Nasal Itching	-0.32 ± 0.08	-0.44 ± 0.07	0.02 ± 0.07	-0.35 ± 0.09	-0.25 ± 0.08
Nasal Congestion	-0.34 ± 0.07	-0.39 ± 0.07	0.02 ± 0.07	-0.15 ± 0.09	-0.12 ± 0.08

SecondaryBaseline Daily Subject-reported Individual AM and PM Instantaneous NSS

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident); 1. = mild 2. = moderate 3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.

Time frame:: Baseline
Reported as:: Mean · units on a scale

Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Baseline Nasal Sneezing	1.33 ± 0.83	1.47 ± 0.89	1.37 ± 0.91	1.22 ± 0.83	1.38 ± 0.95
Baseline Runny Nose	1.81 ± 0.83	2.05 ± 0.67	2.00 ± 0.72	2.10 ± 0.69	1.98 ± 0.80
Baseline Nasal Itching	1.61 ± 0.86	1.87 ± 0.75	1.70 ± 0.84	1.78 ± 0.87	1.80 ± 0.89
Baseline Nasal Congestion	2.13 ± 0.72	2.23 ± 0.55	2.19 ± 0.62	2.20 ± 0.68	2.16 ± 0.63

SecondaryChange From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of 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 (no sign/symptom evident); 1. = mild 2. = moderate 3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.

Time frame:: Weeks 0-6
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment
units on a scale	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
Nasal Sneezing	-0.32 ± 0.08	-0.37 ± 0.07	-0.06 ± 0.07	-0.23 ± 0.08	-0.20 ± 0.07
Runny Nose	-0.42 ± 0.08	-0.47 ± 0.07	-0.10 ± 0.07	-0.35 ± 0.09	-0.27 ± 0.09
Nasal Itching	-0.35 ± 0.08	-0.42 ± 0.07	-0.01 ± 0.07	-0.37 ± 0.09	-0.20 ± 0.08
Nasal Congestion	-0.37 ± 0.07	-0.39 ± 0.06	-0.01 ± 0.06	-0.17 ± 0.08	-0.09 ± 0.08

SecondaryTime to Maximal Effect Over 6 Weeks of Double-blind Treatment.

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

Time frame:: Weeks 0-6
Reported as:: Number · Number of days

Time to Maximal Effect Over 6 Weeks of Double-blind Treatment.
Number of days	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	Ciclesonide Aqueous Nasal Spray 200 Mcg
Time to Maximal Effect Over 6 Weeks of Double-blind Treatment.	15	29	7

SecondaryRatio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances.

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

Time frame:: Weeks 1-2, 2-4
Reported as:: Mean · percentage of correct advances

Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances.
percentage of correct advances	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo
Weeks 1-2 (n=49,58,75)	106.3 ± 10.8	106.2 ± 12.1	105.3 ± 15.8
Weeks 2-4 (n=46,52,71)	105.6 ± 11.8	105.9 ± 10.5	105.8 ± 11.7

SecondaryNumber of Devices With Actuation Consistency

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

Time frame:: Weeks 1-4
Reported as:: Number · Devices

Number of Devices With Actuation Consistency
Devices	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	Ciclesonide Aqueous Nasal Spray 200 Mcg
Number of Devices With Actuation Consistency	42	48	68

SecondaryPercentage of Devices With Actuation Consistency

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

Time frame:: Weeks 1-4
Reported as:: Number · percentage of devices

Percentage of Devices With Actuation Consistency
percentage of devices	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo
Percentage of Devices With Actuation Consistency	91.3	92.3	95.8

SecondaryNumber of Devices With Major Discrepancies

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

Time frame:: Week 6
Reported as:: Number · Devices

Number of Devices With Major Discrepancies
Devices	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	Ciclesonide Aqueous Nasal Spray 200 Mcg
Number of Devices With Major Discrepancies	0	2	1

SecondaryPercentage of Devices With Major Discrepancies

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

Time frame:: Week 6
Reported as:: Number · percentage of devices

Percentage of Devices With Major Discrepancies
percentage of devices	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo
Percentage of Devices With Major Discrepancies	0	3.8	1.4

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Ciclesonide HFA Nasal Aerosol 320 Mcg	—	0/48 (0%)	24/51 (47.1%)
Ciclesonide HFA Nasal Aerosol 160 Mcg	—	0/57 (0%)	22/60 (36.7%)
HFA Nasal Aerosol Placebo	—	0/18 (0%)	16/57 (28.1%)
Ciclesonide Aqueous Nasal Spray 200 Mcg	—	0/47 (0%)	25/48 (52.1%)
AQ Nasal Spray Placebo	—	0/57 (0%)	22/58 (37.9%)

