Perennial Allergic Rhinitis
Conditions
Brief summary
To demonstrate the effects of ciclesonide applied as a nasal aerosol and ciclesonide aqueous (AQ) nasal spray on hypothalamic-pituitary-adrenal axis.
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.
Interventions
DRUGPlacebo AQ plus Dexamethasone 6 mg
Placebo AQ plus Dexamethasone 6 mcg capsules once daily
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
DRUGAQ Nasal Spray Placebo
AQ Nasal Spray Placebo once daily
DRUGPlacebo plus Dexamethasone HFA
Dexamethasone capsules 6 mg once daily
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline | 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). |
| 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 | week 6 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Experiencing Serious Adverse Events (SAEs). | Weeks 0-6 | — |
| Percentage of Subjects Experiencing Serious Adverse Events (SAEs). | Weeks 0-6 | — |
| Number of Subjects Who Discontinue Due to AEs | Weeks 0-6 | — |
| Percentage of Subjects Who Discontinue Due to AEs | Weeks 0-6 | — |
| Number of Subjects Experiencing Local Nasal AEs | Weeks 0-6 | 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. |
| Percentage of Subjects Experiencing Local Nasal AEs | Weeks 0-6 | 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. |
| Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline | Baseline | — |
| Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment | Weeks 0-6 | — |
| Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline | Baseline | — |
| Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment | Weeks 0-6 | — |
| Baseline Daily Subject-reported AM Reflective TNSS | Baseline | 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. |
| Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment | Weeks 0-6 | 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. |
| Baseline Daily Subject-reported PM Reflective TNSS | Baseline | 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. |
| Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment | Weeks 0-6 | 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. |
| Baseline Daily Subject-reported AM Instantaneous TNSS | Baseline | 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. |
| Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment | Weeks 0-6 | 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. |
| Baseline Daily Subject-reported AM and PM Reflective TNSS | Baseline | 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. |
| 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 | Weeks 0-6 | 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. |
| Baseline Daily Subject-reported PM Instantaneous TNSS | Baseline | 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. |
| Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment | Weeks 0-6 | 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. |
| Baseline Daily Subject-reported AM and PM Instantaneous TNSS | Baseline | 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. |
| Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment | Weeks 0-6 | 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. |
| Baseline Daily Subject-reported Individual AM Reflective NSS | Baseline | 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. |
| Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Weeks 0-6 | 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. |
| Baseline Daily Subject-reported Individual PM Reflective NSS | Baseline | 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. |
| Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Weeks 0-6 | 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. |
| Baseline Daily Subject-reported Individual AM and PM Reflective NSS | Baseline | 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. |
| Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Weeks 0-6 | 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. |
| Baseline Daily Subject-reported Individual AM Instantaneous NSS | Baseline | 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. |
| Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Weeks 0-6 | 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. |
| Baseline Daily Subject-reported Individual PM Instantaneous NSS | Baseline | 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. |
| Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Weeks 0-6 | 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. |
| Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS | Baseline | 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. |
| Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Weeks 0-6 | 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 to Maximal Effect Over 6 Weeks of Double-blind Treatment. | Weeks 0-6 | 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. |
| Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances. | Weeks 1-2, 2-4 | Ratio of correct advance is defined as the (number of doses actuated/number of dose reported). |
| Number of Subjects Experiencing Adverse Events (AEs) | Weeks 0-6 | — |
| Percentage of Devices With Actuation Consistency | Weeks 1-4 | Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration. |
| Number of Devices With Major Discrepancies | Week 6 | A major discrepancy is defined as a discrepancy of \>20 actuations between the dose indicator and subject self report of study medication administration. |
| Percentage of Devices With Major Discrepancies | Week 6 | A major discrepancy is defined as a discrepancy of \>20 actuations between the dose indicator and subject self report of study medication administration. |
| Number of Devices With Actuation Consistency | Weeks 1-4 | Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration. |
| Percentage of Subjects Experiencing Adverse Events (AEs) | Weeks 0-6 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg Ciclesonide HFA Nasal Aerosol 320 mcg once daily | 51 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg Ciclesonide HFA Nasal Aerosol 160 mcg once daily | 60 |
| HFA Nasal Aerosol Placebo HFA Nasal Aerosol Placebo once daily | 57 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg Ciclesonide Aqueous Nasal Spray 200 mcg once daily | 48 |
| AQ Nasal Spray Placebo AQ Nasal Spray Placebo once daily | 58 |
| Placebo HFA Plus Dexamethasone 6 mg Placebo HFA plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of the placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses. | 18 |
| Placebo AQ Plus Dexamethasone 6 mg Placebo AQ plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of these placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses. | 18 |
| Total | 310 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Other | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 3 | 2 | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | 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 | Ciclesonide HFA Nasal Aerosol 320 Mcg | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 10 Participants | 12 Participants | 8 Participants | 9 Participants | 2 Participants | 3 Participants | 4 Participants | 48 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 43 Participants | 40 Participants | 48 Participants | 16 Participants | 15 Participants | 47 Participants | 259 Participants |
| Age Continuous | 34.5 years STANDARD_DEVIATION 13.42 | 33.0 years STANDARD_DEVIATION 15.69 | 32.3 years STANDARD_DEVIATION 12.53 | 35.5 years STANDARD_DEVIATION 14.55 | 35.4 years STANDARD_DEVIATION 12.94 | 34.0 years STANDARD_DEVIATION 134.41 | 35.8 years STANDARD_DEVIATION 13.62 | 34.26 years STANDARD_DEVIATION 14.01 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 6 Participants | 11 Participants | 10 Participants | 3 Participants | 3 Participants | 11 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 51 Participants | 37 Participants | 48 Participants | 15 Participants | 15 Participants | 40 Participants | 250 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, customized American Indian or Alaska Native | 0 particpants | 0 particpants | 1 particpants | 1 particpants | 0 particpants | 0 particpants | 0 particpants | 2 particpants |
| Race/Ethnicity, customized Asian | 5 particpants | 0 particpants | 0 particpants | 0 particpants | 0 particpants | 0 particpants | 1 particpants | 6 particpants |
| Race/Ethnicity, customized Black or African American | 4 particpants | 5 particpants | 4 particpants | 5 particpants | 2 particpants | 1 particpants | 1 particpants | 22 particpants |
| Race/Ethnicity, customized Multiple | 0 particpants | 0 particpants | 1 particpants | 0 particpants | 1 particpants | 1 particpants | 0 particpants | 3 particpants |
| Race/Ethnicity, customized Native Hawaiian or Other Pacific Islander | 0 particpants | 0 particpants | 0 particpants | 0 particpants | 0 particpants | 0 particpants | 0 particpants | 0 particpants |
| Race/Ethnicity, customized Other | 0 particpants | 0 particpants | 0 particpants | 0 particpants | 0 particpants | 1 particpants | 0 particpants | 1 particpants |
| Race/Ethnicity, customized White/Caucasian | 51 particpants | 52 particpants | 42 particpants | 52 particpants | 15 particpants | 15 particpants | 49 particpants | 276 particpants |
| Sex: Female, Male Female | 37 Participants | 37 Participants | 30 Participants | 33 Participants | 6 Participants | 12 Participants | 32 Participants | 187 Participants |
| Sex: Female, Male Male | 23 Participants | 20 Participants | 18 Participants | 25 Participants | 12 Participants | 6 Participants | 19 Participants | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 24 / 51 | 22 / 60 | 16 / 57 | 25 / 48 | 22 / 58 |
| serious Total, serious adverse events | 0 / 48 | 0 / 57 | 0 / 18 | 0 / 47 | 0 / 57 |
Outcome results
Primary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline | 183.2 mcg•h/dL | Standard Deviation 61.9 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline | 171.7 mcg•h/dL | Standard Deviation 40.1 |
| HFA Nasal Aerosol Placebo | Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline | 173.1 mcg•h/dL | Standard Deviation 53.5 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline | 172.8 mcg•h/dL | Standard Deviation 42.5 |
| Placebo Aqueous Nasal Spray | Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline | 179.0 mcg•h/dL | Standard Deviation 37.9 |
Primary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 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 mcg•h/dL | Standard Error 5 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 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 | -2.6 mcg•h/dL | Standard Error 4.6 |
| HFA Nasal Aerosol Placebo | 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 | -5.0 mcg•h/dL | Standard Error 4.6 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | 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 | -11.4 mcg•h/dL | Standard Error 5.7 |
| 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 | -1.0 mcg•h/dL | Standard Error 5.2 |
Comparison: Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.p-value: >0.0595% CI: [-13.9, 13]ANCOVA
Comparison: Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.p-value: 0.02595% CI: [-15.1, 10.2]ANCOVA
Comparison: Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.p-value: >0.0595% CI: [-4.7, 25.5]ANCOVA
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported AM and PM Instantaneous TNSS | 6.87 units on a scale | Standard Deviation 2.84 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported AM and PM Instantaneous TNSS | 7.62 units on a scale | Standard Deviation 2.29 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported AM and PM Instantaneous TNSS | 7.26 units on a scale | Standard Deviation 2.67 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported AM and PM Instantaneous TNSS | 7.30 units on a scale | Standard Deviation 2.52 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported AM and PM Instantaneous TNSS | 7.33 units on a scale | Standard Deviation 2.74 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported AM and PM Reflective TNSS | 7.68 units on a scale | Standard Deviation 2.33 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported AM and PM Reflective TNSS | 8.20 units on a scale | Standard Deviation 2.14 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported AM and PM Reflective TNSS | 7.82 units on a scale | Standard Deviation 2.45 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported AM and PM Reflective TNSS | 8.01 units on a scale | Standard Deviation 2.52 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported AM and PM Reflective TNSS | 8.01 units on a scale | Standard Deviation 2.49 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported AM Instantaneous TNSS | 6.91 units on a scale | Standard Deviation 2.68 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported AM Instantaneous TNSS | 7.63 units on a scale | Standard Deviation 2.35 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported AM Instantaneous TNSS | 7.37 units on a scale | Standard Deviation 2.68 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported AM Instantaneous TNSS | 7.24 units on a scale | Standard Deviation 2.43 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported AM Instantaneous TNSS | 7.19 units on a scale | Standard Deviation 2.84 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported AM Reflective TNSS | 7.55 units on a scale | Standard Deviation 2.39 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported AM Reflective TNSS | 8.03 units on a scale | Standard Deviation 2.27 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported AM Reflective TNSS | 7.81 units on a scale | Standard Deviation 2.47 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported AM Reflective TNSS | 7.91 units on a scale | Standard Deviation 2.5 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported AM Reflective TNSS | 7.84 units on a scale | Standard Deviation 2.58 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS | Baseline Nasal Sneezing | 1.33 units on a scale | Standard Deviation 0.83 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS | Baseline Runny Nose | 1.81 units on a scale | Standard Deviation 0.83 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS | Baseline Nasal Itching | 1.61 units on a scale | Standard Deviation 0.86 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS | Baseline Nasal Congestion | 2.13 units on a scale | Standard Deviation 0.72 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS | Baseline Nasal Sneezing | 1.47 units on a scale | Standard Deviation 0.89 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS | Baseline Nasal Congestion | 2.23 units on a scale | Standard Deviation 0.55 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS | Baseline Runny Nose | 2.05 units on a scale | Standard Deviation 0.67 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS | Baseline Nasal Itching | 1.87 units on a scale | Standard Deviation 0.75 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS | Baseline Nasal Congestion | 2.19 units on a scale | Standard Deviation 0.62 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS | Baseline Runny Nose | 2.00 units on a scale | Standard Deviation 0.72 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS | Baseline Nasal Itching | 1.70 units on a scale | Standard Deviation 0.84 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS | Baseline Nasal Sneezing | 1.37 units on a scale | Standard Deviation 0.91 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS | Baseline Nasal Sneezing | 1.22 units on a scale | Standard Deviation 0.83 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS | Baseline Runny Nose | 2.10 units on a scale | Standard Deviation 0.69 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS | Baseline Nasal Congestion | 2.20 units on a scale | Standard Deviation 0.68 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS | Baseline Nasal Itching | 1.78 units on a scale | Standard Deviation 0.87 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS | Baseline Nasal Congestion | 2.16 units on a scale | Standard Deviation 0.63 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS | Baseline Nasal Itching | 1.80 units on a scale | Standard Deviation 0.89 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS | Baseline Runny Nose | 1.98 units on a scale | Standard Deviation 0.8 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS | Baseline Nasal Sneezing | 1.38 units on a scale | Standard Deviation 0.95 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual AM and PM Reflective NSS | Baseline Nasal Sneezing | 1.69 units on a scale | Standard Deviation 0.73 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual AM and PM Reflective NSS | Baseline Runny Nose | 2.01 units on a scale | Standard Deviation 0.65 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual AM and PM Reflective NSS | Baseline Nasal Itching | 1.73 units on a scale | Standard Deviation 0.83 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual AM and PM Reflective NSS | Baseline Nasal Congestion | 2.26 units on a scale | Standard Deviation 0.63 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual AM and PM Reflective NSS | Baseline Nasal Sneezing | 1.76 units on a scale | Standard Deviation 0.79 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual AM and PM Reflective NSS | Baseline Nasal Congestion | 2.31 units on a scale | Standard Deviation 0.53 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual AM and PM Reflective NSS | Baseline Runny Nose | 2.18 units on a scale | Standard Deviation 0.59 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual AM and PM Reflective NSS | Baseline Nasal Itching | 1.95 units on a scale | Standard Deviation 0.73 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual AM and PM Reflective NSS | Baseline Nasal Congestion | 2.26 units on a scale | Standard Deviation 0.62 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual AM and PM Reflective NSS | Baseline Runny Nose | 2.13 units on a scale | Standard Deviation 0.69 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual AM and PM Reflective NSS | Baseline Nasal Itching | 1.82 units on a scale | Standard Deviation 0.8 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual AM and PM Reflective NSS | Baseline Nasal Sneezing | 1.62 units on a scale | Standard Deviation 0.83 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual AM and PM Reflective NSS | Baseline Nasal Sneezing | 1.51 units on a scale | Standard Deviation 0.78 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual AM and PM Reflective NSS | Baseline Runny Nose | 2.29 units on a scale | Standard Deviation 0.7 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual AM and PM Reflective NSS | Baseline Nasal Congestion | 2.33 units on a scale | Standard Deviation 0.67 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual AM and PM Reflective NSS | Baseline Nasal Itching | 1.89 units on a scale | Standard Deviation 0.85 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual AM and PM Reflective NSS | Baseline Nasal Congestion | 2.27 units on a scale | Standard Deviation 0.61 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual AM and PM Reflective NSS | Baseline Nasal Itching | 1.96 units on a scale | Standard Deviation 0.79 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual AM and PM Reflective NSS | Baseline Runny Nose | 2.11 units on a scale | Standard Deviation 0.72 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual AM and PM Reflective NSS | Baseline Nasal Sneezing | 1.66 units on a scale | Standard Deviation 0.87 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual AM Instantaneous NSS | Baseline Nasal Sneezing | 1.24 units on a scale | Standard Deviation 0.82 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual AM Instantaneous NSS | Baseline Runny Nose | 1.83 units on a scale | Standard Deviation 0.84 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual AM Instantaneous NSS | Baseline Nasal Itching | 1.61 units on a scale | Standard Deviation 0.86 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual AM Instantaneous NSS | Baseline Nasal Congestion | 2.24 units on a scale | Standard Deviation 0.67 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual AM Instantaneous NSS | Baseline Nasal Sneezing | 1.43 units on a scale | Standard Deviation 0.96 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual AM Instantaneous NSS | Baseline Nasal Congestion | 2.27 units on a scale | Standard Deviation 0.58 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual AM Instantaneous NSS | Baseline Runny Nose | 2.08 units on a scale | Standard Deviation 0.66 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual AM Instantaneous NSS | Baseline Nasal Itching | 1.85 units on a scale | Standard Deviation 0.75 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual AM Instantaneous NSS | Baseline Nasal Congestion | 2.27 units on a scale | Standard Deviation 0.6 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual AM Instantaneous NSS | Baseline Runny Nose | 2.01 units on a scale | Standard Deviation 0.74 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual AM Instantaneous NSS | Baseline Nasal Itching | 1.76 units on a scale | Standard Deviation 0.89 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual AM Instantaneous NSS | Baseline Nasal Sneezing | 1.34 units on a scale | Standard Deviation 0.94 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual AM Instantaneous NSS | Baseline Nasal Sneezing | 1.15 units on a scale | Standard Deviation 0.85 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual AM Instantaneous NSS | Baseline Runny Nose | 2.08 units on a scale | Standard Deviation 0.68 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual AM Instantaneous NSS | Baseline Nasal Congestion | 2.25 units on a scale | Standard Deviation 0.66 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual AM Instantaneous NSS | Baseline Nasal Itching | 1.76 units on a scale | Standard Deviation 0.89 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual AM Instantaneous NSS | Baseline Nasal Congestion | 2.20 units on a scale | Standard Deviation 0.66 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual AM Instantaneous NSS | Baseline Nasal Itching | 1.76 units on a scale | Standard Deviation 0.91 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual AM Instantaneous NSS | Baseline Runny Nose | 1.93 units on a scale | Standard Deviation 0.89 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual AM Instantaneous NSS | Baseline Nasal Sneezing | 1.30 units on a scale | Standard Deviation 1.02 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual AM Reflective NSS | Baseline Nasal Sneezing | 1.56 units on a scale | Standard Deviation 0.83 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual AM Reflective NSS | Baseline Runny Nose | 1.99 units on a scale | Standard Deviation 0.68 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual AM Reflective NSS | Baseline Nasal Itching | 1.71 units on a scale | Standard Deviation 0.85 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual AM Reflective NSS | Baseline Nasal Congestion | 2.30 units on a scale | Standard Deviation 0.59 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual AM Reflective NSS | Baseline Nasal Sneezing | 1.65 units on a scale | Standard Deviation 0.88 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual AM Reflective NSS | Baseline Nasal Congestion | 2.32 units on a scale | Standard Deviation 0.57 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual AM Reflective NSS | Baseline Runny Nose | 2.16 units on a scale | Standard Deviation 0.63 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual AM Reflective NSS | Baseline Nasal Itching | 1.89 units on a scale | Standard Deviation 0.75 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual AM Reflective NSS | Baseline Nasal Congestion | 2.29 units on a scale | Standard Deviation 0.6 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual AM Reflective NSS | Baseline Runny Nose | 2.15 units on a scale | Standard Deviation 0.7 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual AM Reflective NSS | Baseline Nasal Itching | 1.83 units on a scale | Standard Deviation 0.83 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual AM Reflective NSS | Baseline Nasal Sneezing | 1.54 units on a scale | Standard Deviation 0.89 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual AM Reflective NSS | Baseline Nasal Sneezing | 1.42 units on a scale | Standard Deviation 0.81 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual AM Reflective NSS | Baseline Runny Nose | 2.27 units on a scale | Standard Deviation 0.71 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual AM Reflective NSS | Baseline Nasal Congestion | 2.36 units on a scale | Standard Deviation 0.66 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual AM Reflective NSS | Baseline Nasal Itching | 1.85 units on a scale | Standard Deviation 0.85 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual AM Reflective NSS | Baseline Nasal Congestion | 2.29 units on a scale | Standard Deviation 0.62 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual AM Reflective NSS | Baseline Nasal Itching | 1.92 units on a scale | Standard Deviation 0.83 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual AM Reflective NSS | Baseline Runny Nose | 2.06 units on a scale | Standard Deviation 0.76 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual AM Reflective NSS | Baseline Nasal Sneezing | 1.57 units on a scale | Standard Deviation 0.93 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual PM Instantaneous NSS | Baseline Nasal Itching | 1.60 units on a scale | Standard Deviation 0.9 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual PM Instantaneous NSS | Baseline Nasal Sneezing | 1.42 units on a scale | Standard Deviation 0.89 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual PM Instantaneous NSS | Baseline Runny Nose | 1.80 units on a scale | Standard Deviation 0.85 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual PM Instantaneous NSS | Baseline Nasal Congestion | 2.02 units on a scale | Standard Deviation 0.82 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual PM Instantaneous NSS | Baseline Runny Nose | 2.03 units on a scale | Standard Deviation 0.73 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual PM Instantaneous NSS | Baseline Nasal Sneezing | 1.51 units on a scale | Standard Deviation 0.86 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual PM Instantaneous NSS | Baseline Nasal Itching | 1.88 units on a scale | Standard Deviation 0.78 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual PM Instantaneous NSS | Baseline Nasal Congestion | 2.19 units on a scale | Standard Deviation 0.59 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual PM Instantaneous NSS | Baseline Nasal Sneezing | 1.40 units on a scale | Standard Deviation 0.93 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual PM Instantaneous NSS | Baseline Nasal Congestion | 2.11 units on a scale | Standard Deviation 0.68 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual PM Instantaneous NSS | Baseline Runny Nose | 1.98 units on a scale | Standard Deviation 0.72 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual PM Instantaneous NSS | Baseline Nasal Itching | 1.64 units on a scale | Standard Deviation 0.84 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual PM Instantaneous NSS | Baseline Nasal Sneezing | 1.30 units on a scale | Standard Deviation 0.85 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual PM Instantaneous NSS | Baseline Nasal Congestion | 2.16 units on a scale | Standard Deviation 0.76 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual PM Instantaneous NSS | Baseline Nasal Itching | 1.79 units on a scale | Standard Deviation 0.87 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual PM Instantaneous NSS | Baseline Runny Nose | 2.13 units on a scale | Standard Deviation 0.75 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual PM Instantaneous NSS | Baseline Nasal Congestion | 2.12 units on a scale | Standard Deviation 0.65 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual PM Instantaneous NSS | Baseline Nasal Sneezing | 1.47 units on a scale | Standard Deviation 0.92 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual PM Instantaneous NSS | Baseline Runny Nose | 2.01 units on a scale | Standard Deviation 0.76 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual PM Instantaneous NSS | Baseline Nasal Itching | 1.84 units on a scale | Standard Deviation 0.91 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual PM Reflective NSS | Baseline Nasal Sneezing | 1.82 units on a scale | Standard Deviation 0.71 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual PM Reflective NSS | Baseline Runny Nose | 2.03 units on a scale | Standard Deviation 0.66 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual PM Reflective NSS | Baseline Nasal Itching | 1.75 units on a scale | Standard Deviation 0.83 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported Individual PM Reflective NSS | Baseline Nasal Congestion | 2.23 units on a scale | Standard Deviation 0.72 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual PM Reflective NSS | Baseline Nasal Sneezing | 1.87 units on a scale | Standard Deviation 0.76 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual PM Reflective NSS | Baseline Nasal Congestion | 2.30 units on a scale | Standard Deviation 0.54 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual PM Reflective NSS | Baseline Runny Nose | 2.20 units on a scale | Standard Deviation 0.58 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported Individual PM Reflective NSS | Baseline Nasal Itching | 2.02 units on a scale | Standard Deviation 0.75 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual PM Reflective NSS | Baseline Nasal Congestion | 2.23 units on a scale | Standard Deviation 0.67 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual PM Reflective NSS | Baseline Runny Nose | 2.11 units on a scale | Standard Deviation 0.71 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual PM Reflective NSS | Baseline Nasal Itching | 1.80 units on a scale | Standard Deviation 0.82 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported Individual PM Reflective NSS | Baseline Nasal Sneezing | 1.69 units on a scale | Standard Deviation 0.81 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual PM Reflective NSS | Baseline Nasal Sneezing | 1.59 units on a scale | Standard Deviation 0.83 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual PM Reflective NSS | Baseline Runny Nose | 2.30 units on a scale | Standard Deviation 0.74 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual PM Reflective NSS | Baseline Nasal Congestion | 2.31 units on a scale | Standard Deviation 0.73 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported Individual PM Reflective NSS | Baseline Nasal Itching | 1.93 units on a scale | Standard Deviation 0.87 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual PM Reflective NSS | Baseline Nasal Congestion | 2.25 units on a scale | Standard Deviation 0.63 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual PM Reflective NSS | Baseline Nasal Itching | 2.00 units on a scale | Standard Deviation 0.78 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual PM Reflective NSS | Baseline Runny Nose | 2.16 units on a scale | Standard Deviation 0.73 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported Individual PM Reflective NSS | Baseline Nasal Sneezing | 1.74 units on a scale | Standard Deviation 0.87 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported PM Instantaneous TNSS | 6.84 units on a scale | Standard Deviation 3.09 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported PM Instantaneous TNSS | 7.60 units on a scale | Standard Deviation 2.37 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported PM Instantaneous TNSS | 7.13 units on a scale | Standard Deviation 2.75 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported PM Instantaneous TNSS | 7.38 units on a scale | Standard Deviation 2.68 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported PM Instantaneous TNSS | 7.44 units on a scale | Standard Deviation 2.74 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Baseline Daily Subject-reported PM Reflective TNSS | 7.82 units on a scale | Standard Deviation 2.4 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Baseline Daily Subject-reported PM Reflective TNSS | 8.39 units on a scale | Standard Deviation 2.11 |
| HFA Nasal Aerosol Placebo | Baseline Daily Subject-reported PM Reflective TNSS | 7.83 units on a scale | Standard Deviation 2.52 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Baseline Daily Subject-reported PM Reflective TNSS | 8.13 units on a scale | Standard Deviation 2.66 |
| Placebo Aqueous Nasal Spray | Baseline Daily Subject-reported PM Reflective TNSS | 8.16 units on a scale | Standard Deviation 2.51 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -1.45 units on a scale | Standard Error 0.27 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -1.67 units on a scale | Standard Error 0.25 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -0.19 units on a scale | Standard Error 0.25 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -1.15 units on a scale | Standard Error 0.29 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -0.75 units on a scale | Standard Error 0.27 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 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 units on a scale | Standard Error 0.29 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 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 | -1.82 units on a scale | Standard Error 0.27 |
| HFA Nasal Aerosol 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 | -0.33 units on a scale | Standard Error 0.27 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | 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 | -1.16 units on a scale | Standard Error 0.29 |
| Placebo Aqueous Nasal Spray | 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 | -1.06 units on a scale | Standard Error 0.27 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -1.52 units on a scale | Standard Error 0.27 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -1.62 units on a scale | Standard Error 0.25 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -0.26 units on a scale | Standard Error 0.25 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -1.23 units on a scale | Standard Error 0.29 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -0.60 units on a scale | Standard Error 0.26 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -1.80 units on a scale | Standard Error 0.29 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -1.75 units on a scale | Standard Error 0.26 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -0.35 units on a scale | Standard Error 0.27 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -1.18 units on a scale | Standard Error 0.3 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -0.91 units on a scale | Standard Error 0.28 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Sneezing | -0.32 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Runny Nose | -0.42 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Itching | -0.35 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Congestion | -0.37 units on a scale | Standard Error 0.07 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Sneezing | -0.37 units on a scale | Standard Error 0.07 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Congestion | -0.39 units on a scale | Standard Error 0.06 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Runny Nose | -0.47 units on a scale | Standard Error 0.07 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Itching | -0.42 units on a scale | Standard Error 0.07 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Congestion | -0.01 units on a scale | Standard Error 0.06 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Runny Nose | -0.10 units on a scale | Standard Error 0.07 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Itching | -0.01 units on a scale | Standard Error 0.07 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Sneezing | -0.06 units on a scale | Standard Error 0.07 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Sneezing | -0.23 units on a scale | Standard Error 0.08 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Runny Nose | -0.35 units on a scale | Standard Error 0.09 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Congestion | -0.17 units on a scale | Standard Error 0.08 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Itching | -0.37 units on a scale | Standard Error 0.09 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Congestion | -0.09 units on a scale | Standard Error 0.08 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Itching | -0.20 units on a scale | Standard Error 0.08 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Runny Nose | -0.27 units on a scale | Standard Error 0.09 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Sneezing | -0.20 units on a scale | Standard Error 0.07 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Sneezing | -0.43 units on a scale | Standard Error 0.09 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Runny Nose | -0.50 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Itching | -0.39 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Congestion | -0.47 units on a scale | Standard Error 0.07 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Sneezing | -0.45 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Congestion | -0.43 units on a scale | Standard Error 0.07 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Runny Nose | -0.50 units on a scale | Standard Error 0.07 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Itching | -0.43 units on a scale | Standard Error 0.08 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Congestion | -0.04 units on a scale | Standard Error 0.07 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Runny Nose | -0.13 units on a scale | Standard Error 0.08 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Itching | -0.05 units on a scale | Standard Error 0.08 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Sneezing | -0.11 units on a scale | Standard Error 0.08 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Sneezing | -0.25 units on a scale | Standard Error 0.08 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Runny Nose | -0.37 units on a scale | Standard Error 0.09 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Congestion | -0.20 units on a scale | Standard Error 0.09 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Itching | -0.32 units on a scale | Standard Error 0.09 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Congestion | -0.17 units on a scale | Standard Error 0.08 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Itching | -0.30 units on a scale | Standard Error 0.08 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Runny Nose | -0.33 units on a scale | Standard Error 0.08 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Sneezing | -0.26 units on a scale | Standard Error 0.07 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Sneezing | -0.32 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Runny Nose | -0.43 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Itching | -0.38 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Congestion | -0.41 units on a scale | Standard Error 0.07 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Sneezing | -0.37 units on a scale | Standard Error 0.07 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Congestion | -0.37 units on a scale | Standard Error 0.07 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Runny Nose | -0.47 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Itching | -0.40 units on a scale | Standard Error 0.07 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Congestion | -0.05 units on a scale | Standard Error 0.07 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Runny Nose | -0.12 units on a scale | Standard Error 0.08 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Itching | -0.03 units on a scale | Standard Error 0.08 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Sneezing | -0.06 units on a scale | Standard Error 0.08 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Sneezing | -0.24 units on a scale | Standard Error 0.08 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Runny Nose | -0.36 units on a scale | Standard Error 0.1 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Congestion | -0.20 units on a scale | Standard Error 0.08 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Itching | -0.40 units on a scale | Standard Error 0.09 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Congestion | -0.06 units on a scale | Standard Error 0.07 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Itching | -0.14 units on a scale | Standard Error 0.08 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Runny Nose | -0.23 units on a scale | Standard Error 0.09 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Sneezing | -0.17 units on a scale | Standard Error 0.07 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Itching | -0.40 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Sneezing | -0.41 units on a scale | Standard Error 0.09 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Runny Nose | -0.50 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Congestion | -0.49 units on a scale | Standard Error 0.07 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Runny Nose | -0.50 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Sneezing | -0.41 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Itching | -0.40 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Congestion | -0.42 units on a scale | Standard Error 0.07 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Sneezing | -0.09 units on a scale | Standard Error 0.08 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Congestion | -0.05 units on a scale | Standard Error 0.07 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Runny Nose | -0.17 units on a scale | Standard Error 0.08 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Itching | -0.05 units on a scale | Standard Error 0.08 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Sneezing | -0.28 units on a scale | Standard Error 0.08 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Congestion | -0.20 units on a scale | Standard Error 0.09 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Itching | -0.33 units on a scale | Standard Error 0.09 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Runny Nose | -0.36 units on a scale | Standard Error 0.1 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Congestion | -0.13 units on a scale | Standard Error 0.08 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Sneezing | -0.25 units on a scale | Standard Error 0.08 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Runny Nose | -0.29 units on a scale | Standard Error 0.09 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Itching | -0.25 units on a scale | Standard Error 0.08 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Sneezing | -0.33 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Runny Nose | -0.41 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Itching | -0.32 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Congestion | -0.34 units on a scale | Standard Error 0.07 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Sneezing | -0.37 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Congestion | -0.39 units on a scale | Standard Error 0.07 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Runny Nose | -0.45 units on a scale | Standard Error 0.07 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Itching | -0.44 units on a scale | Standard Error 0.07 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Congestion | 0.02 units on a scale | Standard Error 0.07 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Runny Nose | -0.08 units on a scale | Standard Error 0.08 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Itching | 0.02 units on a scale | Standard Error 0.07 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Sneezing | -0.07 units on a scale | Standard Error 0.08 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Sneezing | -0.24 units on a scale | Standard Error 0.08 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Runny Nose | -0.33 units on a scale | Standard Error 0.1 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Congestion | -0.15 units on a scale | Standard Error 0.09 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Itching | -0.35 units on a scale | Standard Error 0.09 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Congestion | -0.12 units on a scale | Standard Error 0.08 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Itching | -0.25 units on a scale | Standard Error 0.08 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Runny Nose | -0.30 units on a scale | Standard Error 0.09 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment | Nasal Sneezing | -0.22 units on a scale | Standard Error 0.08 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Sneezing | -0.45 units on a scale | Standard Error 0.09 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Runny Nose | -0.49 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Itching | -0.38 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Congestion | -0.44 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Sneezing | -0.48 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Congestion | -0.44 units on a scale | Standard Error 0.07 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Runny Nose | -0.48 units on a scale | Standard Error 0.08 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Itching | -0.46 units on a scale | Standard Error 0.08 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Congestion | -0.04 units on a scale | Standard Error 0.07 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Runny Nose | -0.09 units on a scale | Standard Error 0.08 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Itching | -0.05 units on a scale | Standard Error 0.08 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Sneezing | -0.13 units on a scale | Standard Error 0.08 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Sneezing | -0.23 units on a scale | Standard Error 0.08 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Runny Nose | -0.37 units on a scale | Standard Error 0.09 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Congestion | -0.20 units on a scale | Standard Error 0.09 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Itching | -0.32 units on a scale | Standard Error 0.09 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Congestion | -0.21 units on a scale | Standard Error 0.08 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Itching | -0.34 units on a scale | Standard Error 0.08 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Runny Nose | -0.37 units on a scale | Standard Error 0.08 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period | Nasal Sneezing | -0.27 units on a scale | Standard Error 0.08 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -1.39 units on a scale | Standard Error 0.28 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -1.67 units on a scale | Standard Error 0.26 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -0.10 units on a scale | Standard Error 0.26 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -1.09 units on a scale | Standard Error 0.3 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -0.88 units on a scale | Standard Error 0.28 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -1.77 units on a scale | Standard Error 0.3 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -1.88 units on a scale | Standard Error 0.28 |
| HFA Nasal Aerosol Placebo | Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -0.31 units on a scale | Standard Error 0.28 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -1.14 units on a scale | Standard Error 0.29 |
| Placebo Aqueous Nasal Spray | Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment | -1.19 units on a scale | Standard Error 0.26 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment | -1.0 mcg•h/dL | Standard Error 3.2 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment | -1.3 mcg•h/dL | Standard Error 3 |
| HFA Nasal Aerosol Placebo | Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment | 0.5 mcg•h/dL | Standard Error 3 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment | -5.8 mcg•h/dL | Standard Error 3 |
| Placebo Aqueous Nasal Spray | Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment | -2.9 mcg•h/dL | Standard Error 2.7 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment | -3.9 mcg•h/dL | Standard Error 2.9 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment | -2.0 mcg•h/dL | Standard Error 2.7 |
| HFA Nasal Aerosol Placebo | Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment | -5.9 mcg•h/dL | Standard Error 2.7 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment | -6.1 mcg•h/dL | Standard Error 3.7 |
| Placebo Aqueous Nasal Spray | Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment | 2.2 mcg•h/dL | Standard Error 3.4 |
Secondary
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
Population: Intent to Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Number of Devices With Actuation Consistency | 42 Devices |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Number of Devices With Actuation Consistency | 48 Devices |
| HFA Nasal Aerosol Placebo | Number of Devices With Actuation Consistency | 68 Devices |
Secondary
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
Population: Intent to Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Number of Devices With Major Discrepancies | 0 Devices |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Number of Devices With Major Discrepancies | 2 Devices |
| HFA Nasal Aerosol Placebo | Number of Devices With Major Discrepancies | 1 Devices |
Secondary
Number of Subjects Experiencing Adverse Events (AEs)
Time frame: Weeks 0-6
Population: Intent to Treat Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Number of Subjects Experiencing Adverse Events (AEs) | 23 participants |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Number of Subjects Experiencing Adverse Events (AEs) | 17 participants |
| HFA Nasal Aerosol Placebo | Number of Subjects Experiencing Adverse Events (AEs) | 23 participants |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Number of Subjects Experiencing Adverse Events (AEs) | 19 participants |
| Placebo Aqueous Nasal Spray | Number of Subjects Experiencing Adverse Events (AEs) | 29 participants |
Secondary
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
Population: Intent to Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Number of Subjects Experiencing Local Nasal AEs | 21 participants |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Number of Subjects Experiencing Local Nasal AEs | 11 participants |
| HFA Nasal Aerosol Placebo | Number of Subjects Experiencing Local Nasal AEs | 8 participants |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Number of Subjects Experiencing Local Nasal AEs | 16 participants |
| Placebo Aqueous Nasal Spray | Number of Subjects Experiencing Local Nasal AEs | 11 participants |
| Placebo HFA Plus 6 mg Dexamethasone | Number of Subjects Experiencing Local Nasal AEs | 5 participants |
| Placebo AQ Plus 6 mg Dexamethasone | Number of Subjects Experiencing Local Nasal AEs | 1 participants |
Secondary
Number of Subjects Experiencing Serious Adverse Events (SAEs).
Time frame: Weeks 0-6
Population: Intent to Treat Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Number of Subjects Experiencing Serious Adverse Events (SAEs). | 0 participants |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Number of Subjects Experiencing Serious Adverse Events (SAEs). | 0 participants |
| HFA Nasal Aerosol Placebo | Number of Subjects Experiencing Serious Adverse Events (SAEs). | 0 participants |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Number of Subjects Experiencing Serious Adverse Events (SAEs). | 0 participants |
| Placebo Aqueous Nasal Spray | Number of Subjects Experiencing Serious Adverse Events (SAEs). | 0 participants |
Secondary
Number of Subjects Who Discontinue Due to AEs
Time frame: Weeks 0-6
Population: Intent to Treat Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Number of Subjects Who Discontinue Due to AEs | 0 participants |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Number of Subjects Who Discontinue Due to AEs | 0 participants |
| HFA Nasal Aerosol Placebo | Number of Subjects Who Discontinue Due to AEs | 0 participants |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Number of Subjects Who Discontinue Due to AEs | 1 participants |
| Placebo Aqueous Nasal Spray | Number of Subjects Who Discontinue Due to AEs | 0 participants |
Secondary
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
Population: Intent to Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Percentage of Devices With Actuation Consistency | 91.3 percentage of devices |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Percentage of Devices With Actuation Consistency | 92.3 percentage of devices |
| HFA Nasal Aerosol Placebo | Percentage of Devices With Actuation Consistency | 95.8 percentage of devices |
Secondary
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
Population: Intent to Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Percentage of Devices With Major Discrepancies | 0 percentage of devices |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Percentage of Devices With Major Discrepancies | 3.8 percentage of devices |
| HFA Nasal Aerosol Placebo | Percentage of Devices With Major Discrepancies | 1.4 percentage of devices |
Secondary
Percentage of Subjects Experiencing Adverse Events (AEs)
Time frame: Weeks 0-6
Population: Intent to Treat Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Percentage of Subjects Experiencing Adverse Events (AEs) | 45.1 percentage of subjects |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Percentage of Subjects Experiencing Adverse Events (AEs) | 28.3 percentage of subjects |
| HFA Nasal Aerosol Placebo | Percentage of Subjects Experiencing Adverse Events (AEs) | 30.7 percentage of subjects |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Percentage of Subjects Experiencing Adverse Events (AEs) | 39.6 percentage of subjects |
| Placebo Aqueous Nasal Spray | Percentage of Subjects Experiencing Adverse Events (AEs) | 38.2 percentage of subjects |
Secondary
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
Population: Intent to Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Percentage of Subjects Experiencing Local Nasal AEs | 41.2 percentage of subjects |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Percentage of Subjects Experiencing Local Nasal AEs | 18.3 percentage of subjects |
| HFA Nasal Aerosol Placebo | Percentage of Subjects Experiencing Local Nasal AEs | 14.0 percentage of subjects |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Percentage of Subjects Experiencing Local Nasal AEs | 33.3 percentage of subjects |
| Placebo Aqueous Nasal Spray | Percentage of Subjects Experiencing Local Nasal AEs | 19.0 percentage of subjects |
| Placebo HFA Plus 6 mg Dexamethasone | Percentage of Subjects Experiencing Local Nasal AEs | 27.8 percentage of subjects |
| Placebo AQ Plus 6 mg Dexamethasone | Percentage of Subjects Experiencing Local Nasal AEs | 5.6 percentage of subjects |
Secondary
Percentage of Subjects Experiencing Serious Adverse Events (SAEs).
Time frame: Weeks 0-6
Population: Intent to Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Percentage of Subjects Experiencing Serious Adverse Events (SAEs). | 0 percentage of subjects |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Percentage of Subjects Experiencing Serious Adverse Events (SAEs). | 0 percentage of subjects |
| HFA Nasal Aerosol Placebo | Percentage of Subjects Experiencing Serious Adverse Events (SAEs). | 0 percentage of subjects |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Percentage of Subjects Experiencing Serious Adverse Events (SAEs). | 0 percentage of subjects |
| Placebo Aqueous Nasal Spray | Percentage of Subjects Experiencing Serious Adverse Events (SAEs). | 0 percentage of subjects |
Secondary
Percentage of Subjects Who Discontinue Due to AEs
Time frame: Weeks 0-6
Population: Intent to Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Percentage of Subjects Who Discontinue Due to AEs | 0 percentage of subjects |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Percentage of Subjects Who Discontinue Due to AEs | 0 percentage of subjects |
| HFA Nasal Aerosol Placebo | Percentage of Subjects Who Discontinue Due to AEs | 0 percentage of subjects |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Percentage of Subjects Who Discontinue Due to AEs | 2.1 percentage of subjects |
| Placebo Aqueous Nasal Spray | Percentage of Subjects Who Discontinue Due to AEs | 0 percentage of subjects |
Secondary
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
Population: Intent to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances. | Weeks 1-2 (n=49,58,75) | 106.3 percentage of correct advances | Standard Deviation 10.8 |
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances. | Weeks 2-4 (n=46,52,71) | 105.6 percentage of correct advances | Standard Deviation 11.8 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances. | Weeks 1-2 (n=49,58,75) | 106.2 percentage of correct advances | Standard Deviation 12.1 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances. | Weeks 2-4 (n=46,52,71) | 105.9 percentage of correct advances | Standard Deviation 10.5 |
| HFA Nasal Aerosol Placebo | Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances. | Weeks 1-2 (n=49,58,75) | 105.3 percentage of correct advances | Standard Deviation 15.8 |
| HFA Nasal Aerosol Placebo | Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances. | Weeks 2-4 (n=46,52,71) | 105.8 percentage of correct advances | Standard Deviation 11.7 |
Secondary
Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline
Time frame: Baseline
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline | 99.8 mcg•h/dL | Standard Deviation 38.3 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline | 95.1 mcg•h/dL | Standard Deviation 28.5 |
| HFA Nasal Aerosol Placebo | Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline | 92.0 mcg•h/dL | Standard Deviation 31.3 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline | 91.9 mcg•h/dL | Standard Deviation 25.8 |
| Placebo Aqueous Nasal Spray | Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline | 97.2 mcg•h/dL | Standard Deviation 25 |
Secondary
Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline
Time frame: Baseline
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline | 83.4 mcg•h/dL | Standard Deviation 30.2 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline | 76.2 mcg•h/dL | Standard Deviation 24 |
| HFA Nasal Aerosol Placebo | Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline | 81.1 mcg•h/dL | Standard Deviation 28.7 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline | 80.9 mcg•h/dL | Standard Deviation 26.8 |
| Placebo Aqueous Nasal Spray | Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline | 81.8 mcg•h/dL | Standard Deviation 22.8 |
Secondary
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
Population: Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | Time to Maximal Effect Over 6 Weeks of Double-blind Treatment. | 15 Number of days |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | Time to Maximal Effect Over 6 Weeks of Double-blind Treatment. | 29 Number of days |
| HFA Nasal Aerosol Placebo | Time to Maximal Effect Over 6 Weeks of Double-blind Treatment. | 7 Number of days |