Seasonal Allergic Rhinitis
Conditions
Keywords
SAR
Brief summary
To demonstrate the efficacy of ciclesonide HFA applied as a nasal aerosol (160 μg and 80 μg) once daily compared to placebo in subjects with SAR.
Detailed description
This is a randomized, double blind, placebo controlled, parallel group, multicenter study to demonstrate the efficacy of ciclesonide HFA applied as a nasal aerosol (160 μg and 80 μg) once daily compared to placebo in subjects with SAR. 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
DRUG80 mcg Ciclesonide
80 mcg Ciclesonide HFA Inhaler once daily (one actuation per nostril)
DRUG160 mcg Ciclesonide
160 mcg Ciclesonide HFA Inhaler once daily (one actuation per nostril)
DRUGPlacebo
Placebo HFA Inhaler once daily (one actuation per nostril)
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Give written informed consent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation. * Male or female 12 years and older, as of the Screening Visit (Visit 1). * 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). * A history of SAR to Mountain Cedar for a minimum of two years immediately preceding the study Screening Visit (Visit 1). The SAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and in the Investigator's judgment (through exposure to allergen) is expected to require treatment throughout the entire study period. * A demonstrated sensitivity to Mountain Cedar known to induce SAR through a standard skin prick test administered at Visit 1 (screening). A positive test is defined as a wheal diameter at least 5 mm larger than the control wheal (normal saline) for the skin prick test. * Subject, if female 65 years of age or younger, must have a negative serum pregnancy test (performed at Visit 1) prior to randomization at Visit 2. Women of childbearing potential (excluding females at least two years postmenopausal or surgically sterile) must sign the Women of Childbearing Potential Addendum to the informed consent form. 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 and will continue its 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. * Subject or parent/guardian must possess an educational level and degree of understanding of English that enables them to communicate suitably with the Investigator and study coordinator as well as accurately complete both the AR diary and RQLQ(S).
Exclusion criteria
* Female subject who is pregnant or lactating. * History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations; recent nasal biopsy; nasal trauma; nasal ulcers or perforations; or surgery and atrophic rhinitis or rhinitis medicamentosa (all within the last 60 days prior to the Screening Visit). * Participation in any investigational drug trial within the 30 days preceding the Screening Visit (Visit 1) or planned participation in another investigational drug trial at any time during this trial. * A known hypersensitivity to any corticosteroid or any of the excipients in the formulation of ciclesonide. * History of a respiratory infection or disorder \[including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)\] within the 14 days preceding the Screening Visit (Visit 1). * History of alcohol or drug abuse (or a positive urine drug screen at Visit 1) within two years preceding the Screening Visit. * History of a positive test for HIV, hepatitis B or hepatitis C. * Plans to travel outside the study area (the known pollen area for the investigative site) for more than 24 hours during the Run in period. * Plans to travel outside the study area (the known pollen area for the investigative site) for 2 or more consecutive days between Randomization Visit (Visit 3) and the final Treatment Visit (Visit 5). * Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta agonists and any controller drugs (e.g., theophylline, leukotriene antagonists, etc.); intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists is acceptable. * Use of any prohibited concomitant medications within the prescribed (per protocol) time period prior to the Screening Visit and expected use during treatment period. * Use of antibiotic therapy for acute conditions within 14 days prior to the Screening Visit. Low doses of antibiotics taken for prophylaxis are permitted if the therapy was started prior to the Screening Visit and is expected to continue throughout the trial. * Initiation of immunotherapy during the study period or dose escalation during the study period. However, initiation of immunotherapy 90 days or more prior to the Screening Visit and use of a stable (maintenance) dose (30 days or more) may be considered for inclusion. * Previous participation in an intranasal ciclesonide HFA nasal aerosol study. * Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit. * Use of topical corticosteroids in concentrations in excess of 1% hydrocortisone or equivalent within 30 days prior to Visit 2; use of a topical hydrocortisone or equivalent in any concentration covering greater than 20% of the body surface; or presence of an underlying condition (as judged by the investigator) that can reasonably be expected to require treatment with such preparations during the course of the study. * 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 the Visit 1 and use of a stable (maintenance) dose during the study period may be considered for inclusion. * Study participation by clinical investigator site employees and/or their immediate relatives. * Study participation by more than one subject from the same household at the same time. * Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial: impaired hepatic function including alcohol-related liver disease or cirrhosis; * history of ocular disturbances e.g. 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 |
|---|---|---|
| Change From Baseline in Daily Subject-reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Averaged Over the Two-week Treatment Period. | Week 0-2 | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 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 two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Daily Subject-reported AM and PM rTOSS Averaged Over the Two-week Treatment Period in Participants With a Baseline rTOSS >= 5.0 | Week 0-2 | TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the Two Week Treatment Period | Week 0-2 | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 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 two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the Two Week Treatment Period | Week 0-2 | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 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 two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the Two Week Treatment Period | Week 0-2 | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 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 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the Two Week Treatment Period | Week 0-2 | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 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). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Change From Baseline in Daily Subject-reported AM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Week 0-2 | TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Change From Baseline in Daily Subject-reported PM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Week 0-2 | TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Change From Baseline in Daily Subject-reported AM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Week 0-2 | TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Change From Baseline in Daily Subject-reported PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Week 0-2 | TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Change From Baseline in Daily Subject Reported AM and PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Week 0-2 | TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period | Week 0-2 | 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 1. = mild 2. = moderate 3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period | Week 0-2 | 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 1. = mild 2. = moderate 3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two 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 rNSS Averaged Over the Two Week Treatment Period | Week 0-2 | 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 1. = mild 2. = moderate 3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two 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 iTNSS Averaged Over the Two-week Treatment Period. | Week 0-2 | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 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). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period | Week 0-2 | 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 1. = mild 2. = moderate 3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two 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 iNSS Averaged Over the Two Week Treatment Period | Week 0-2 | 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 1. = mild 2. = moderate 3. = severe Instantaneous NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Week 0-2 | OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Week 0-2 | OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Week 0-2 | OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Week 0-2 | OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Week 0-2 | OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Week 0-2 | OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Change From Baseline in Overall Score of the Rhinoconjunctivitis Quality of Life Questionnaire With Standard Activities (RQLQ(S)) in Participants With a Baseline Overall Score >= 3.0 | Week 0-2 | The RQLQ(S) in impaired subjects (baseline RQLQ\[S\] score ≥3.0) at baseline and end of week 2. It consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores. |
| Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Baseline and up to 36 hours | Onset of nasal improvement was defined as the first assessment at which iTNSS for active treatment demonstrated an improvement over placebo from baseline. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and 12 reflecting more severe symptoms). Instaneous measures these symptoms over the previous 10 minute time interval. |
| Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Baseline and up to 48 hours | Onset of improvement iTOSS was defined as the first assessment at which iTOSSS for active treatment demonstrated an improvement over placebo from baseline. TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. |
| Time to Maximal Effect as Measured by Change From Baseline in the Average AM and PM Reflective Total Nasal Symptoms Scores (rTNSS) | Week 0-2 | The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between Ciclesonide HFA and placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. |
| Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period | Week 0-2 | 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 1. = mild 2. = moderate 3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 80 mcg Ciclesonide 80 mcg Ciclesonide once daily | 237 |
| 160 mcg Ciclesonide 160 mcg Ciclesonide once daily | 235 |
| Placebo Placebo once daily | 235 |
| Total | 707 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 4 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Other | 5 | 5 | 8 |
| Overall Study | Protocol Violation | 2 | 4 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 6 |
Baseline characteristics
| Characteristic | Placebo | 80 mcg Ciclesonide | Total | 160 mcg Ciclesonide |
|---|---|---|---|---|
| Age, Categorical <=18 years | 12 Participants | 11 Participants | 31 Participants | 8 Participants |
| Age, Categorical >=65 years | 20 Participants | 6 Participants | 36 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 203 Participants | 220 Participants | 640 Participants | 217 Participants |
| Age, Continuous | 42.2 years STANDARD_DEVIATION 13.9 | 41.1 years STANDARD_DEVIATION 12.7 | 41.8 years STANDARD_DEVIATION 13.2 | 42.1 years STANDARD_DEVIATION 12.9 |
| Baseline individual instantaneous ocular symtom score (iOSS) in subjects with (iTOSS) ≥5.0 AM and PM Itching Eyes | 2.43 Units on scale STANDARD_DEVIATION 0.45 | 2.41 Units on scale STANDARD_DEVIATION 0.38 | 2.42 Units on scale STANDARD_DEVIATION 0.42 | 2.42 Units on scale STANDARD_DEVIATION 0.43 |
| Baseline individual instantaneous ocular symtom score (iOSS) in subjects with (iTOSS) ≥5.0 AM and PM Redness of Eyes | 2.32 Units on scale STANDARD_DEVIATION 0.51 | 2.17 Units on scale STANDARD_DEVIATION 0.54 | 2.25 Units on scale STANDARD_DEVIATION 0.51 | 2.27 Units on scale STANDARD_DEVIATION 0.49 |
| Baseline individual instantaneous ocular symtom score (iOSS) in subjects with (iTOSS) ≥5.0 AM and PM Tearing Eyes | 2.26 Units on scale STANDARD_DEVIATION 0.51 | 2.21 Units on scale STANDARD_DEVIATION 0.47 | 2.23 Units on scale STANDARD_DEVIATION 0.47 | 2.23 Units on scale STANDARD_DEVIATION 0.45 |
| Baseline individual instantaneous ocular symtom score (iOSS) in subjects with (iTOSS) ≥5.0 AM Itching Eyes | 2.48 Units on scale STANDARD_DEVIATION 0.45 | 2.44 Units on scale STANDARD_DEVIATION 0.44 | 2.45 Units on scale STANDARD_DEVIATION 0.45 | 2.44 Units on scale STANDARD_DEVIATION 0.46 |
| Baseline individual instantaneous ocular symtom score (iOSS) in subjects with (iTOSS) ≥5.0 AM Redness of Eyes | 2.36 Units on scale STANDARD_DEVIATION 0.52 | 2.22 Units on scale STANDARD_DEVIATION 0.56 | 2.30 Units on scale STANDARD_DEVIATION 0.53 | 2.32 Units on scale STANDARD_DEVIATION 0.51 |
| Baseline individual instantaneous ocular symtom score (iOSS) in subjects with (iTOSS) ≥5.0 AM Tearing Eyes | 2.33 Units on scale STANDARD_DEVIATION 0.54 | 2.25 Units on scale STANDARD_DEVIATION 0.5 | 2.28 Units on scale STANDARD_DEVIATION 0.51 | 2.27 Units on scale STANDARD_DEVIATION 0.48 |
| Baseline individual instantaneous ocular symtom score (iOSS) in subjects with (iTOSS) ≥5.0 PM Itching Eyes | 2.39 Units on scale STANDARD_DEVIATION 0.49 | 2.38 Units on scale STANDARD_DEVIATION 0.41 | 2.39 Units on scale STANDARD_DEVIATION 0.46 | 2.40 Units on scale STANDARD_DEVIATION 0.47 |
| Baseline individual instantaneous ocular symtom score (iOSS) in subjects with (iTOSS) ≥5.0 PM Redness of Eyes | 2.28 Units on scale STANDARD_DEVIATION 0.55 | 2.12 Units on scale STANDARD_DEVIATION 0.58 | 2.20 Units on scale STANDARD_DEVIATION 0.55 | 2.22 Units on scale STANDARD_DEVIATION 0.52 |
| Baseline individual instantaneous ocular symtom score (iOSS) in subjects with (iTOSS) ≥5.0 PM Tearing Eyes | 2.19 Units on scale STANDARD_DEVIATION 0.56 | 2.17 Units on scale STANDARD_DEVIATION 0.52 | 2.18 Units on scale STANDARD_DEVIATION 0.52 | 2.19 Units on scale STANDARD_DEVIATION 0.49 |
| Baseline individual reflective ocular symptom score (rOSS) in subjects with (rTOSS) ≥5.0 AM and PM Itching Eyes | 2.42 Units on a scale STANDARD_DEVIATION 0.45 | 2.48 Units on a scale STANDARD_DEVIATION 0.39 | 2.46 Units on a scale STANDARD_DEVIATION 0.42 | 2.47 Units on a scale STANDARD_DEVIATION 0.44 |
| Baseline individual reflective ocular symptom score (rOSS) in subjects with (rTOSS) ≥5.0 AM and PM Redness of Eyes | 2.27 Units on a scale STANDARD_DEVIATION 0.53 | 2.14 Units on a scale STANDARD_DEVIATION 0.56 | 2.22 Units on a scale STANDARD_DEVIATION 0.53 | 2.25 Units on a scale STANDARD_DEVIATION 0.5 |
| Baseline individual reflective ocular symptom score (rOSS) in subjects with (rTOSS) ≥5.0 AM and PM Tearing Eyes | 2.26 Units on a scale STANDARD_DEVIATION 0.49 | 2.27 Units on a scale STANDARD_DEVIATION 0.48 | 2.27 Units on a scale STANDARD_DEVIATION 0.47 | 2.29 Units on a scale STANDARD_DEVIATION 0.44 |
| Baseline individual reflective ocular symptom score (rOSS) in subjects with (rTOSS) ≥5.0 AM Itching Eyes | 2.42 Units on a scale STANDARD_DEVIATION 0.49 | 2.48 Units on a scale STANDARD_DEVIATION 0.42 | 2.45 Units on a scale STANDARD_DEVIATION 0.47 | 2.45 Units on a scale STANDARD_DEVIATION 0.5 |
| Baseline individual reflective ocular symptom score (rOSS) in subjects with (rTOSS) ≥5.0 AM Redness of Eyes | 2.25 Units on a scale STANDARD_DEVIATION 0.55 | 2.14 Units on a scale STANDARD_DEVIATION 0.59 | 2.22 Units on a scale STANDARD_DEVIATION 0.56 | 2.26 Units on a scale STANDARD_DEVIATION 0.53 |
| Baseline individual reflective ocular symptom score (rOSS) in subjects with (rTOSS) ≥5.0 AM Tearing Eyes | 2.27 Units on a scale STANDARD_DEVIATION 0.53 | 2.26 Units on a scale STANDARD_DEVIATION 0.52 | 2.27 Units on a scale STANDARD_DEVIATION 0.51 | 2.27 Units on a scale STANDARD_DEVIATION 0.48 |
| Baseline individual reflective ocular symptom score (rOSS) in subjects with (rTOSS) ≥5.0 PM Itching of Eyes | 2.42 Units on a scale STANDARD_DEVIATION 0.45 | 2.47 Units on a scale STANDARD_DEVIATION 0.4 | 2.46 Units on a scale STANDARD_DEVIATION 0.43 | 2.48 Units on a scale STANDARD_DEVIATION 0.43 |
| Baseline individual reflective ocular symptom score (rOSS) in subjects with (rTOSS) ≥5.0 PM Redness of Eyes | 2.28 Units on a scale STANDARD_DEVIATION 0.55 | 2.15 Units on a scale STANDARD_DEVIATION 0.57 | 2.22 Units on a scale STANDARD_DEVIATION 0.54 | 2.25 Units on a scale STANDARD_DEVIATION 0.5 |
| Baseline individual reflective ocular symptom score (rOSS) in subjects with (rTOSS) ≥5.0 PM Tearing Eyes | 2.26 Units on a scale STANDARD_DEVIATION 0.5 | 2.28 Units on a scale STANDARD_DEVIATION 0.5 | 2.28 Units on a scale STANDARD_DEVIATION 0.48 | 2.31 Units on a scale STANDARD_DEVIATION 0.46 |
| Baseline instantaneous nasal symptom score (iNSS) AM and PM Nasal Congestion | 2.40 Units on a scale STANDARD_DEVIATION 0.52 | 2.43 Units on a scale STANDARD_DEVIATION 0.49 | 2.44 Units on a scale STANDARD_DEVIATION 0.49 | 2.49 Units on a scale STANDARD_DEVIATION 0.47 |
| Baseline instantaneous nasal symptom score (iNSS) AM and PM Nasal Itching | 2.15 Units on a scale STANDARD_DEVIATION 0.61 | 2.21 Units on a scale STANDARD_DEVIATION 0.62 | 2.21 Units on a scale STANDARD_DEVIATION 0.61 | 2.27 Units on a scale STANDARD_DEVIATION 0.6 |
| Baseline instantaneous nasal symptom score (iNSS) AM and PM Runny Nose | 2.27 Units on a scale STANDARD_DEVIATION 0.59 | 2.29 Units on a scale STANDARD_DEVIATION 0.6 | 2.29 Units on a scale STANDARD_DEVIATION 0.6 | 2.30 Units on a scale STANDARD_DEVIATION 0.62 |
| Baseline instantaneous nasal symptom score (iNSS) AM and PM Sneezing | 1.79 Units on a scale STANDARD_DEVIATION 0.85 | 1.75 Units on a scale STANDARD_DEVIATION 0.86 | 1.80 Units on a scale STANDARD_DEVIATION 0.83 | 1.88 Units on a scale STANDARD_DEVIATION 0.78 |
| Baseline instantaneous nasal symptom score (iNSS) AM Nasal Congestion | 2.47 Units on a scale STANDARD_DEVIATION 0.52 | 2.50 Units on a scale STANDARD_DEVIATION 0.48 | 2.52 Units on a scale STANDARD_DEVIATION 0.49 | 2.58 Units on a scale STANDARD_DEVIATION 0.48 |
| Baseline instantaneous nasal symptom score (iNSS) AM Nasal Itching | 2.18 Units on a scale STANDARD_DEVIATION 0.61 | 2.26 Units on a scale STANDARD_DEVIATION 0.62 | 2.24 Units on a scale STANDARD_DEVIATION 0.62 | 2.30 Units on a scale STANDARD_DEVIATION 0.61 |
| Baseline instantaneous nasal symptom score (iNSS) AM Runny Nose | 2.32 Units on a scale STANDARD_DEVIATION 0.61 | 2.35 Units on a scale STANDARD_DEVIATION 0.59 | 2.34 Units on a scale STANDARD_DEVIATION 0.61 | 2.35 Units on a scale STANDARD_DEVIATION 0.64 |
| Baseline instantaneous nasal symptom score (iNSS) AM Sneezing | 1.77 Units on a scale STANDARD_DEVIATION 0.89 | 1.72 Units on a scale STANDARD_DEVIATION 0.91 | 1.77 Units on a scale STANDARD_DEVIATION 0.88 | 1.83 Units on a scale STANDARD_DEVIATION 0.83 |
| Baseline instantaneous nasal symptom score (iNSS) PM Nasal Congestion | 2.33 Units on a scale STANDARD_DEVIATION 0.57 | 2.36 Units on a scale STANDARD_DEVIATION 0.57 | 2.36 Units on a scale STANDARD_DEVIATION 0.55 | 2.39 Units on a scale STANDARD_DEVIATION 0.53 |
| Baseline instantaneous nasal symptom score (iNSS) PM Nasal Itching | 2.11 Units on a scale STANDARD_DEVIATION 0.66 | 2.17 Units on a scale STANDARD_DEVIATION 0.67 | 2.17 Units on a scale STANDARD_DEVIATION 0.66 | 2.24 Units on a scale STANDARD_DEVIATION 0.64 |
| Baseline instantaneous nasal symptom score (iNSS) PM Runny Nose | 2.23 Units on a scale STANDARD_DEVIATION 0.63 | 2.23 Units on a scale STANDARD_DEVIATION 0.66 | 2.24 Units on a scale STANDARD_DEVIATION 0.65 | 2.26 Units on a scale STANDARD_DEVIATION 0.66 |
| Baseline instantaneous nasal symptom score (iNSS) PM Sneezing | 1.81 Units on a scale STANDARD_DEVIATION 0.86 | 1.77 Units on a scale STANDARD_DEVIATION 0.85 | 1.83 Units on a scale STANDARD_DEVIATION 0.84 | 1.92 Units on a scale STANDARD_DEVIATION 0.79 |
| Baseline instantaneous total nasal symptom score (iTNSS) AM | 8.74 Units on a scale STANDARD_DEVIATION 2.05 | 8.83 Units on a scale STANDARD_DEVIATION 2.03 | 8.87 Units on a scale STANDARD_DEVIATION 2.03 | 9.05 Units on a scale STANDARD_DEVIATION 2.02 |
| Baseline instantaneous total nasal symptom score (iTNSS) AM and PM | 8.61 Units on a scale STANDARD_DEVIATION 2.06 | 8.68 Units on a scale STANDARD_DEVIATION 2.05 | 8.74 Units on a scale STANDARD_DEVIATION 2.04 | 8.94 Units on a scale STANDARD_DEVIATION 2 |
| Baseline instantaneous total nasal symptom score (iTNSS) PM | 8.48 Units on a scale STANDARD_DEVIATION 2.21 | 8.53 Units on a scale STANDARD_DEVIATION 2.22 | 8.61 Units on a scale STANDARD_DEVIATION 2.19 | 8.82 Units on a scale STANDARD_DEVIATION 2.14 |
| Baseline instantaneous total ocular symptom score (iTOSS) in subjects with (iTOSS) ≥5.0 AM | 7.17 Units on a scale STANDARD_DEVIATION 1.19 | 6.91 Units on a scale STANDARD_DEVIATION 1.19 | 7.03 Units on a scale STANDARD_DEVIATION 1.18 | 7.04 Units on a scale STANDARD_DEVIATION 1.16 |
| Baseline instantaneous total ocular symptom score (iTOSS) in subjects with (iTOSS) ≥5.0 AM and PM | 7.01 Units on a scale STANDARD_DEVIATION 1.19 | 6.79 Units on a scale STANDARD_DEVIATION 1.14 | 6.90 Units on a scale STANDARD_DEVIATION 1.15 | 6.92 Units on a scale STANDARD_DEVIATION 1.11 |
| Baseline instantaneous total ocular symptom score (iTOSS) in subjects with (iTOSS) ≥5.0 PM | 6.86 Units on a scale STANDARD_DEVIATION 1.35 | 6.67 Units on a scale STANDARD_DEVIATION 1.29 | 6.78 Units on a scale STANDARD_DEVIATION 1.29 | 6.81 Units on a scale STANDARD_DEVIATION 1.24 |
| Baseline Instantaneous Total Ocular Symptoms Scores (iTOSS)] for Onset of Nasal Improvement | 6.98 Hours STANDARD_DEVIATION 1.6 | 6.85 Hours STANDARD_DEVIATION 1.72 | 6.95 Hours STANDARD_DEVIATION 1.62 | 7.02 Hours STANDARD_DEVIATION 1.54 |
| Baseline reflective nasal symptom score (rNSS) AM and PM Nasal Congestion | 2.45 Units on a scale STANDARD_DEVIATION 0.5 | 2.53 Units on a scale STANDARD_DEVIATION 0.44 | 2.51 Units on a scale STANDARD_DEVIATION 0.46 | 2.56 Units on a scale STANDARD_DEVIATION 0.43 |
| Baseline reflective nasal symptom score (rNSS) AM and PM Nasal Itching | 2.23 Units on a scale STANDARD_DEVIATION 0.59 | 2.32 Units on a scale STANDARD_DEVIATION 0.58 | 2.30 Units on a scale STANDARD_DEVIATION 0.57 | 2.36 Units on a scale STANDARD_DEVIATION 0.53 |
| Baseline reflective nasal symptom score (rNSS) AM and PM Runny Nose | 2.36 Units on a scale STANDARD_DEVIATION 0.56 | 2.41 Units on a scale STANDARD_DEVIATION 0.55 | 2.39 Units on a scale STANDARD_DEVIATION 0.55 | 2.40 Units on a scale STANDARD_DEVIATION 0.55 |
| Baseline reflective nasal symptom score (rNSS) AM and PM Sneezing | 2.05 Units on a scale STANDARD_DEVIATION 0.65 | 2.05 Units on a scale STANDARD_DEVIATION 0.69 | 2.08 Units on a scale STANDARD_DEVIATION 0.65 | 2.14 Units on a scale STANDARD_DEVIATION 0.59 |
| Baseline reflective nasal symptom score (rNSS) AM Nasal Congestion | 2.48 Units on a scale STANDARD_DEVIATION 0.5 | 2.57 Units on a scale STANDARD_DEVIATION 0.43 | 2.55 Units on a scale STANDARD_DEVIATION 0.46 | 2.60 Units on a scale STANDARD_DEVIATION 0.43 |
| Baseline reflective nasal symptom score (rNSS) AM Nasal Itching | 2.22 Units on a scale STANDARD_DEVIATION 0.61 | 2.33 Units on a scale STANDARD_DEVIATION 0.59 | 2.30 Units on a scale STANDARD_DEVIATION 0.58 | 2.35 Units on a scale STANDARD_DEVIATION 0.54 |
| Baseline reflective nasal symptom score (rNSS) AM Runny Nose | 2.37 Units on a scale STANDARD_DEVIATION 0.57 | 2.44 Units on a scale STANDARD_DEVIATION 0.55 | 2.41 Units on a scale STANDARD_DEVIATION 0.56 | 2.41 Units on a scale STANDARD_DEVIATION 0.56 |
| Baseline reflective nasal symptom score (rNSS) AM Sneezing | 2.00 Units on a scale STANDARD_DEVIATION 0.71 | 2.02 Units on a scale STANDARD_DEVIATION 0.73 | 2.04 Units on a scale STANDARD_DEVIATION 0.69 | 2.11 Units on a scale STANDARD_DEVIATION 0.62 |
| Baseline reflective nasal symptom score (rNSS) PM Nasal Congestion | 2.42 Units on a scale STANDARD_DEVIATION 0.53 | 2.49 Units on a scale STANDARD_DEVIATION 0.51 | 2.48 Units on a scale STANDARD_DEVIATION 0.51 | 2.52 Units on a scale STANDARD_DEVIATION 0.48 |
| Baseline reflective nasal symptom score (rNSS) PM Nasal Itching | 2.25 Units on a scale STANDARD_DEVIATION 0.62 | 2.32 Units on a scale STANDARD_DEVIATION 0.61 | 2.31 Units on a scale STANDARD_DEVIATION 0.59 | 2.36 Units on a scale STANDARD_DEVIATION 0.54 |
| Baseline reflective nasal symptom score (rNSS) PM Runny Nose | 2.35 Units on a scale STANDARD_DEVIATION 0.58 | 2.39 Units on a scale STANDARD_DEVIATION 0.59 | 2.38 Units on a scale STANDARD_DEVIATION 0.58 | 2.39 Units on a scale STANDARD_DEVIATION 0.58 |
| Baseline reflective nasal symptom score (rNSS) PM Sneezing | 2.11 Units on a scale STANDARD_DEVIATION 0.64 | 2.08 Units on a scale STANDARD_DEVIATION 0.69 | 2.12 Units on a scale STANDARD_DEVIATION 0.65 | 2.17 Units on a scale STANDARD_DEVIATION 0.61 |
| Baseline reflective total nasal symptom score (rTNSS) AM | 9.08 Units on a scale STANDARD_DEVIATION 1.85 | 9.36 Units on a scale STANDARD_DEVIATION 1.76 | 9.31 Units on a scale STANDARD_DEVIATION 1.77 | 9.47 Units on a scale STANDARD_DEVIATION 1.68 |
| Baseline reflective total nasal symptom score (rTNSS) AM and PM | 9.10 Units on a scale STANDARD_DEVIATION 1.8 | 9.32 Units on a scale STANDARD_DEVIATION 1.77 | 9.29 Units on a scale STANDARD_DEVIATION 1.75 | 9.46 Units on a scale STANDARD_DEVIATION 1.67 |
| Baseline reflective total nasal symptom score (rTNSS) PM | 9.13 Units on a scale STANDARD_DEVIATION 1.87 | 9.28 Units on a scale STANDARD_DEVIATION 1.92 | 9.28 Units on a scale STANDARD_DEVIATION 1.87 | 9.44 Units on a scale STANDARD_DEVIATION 1.8 |
| Baseline reflective total ocular symptom score (rTOSS) in subjects with (rTOSS) ≥5.0 AM | 6.95 Units on a scale STANDARD_DEVIATION 1.33 | 6.89 Units on a scale STANDARD_DEVIATION 1.27 | 6.94 Units on a scale STANDARD_DEVIATION 1.27 | 6.98 Units on a scale STANDARD_DEVIATION 1.22 |
| Baseline reflective total ocular symptom score (rTOSS) in subjects with (rTOSS) ≥5.0 AM and PM | 6.95 Units on a scale STANDARD_DEVIATION 1.23 | 6.89 Units on a scale STANDARD_DEVIATION 1.19 | 6.95 Units on a scale STANDARD_DEVIATION 1.18 | 7.01 Units on a scale STANDARD_DEVIATION 1.11 |
| Baseline reflective total ocular symptom score (rTOSS) in subjects with (rTOSS) ≥5.0 PM | 6.96 Units on a scale STANDARD_DEVIATION 1.25 | 6.90 Units on a scale STANDARD_DEVIATION 1.24 | 6.97 Units on a scale STANDARD_DEVIATION 1.21 | 7.04 Units on a scale STANDARD_DEVIATION 1.13 |
| Baseline Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in subject with RQLQ(S) score ≥3. | 4.43 units on a scale STANDARD_DEVIATION 0.83 | 4.52 units on a scale STANDARD_DEVIATION 0.77 | 4.48 units on a scale STANDARD_DEVIATION 0.79 | 4.49 units on a scale STANDARD_DEVIATION 0.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 109 Participants | 109 Participants | 320 Participants | 102 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 126 Participants | 128 Participants | 387 Participants | 133 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 4 participants | 8 participants | 3 participants |
| Race/Ethnicity, Customized Black/African American | 14 participants | 13 participants | 35 participants | 8 participants |
| Race/Ethnicity, Customized Multiple | 0 participants | 2 participants | 2 participants | 0 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized White/Caucasian | 220 participants | 218 participants | 658 participants | 220 participants |
| Sex: Female, Male Female | 155 Participants | 159 Participants | 469 Participants | 155 Participants |
| Sex: Female, Male Male | 80 Participants | 78 Participants | 238 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 21 / 237 | 14 / 235 | 22 / 235 |
| serious Total, serious adverse events | 0 / 237 | 1 / 235 | 0 / 235 |
Outcome results
Primary
Change From Baseline in Daily Subject-reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Averaged Over the Two-week Treatment Period.
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 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 two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
Population: Intent to treat population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Averaged Over the Two-week Treatment Period. | -1.45 units on a scale | Standard Error 0.14 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Averaged Over the Two-week Treatment Period. | -1.59 units on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in Daily Subject-reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Averaged Over the Two-week Treatment Period. | -0.51 units on a scale | Standard Error 0.14 |
Comparison: The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.p-value: <0.000195% CI: [0.57, 1.32]ANCOVA
Comparison: The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.p-value: <0.000195% CI: [0.7, 1.45]ANCOVA
Secondary
Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Instantaneous NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period | Sneezing | -0.35 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period | Runny Nose | -0.30 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period | Nasal Itching | -0.37 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period | Nasal Congestion | -0.32 Units on a scale | Standard Error 0.03 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period | Runny Nose | -0.33 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period | Nasal Itching | -0.43 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period | Sneezing | -0.38 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period | Nasal Congestion | -0.33 Units on a scale | Standard Error 0.03 |
| Placebo | Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period | Nasal Itching | -0.15 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period | Runny Nose | -0.10 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period | Nasal Congestion | -0.33 Units on a scale | Standard Error 0.03 |
| Placebo | Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period | Sneezing | -0.12 Units on a scale | Standard Error 0.04 |
Secondary
Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
Population: In Subjects With Baseline iTOSS ≥5.0
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Redness of Eyes | -0.34 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Itching Eyes | -0.34 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Tearing Eyes | -0.33 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Redness of Eyes | -0.35 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Itching Eyes | -0.34 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Tearing Eyes | -0.38 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Itching Eyes | -0.15 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Tearing Eyes | -0.12 Units on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Redness of Eyes | -0.12 Units on a scale | Standard Error 0.05 |
Secondary
Change From Baseline in Daily Subject-reported AM and PM iTNSS Averaged Over the Two-week Treatment Period.
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 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). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
Population: Intent to treat population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM iTNSS Averaged Over the Two-week Treatment Period. | -1.34 units on a scale | Standard Error 0.13 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM iTNSS Averaged Over the Two-week Treatment Period. | -1.47 units on a scale | Standard Error 0.13 |
| Placebo | Change From Baseline in Daily Subject-reported AM and PM iTNSS Averaged Over the Two-week Treatment Period. | -0.47 units on a scale | Standard Error 0.13 |
Comparison: Dmitrienko's tree-structured gatekeeping method was used for multiple comparisonsp-value: <0.000195% CI: [0.5, 1.25]ANCOVA
Comparison: Dmitrienko's tree-structured gatekeeping method was used for multiple comparisonsp-value: <0.000195% CI: [0.63, 1.37]ANCOVA
Secondary
Change From Baseline in Daily Subject Reported AM and PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
Population: In Subjects With Baseline iTOSS ≥5.0
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject Reported AM and PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | -1.00 Units on a scale | Standard Error 0.12 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject Reported AM and PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | -1.07 Units on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline in Daily Subject Reported AM and PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | -0.40 Units on a scale | Standard Error 0.13 |
Secondary
Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period | Sneezing | -0.40 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period | Runny Nose | -0.32 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period | Nasal Itching | -0.38 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period | Nasal Congestion | -0.35 Units on a scale | Standard Error 0.03 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period | Nasal Congestion | -0.36 Units on a scale | Standard Error 0.03 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period | Sneezing | -0.44 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period | Nasal Itching | -0.43 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period | Runny Nose | -0.36 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period | Nasal Congestion | -0.11 Units on a scale | Standard Error 0.03 |
| Placebo | Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period | Runny Nose | -0.11 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period | Nasal Itching | -0.16 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period | Sneezing | -0.12 Units on a scale | Standard Error 0.04 |
Secondary
Change From Baseline in Daily Subject-reported AM and PM rTOSS Averaged Over the Two-week Treatment Period in Participants With a Baseline rTOSS >= 5.0
TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
Population: Intent to treat population. In participants with a baseline rTOSS \>= 5.0
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM rTOSS Averaged Over the Two-week Treatment Period in Participants With a Baseline rTOSS >= 5.0 | -1.06 units on a scale | Standard Error 0.12 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM and PM rTOSS Averaged Over the Two-week Treatment Period in Participants With a Baseline rTOSS >= 5.0 | -1.05 units on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline in Daily Subject-reported AM and PM rTOSS Averaged Over the Two-week Treatment Period in Participants With a Baseline rTOSS >= 5.0 | -0.44 units on a scale | Standard Error 0.12 |
Comparison: Dmitrienko's tree-structured gatekeeping method was used for multiple comparisonsp-value: 0.000495% CI: [0.28, 0.95]ANCOVA
Comparison: Dmitrienko's tree-structured gatekeeping method was used for multiple comparisonsp-value: 0.000595% CI: [0.27, 0.94]ANCOVA
Secondary
Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period | Nasal Itching | -0.38 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period | Runny Nose | -0.30 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period | Sneezing | -0.33 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period | Nasal Congestion | -0.31 Units on a scale | Standard Error 0.03 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period | Runny Nose | -0.29 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period | Sneezing | -0.33 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period | Nasal Congestion | -0.33 Units on a scale | Standard Error 0.03 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period | Nasal Itching | -0.42 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period | Sneezing | -0.10 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period | Nasal Congestion | -0.11 Units on a scale | Standard Error 0.03 |
| Placebo | Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period | Nasal Itching | -0.16 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period | Runny Nose | -0.09 Units on a scale | Standard Error 0.04 |
Secondary
Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
Population: In Subjects With Baseline iTOSS ≥5.0
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Redness of Eyes | -0.33 Units on a scale | Standard Error 0.05 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Itching Eyes | -0.33 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Tearing Eyes | -0.31 Units on a scale | Standard Error 0.05 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Redness of Eyes | -0.32 Units on a scale | Standard Error 0.05 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Itching Eyes | -0.32 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Tearing Eyes | -0.35 Units on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Itching Eyes | -0.17 Units on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Tearing Eyes | -0.13 Units on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Redness of Eyes | -0.10 Units on a scale | Standard Error 0.05 |
Secondary
Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the Two Week Treatment Period
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 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 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the Two Week Treatment Period | -1.32 Units on a scale | Standard Error 0.13 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the Two Week Treatment Period | -1.37 Units on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the Two Week Treatment Period | -0.46 Units on a scale | Standard Error 0.14 |
Secondary
Change From Baseline in Daily Subject-reported AM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
Population: In Subjects With Baseline iTOSS ≥5.0
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | -0.96 Units on a scale | Standard Error 0.13 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | -0.99 Units on a scale | Standard Error 0.13 |
| Placebo | Change From Baseline in Daily Subject-reported AM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | -0.42 Units on a scale | Standard Error 0.13 |
Secondary
Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period | Sneezing | -0.39 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period | Runny Nose | -0.32 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period | Nasal Itching | -0.38 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period | Nasal Congestion | -0.35 Units on a scale | Standard Error 0.03 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period | Nasal Congestion | -0.36 Units on a scale | Standard Error 0.03 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period | Sneezing | -0.43 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period | Nasal Itching | -0.43 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period | Runny Nose | -0.35 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period | Nasal Congestion | -0.12 Units on a scale | Standard Error 0.03 |
| Placebo | Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period | Runny Nose | -0.13 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period | Nasal Itching | -0.17 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period | Sneezing | -0.12 Units on a scale | Standard Error 0.04 |
Secondary
Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0
OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
Population: In Subjects With Baseline rTOSS ≥5.0
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Redness of Eyes | -0.32 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Itching Eyes | -0.36 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Tearing Eyes | -0.36 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Itching Eyes | -0.33 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Redness of Eyes | -0.31 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Tearing Eyes | -0.35 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Itching Eyes | -0.14 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Tearing Eyes | -0.16 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Redness of Eyes | -0.12 Units on a scale | Standard Error 0.05 |
Secondary
Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the Two Week Treatment Period
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 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 two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the Two Week Treatment Period | -1.45 Units on a scale | Standard Error 0.14 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the Two Week Treatment Period | -1.56 Units on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the Two Week Treatment Period | -0.53 Units on a scale | Standard Error 0.14 |
Secondary
Change From Baseline in Daily Subject-reported AM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0
TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
Population: In Subjects With Baseline rTOSS ≥5.0
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | -1.03 Units on a scale | Standard Error 0.12 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported AM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | -0.98 Units on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline in Daily Subject-reported AM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | -0.41 Units on a scale | Standard Error 0.13 |
Secondary
Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0
OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
Population: In Subjects With Baseline rTOSS ≥5.0
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Redness of Eyes | -0.33 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Tearing Eyes | -0.38 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Itching Eyes | -0.35 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Tearing Eyes | -0.38 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Redness of Eyes | -0.32 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Itching Eyes | -0.34 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Redness of Eyes | -0.14 Units on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Itching Eyes | -0.14 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Tearing Eyes | -0.16 Units on a scale | Standard Error 0.04 |
Secondary
Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period | Nasal Congestion | -0.33 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period | Nasal Itching | -0.35 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period | Sneezing | -0.37 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period | Runny Nose | -0.30 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period | Nasal Itching | -0.44 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period | Sneezing | -0.43 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period | Runny Nose | -0.35 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period | Nasal Congestion | -0.33 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period | Nasal Itching | -0.14 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period | Nasal Congestion | -0.09 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period | Sneezing | -0.14 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period | Runny Nose | -0.11 Units on a scale | Standard Error 0.04 |
Secondary
Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
Population: In Subjects With Baseline iTOSS ≥5.0
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Redness of Eyes | -0.36 Units on a scale | Standard Error 0.05 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Itching Eyes | -0.34 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Tearing Eyes | -0.36 Units on a scale | Standard Error 0.05 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Redness of Eyes | -0.38 Units on a scale | Standard Error 0.05 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Itching Eyes | -0.36 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Tearing Eyes | -0.42 Units on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Itching Eyes | -0.13 Units on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Tearing Eyes | -0.10 Units on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | Redness of Eyes | -0.13 Units on a scale | Standard Error 0.05 |
Secondary
Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the Two Week Treatment Period
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 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). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the Two Week Treatment Period | -1.36 Units on a scale | Standard Error 0.14 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the Two Week Treatment Period | -1.55 Units on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the Two Week Treatment Period | -0.49 Units on a scale | Standard Error 0.14 |
Secondary
Change From Baseline in Daily Subject-reported PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
Population: In Subjects With Baseline iTOSS ≥5.0
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | -1.06 Units on a scale | Standard Error 0.13 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | -1.16 Units on a scale | Standard Error 0.13 |
| Placebo | Change From Baseline in Daily Subject-reported PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0 | -0.36 Units on a scale | Standard Error 0.14 |
Secondary
Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period
NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period | Sneezing | -0.41 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period | Runny Nose | -0.32 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period | Nasal Itching | -0.38 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period | Nasal Congestion | -0.35 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period | Nasal Congestion | -0.35 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period | Runny Nose | -0.37 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period | Sneezing | -0.46 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period | Nasal Itching | -0.44 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period | Sneezing | -0.13 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period | Runny Nose | -0.10 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period | Nasal Itching | -0.17 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period | Nasal Congestion | -0.11 Units on a scale | Standard Error 0.04 |
Secondary
Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0
OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
Population: In Subjects With Baseline rTOSS ≥5.0
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Redness of Eyes | -0.35 Units on a scale | Standard Error 0.05 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Itching Eyes | -0.34 Units on a scale | Standard Error 0.04 |
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Tearing Eyes | -0.39 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Redness of Eyes | -0.34 Units on a scale | Standard Error 0.05 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Itching Eyes | -0.35 Units on a scale | Standard Error 0.04 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Tearing Eyes | -0.42 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Itching Eyes | -0.14 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Tearing Eyes | -0.16 Units on a scale | Standard Error 0.05 |
| Placebo | Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | Redness of Eyes | -0.16 Units on a scale | Standard Error 0.05 |
Secondary
Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the Two Week Treatment Period
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 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 two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the Two Week Treatment Period | -1.46 Units on a scale | Standard Error 0.14 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the Two Week Treatment Period | -1.60 Units on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the Two Week Treatment Period | -0.51 Units on a scale | Standard Error 0.14 |
Secondary
Change From Baseline in Daily Subject-reported PM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0
TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Week 0-2
Population: In Subjects With Baseline rTOSS ≥5.0
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | -1.09 Units on a scale | Standard Error 0.12 |
| 160 mcg Ciclesonide | Change From Baseline in Daily Subject-reported PM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | -1.11 Units on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline in Daily Subject-reported PM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0 | -0.47 Units on a scale | Standard Error 0.13 |
Secondary
Change From Baseline in Overall Score of the Rhinoconjunctivitis Quality of Life Questionnaire With Standard Activities (RQLQ(S)) in Participants With a Baseline Overall Score >= 3.0
The RQLQ(S) in impaired subjects (baseline RQLQ\[S\] score ≥3.0) at baseline and end of week 2. It consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.
Time frame: Week 0-2
Population: In participants with a Baseline overall score \>= 3.0
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 80 mcg Ciclesonide | Change From Baseline in Overall Score of the Rhinoconjunctivitis Quality of Life Questionnaire With Standard Activities (RQLQ(S)) in Participants With a Baseline Overall Score >= 3.0 | -1.05 units on a scale | Standard Error 0.1 |
| 160 mcg Ciclesonide | Change From Baseline in Overall Score of the Rhinoconjunctivitis Quality of Life Questionnaire With Standard Activities (RQLQ(S)) in Participants With a Baseline Overall Score >= 3.0 | -1.07 units on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline in Overall Score of the Rhinoconjunctivitis Quality of Life Questionnaire With Standard Activities (RQLQ(S)) in Participants With a Baseline Overall Score >= 3.0 | -0.42 units on a scale | Standard Error 0.1 |
Secondary
Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS)
Onset of nasal improvement was defined as the first assessment at which iTNSS for active treatment demonstrated an improvement over placebo from baseline. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and 12 reflecting more severe symptoms). Instaneous measures these symptoms over the previous 10 minute time interval.
Time frame: Baseline and up to 36 hours
Population: Intent to Treat Population. Some participants excluded for missing data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 1, 10 Hours Postdose (n=237,232,231) | -1.34 Units on a scale | Standard Error 0.16 |
| 80 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 1, 4 Hours Postdose (n=237, 233, 233) | -0.77 Units on a scale | Standard Error 0.15 |
| 80 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 1, 6 Hours Postdose (n=235, 234, 231) | -1.19 Units on a scale | Standard Error 0.16 |
| 80 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 1, 8 Hours Postdose (n=236, 233, 233) | -1.31 Units on a scale | Standard Error 0.16 |
| 80 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 1, 12 Hours Postdose (n=236, 233, 233) | -1.14 Units on a scale | Standard Error 0.16 |
| 80 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 2, Predose (n=237,234,233) | -0.57 Units on a scale | Standard Error 0.15 |
| 80 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 2, 6 Hours Postdose (n=237,233,231) | -1.56 Units on a scale | Standard Error 0.17 |
| 80 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 2, 12 Hours Postdose (n=235,233,232) | -1.35 Units on a scale | Standard Error 0.16 |
| 160 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 2, 6 Hours Postdose (n=237,233,231) | -1.59 Units on a scale | Standard Error 0.17 |
| 160 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 1, 10 Hours Postdose (n=237,232,231) | -1.19 Units on a scale | Standard Error 0.16 |
| 160 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 1, 12 Hours Postdose (n=236, 233, 233) | -1.15 Units on a scale | Standard Error 0.16 |
| 160 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 2, Predose (n=237,234,233) | -0.81 Units on a scale | Standard Error 0.15 |
| 160 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 1, 4 Hours Postdose (n=237, 233, 233) | -0.79 Units on a scale | Standard Error 0.15 |
| 160 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 2, 12 Hours Postdose (n=235,233,232) | -1.59 Units on a scale | Standard Error 0.17 |
| 160 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 1, 6 Hours Postdose (n=235, 234, 231) | -1.36 Units on a scale | Standard Error 0.16 |
| 160 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 1, 8 Hours Postdose (n=236, 233, 233) | -1.35 Units on a scale | Standard Error 0.16 |
| Placebo | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 1, 4 Hours Postdose (n=237, 233, 233) | -0.84 Units on a scale | Standard Error 0.15 |
| Placebo | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 1, 8 Hours Postdose (n=236, 233, 233) | -1.14 Units on a scale | Standard Error 0.16 |
| Placebo | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 2, Predose (n=237,234,233) | -0.45 Units on a scale | Standard Error 0.15 |
| Placebo | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 1, 10 Hours Postdose (n=237,232,231) | -0.90 Units on a scale | Standard Error 0.16 |
| Placebo | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 2, 6 Hours Postdose (n=237,233,231) | -1.16 Units on a scale | Standard Error 0.17 |
| Placebo | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 1, 6 Hours Postdose (n=235, 234, 231) | -1.19 Units on a scale | Standard Error 0.16 |
| Placebo | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 1, 12 Hours Postdose (n=236, 233, 233) | -0.87 Units on a scale | Standard Error 0.16 |
| Placebo | Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS) | Day 2, 12 Hours Postdose (n=235,233,232) | -0.77 Units on a scale | Standard Error 0.17 |
Secondary
Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0
Onset of improvement iTOSS was defined as the first assessment at which iTOSSS for active treatment demonstrated an improvement over placebo from baseline. TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval.
Time frame: Baseline and up to 48 hours
Population: In Subjects With Baseline iTOSS ≥5.0
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 1, 4 Hours Postdose (n=149, 150, 132) | -0.69 Units on a scale | Standard Error 0.14 |
| 80 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 1, 6 Hours Postdose (n=149, 150, 132) | -0.93 Units on a scale | Standard Error 0.16 |
| 80 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 1, 8 Hours Postdose (n=148, 150, 132) | -0.97 Units on a scale | Standard Error 0.15 |
| 80 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 1, 10 Hours Postdose (n=149, 150, 132) | -1.02 Units on a scale | Standard Error 0.16 |
| 80 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 1, 12 Hours Postdose (n=149, 148, 132) | -0.80 Units on a scale | Standard Error 0.15 |
| 80 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 2, Predose (n=149, 149, 132) | -0.29 Units on a scale | Standard Error 0.15 |
| 80 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 2, 6 Hours Postdose (n=149, 150, 131) | -1.11 Units on a scale | Standard Error 0.16 |
| 80 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 2, 12 Hours Postdose (n=149, 149, 132) | -1.09 Units on a scale | Standard Error 0.16 |
| 160 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 1, 8 Hours Postdose (n=148, 150, 132) | -0.97 Units on a scale | Standard Error 0.15 |
| 160 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 2, 6 Hours Postdose (n=149, 150, 131) | -1.15 Units on a scale | Standard Error 0.16 |
| 160 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 1, 10 Hours Postdose (n=149, 150, 132) | -0.79 Units on a scale | Standard Error 0.15 |
| 160 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 1, 12 Hours Postdose (n=149, 148, 132) | -0.83 Units on a scale | Standard Error 0.15 |
| 160 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 2, Predose (n=149, 149, 132) | -0.37 Units on a scale | Standard Error 0.15 |
| 160 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 1, 4 Hours Postdose (n=149, 150, 132) | -0.57 Units on a scale | Standard Error 0.14 |
| 160 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 1, 6 Hours Postdose (n=149, 150, 132) | -0.83 Units on a scale | Standard Error 0.16 |
| 160 mcg Ciclesonide | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 2, 12 Hours Postdose (n=149, 149, 132) | -1.26 Units on a scale | Standard Error 0.16 |
| Placebo | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 1, 8 Hours Postdose (n=148, 150, 132) | -0.72 Units on a scale | Standard Error 0.16 |
| Placebo | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 1, 6 Hours Postdose (n=149, 150, 132) | -0.75 Units on a scale | Standard Error 0.17 |
| Placebo | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 1, 4 Hours Postdose (n=149, 150, 132) | -0.53 Units on a scale | Standard Error 0.15 |
| Placebo | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 1, 10 Hours Postdose (n=149, 150, 132) | -0.69 Units on a scale | Standard Error 0.17 |
| Placebo | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 2, 6 Hours Postdose (n=149, 150, 131) | -0.71 Units on a scale | Standard Error 0.17 |
| Placebo | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 2, Predose (n=149, 149, 132) | -0.09 Units on a scale | Standard Error 0.16 |
| Placebo | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 1, 12 Hours Postdose (n=149, 148, 132) | -0.49 Units on a scale | Standard Error 0.16 |
| Placebo | Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0 | Day 2, 12 Hours Postdose (n=149, 149, 132) | -0.47 Units on a scale | Standard Error 0.17 |
Secondary
Time to Maximal Effect as Measured by Change From Baseline in the Average AM and PM Reflective Total Nasal Symptoms Scores (rTNSS)
The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between Ciclesonide HFA and placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day.
Time frame: Week 0-2
Population: Intent to Treat Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 80 mcg Ciclesonide | Time to Maximal Effect as Measured by Change From Baseline in the Average AM and PM Reflective Total Nasal Symptoms Scores (rTNSS) | 13 days | Standard Error 0.2 |
| 160 mcg Ciclesonide | Time to Maximal Effect as Measured by Change From Baseline in the Average AM and PM Reflective Total Nasal Symptoms Scores (rTNSS) | 8 days | Standard Error 0.17 |