Most frequent other events

Showing 10 of 46

Most frequent other events
Event	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo
EpistaxisRespiratory, thoracic and mediastinal disorders	12/51	4/60	3/57	9/48	3/58
HeadacheNervous system disorders	2/51	2/60	3/57	4/48	7/58
NasopharyngitisInfections and infestations	4/51	2/60	2/57	1/48	3/58
VomitingGastrointestinal disorders	0/51	0/60	0/57	3/48	0/58
NauseaGastrointestinal disorders	1/51	2/60	2/57	2/48	2/58
Otitis MediaInfections and infestations	0/51	1/60	0/57	2/48	0/58
Back painMusculoskeletal and connective tissue disorders	0/51	1/60	0/57	2/48	2/58
CoughRespiratory, thoracic and mediastinal disorders	0/51	0/60	0/57	2/48	0/58
Instillation site discomfortGeneral disorders	2/51	2/60	1/57	0/48	0/58
Nasal septum disorderRespiratory, thoracic and mediastinal disorders	2/51	0/60	1/57	1/48	2/58

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo	Placebo HFA Plus Dexamethasone 6 mg	Placebo AQ Plus Dexamethasone 6 mg	Total
<=18 years	4	10	12	8	9	2	3	48
Between 18 and 65 years	47	50	43	40	48	16	15	259
>=65 years	0	0	2	0	1	0	0	3

Age Continuous
Age Continuous(years)	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo	Placebo HFA Plus Dexamethasone 6 mg	Placebo AQ Plus Dexamethasone 6 mg	Total
Mean	35.8 ± 13.62	34.5 ± 13.42	33.0 ± 15.69	32.3 ± 12.53	35.5 ± 14.55	35.4 ± 12.94	34.0 ± 134.41	34.26 ± 14.01

Sex: Female, Male
Sex: Female, Male(Participants)	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo	Placebo HFA Plus Dexamethasone 6 mg	Placebo AQ Plus Dexamethasone 6 mg	Total
Female	32	37	37	30	33	6	12	187
Male	19	23	20	18	25	12	6	123

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo	Placebo HFA Plus Dexamethasone 6 mg	Placebo AQ Plus Dexamethasone 6 mg	Total
Hispanic or Latino	11	16	6	11	10	3	3	60
Not Hispanic or Latino	40	44	51	37	48	15	15	250
Unknown or Not Reported	0	0	0	0	0	0	0	0

Race/Ethnicity, customized
Race/Ethnicity, customized(particpants)	Ciclesonide HFA Nasal Aerosol 320 Mcg	Ciclesonide HFA Nasal Aerosol 160 Mcg	HFA Nasal Aerosol Placebo	Ciclesonide Aqueous Nasal Spray 200 Mcg	AQ Nasal Spray Placebo	Placebo HFA Plus Dexamethasone 6 mg	Placebo AQ Plus Dexamethasone 6 mg	Total
White/Caucasian	49	51	52	42	52	15	15	276
Black or African American	1	4	5	4	5	2	1	22
Asian	1	5	0	0	0	0	0	6
American Indian or Alaska Native	0	0	0	1	1	0	0	2
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0
Other	0	0	0	0	0	0	1	1
Multiple	0	0	0	1	0	1	1	3

Study locations

6 sites

Clinical Research Atlanta
Stockbridge, Georgia 30281, United States
Northeast Medical Research Associates
North Dartmouth, Massachusetts 02747, United States
Clinical Research Institute
Minneappolis, Minnesota 55402, United States
Princeton Center for Clinical Research
Skillman, New Jersey 08558, United States
Central Texas Health Research
New Braunfels, Texas 78130, United States
Sylvana Research
San Antonio, Texas 78229, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01033825
Lead sponsor: Sumitomo Pharma America, Inc.
Responsible party: Sponsor
First posted: Dec 17, 2009
Start date: Jan 2010
Primary completion: May 2010
Completion: May 2010
Results posted: Jul 19, 2012
Last update: Jul 19, 2012

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Rhinitis→

Other studies from this sponsor

Sumitomo Pharma America, Inc.

Start the discussion

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

Study summary

Conditions studied

Browse trials for

In context

Rhinitis

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

Updates

Registry details

Key details

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria