PAR, Perennial Allergic Rhinitis
Conditions
Brief summary
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.
Detailed description
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR. This study will consist of the following periods/visits: Screening , Single-blind Placebo Run-in period, Double-blind Treatment period , Follow-up. The total duration of subject participation will be approximately 5 months.
Interventions
ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
DRUGPlacebo
Placebo - one dose per nostril
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Gives written informed consent (parent/legal guardian) and assent (from the child), including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation. * Is a male or premenarchal female 6 to 11 years old at the screening visit. * Is in general good health (defined as the absence of any clinically relevant abnormalities as determined by the investigator) based on screening physical examination and medical history. * Has a history of PAR to a relevant perennial allergen (house dust mites, cockroaches, molds, and animal dander) for a minimum of 1 year immediately preceding the study screening visit. The PAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and require treatment throughout the entire study period. * Has a demonstrated sensitivity to at least 1 allergen known to induce PAR (house dust mites, cockroaches, molds, and animal dander) based on a documented result with a standard skin-prick test either within 12 months prior to screening visit or performed at the screening visit. A positive test is defined as a wheal diameter at least 3 mm larger than the negative control wheal for the skin-prick test. The subject's positive allergen test must be consistent with the medical history of PAR, and the allergen must be present in the subject's environment throughout the study. * 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 PRQLQ
Exclusion criteria
* Has a history of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations; recent unhealed nasal biopsy; nasal trauma; or nasal ulcers or perforations. Surgery and atrophic rhinitis or rhinitis medicamentosa are not permitted within the 120 days prior to the screening visit. * Has evidence of infection, significant anatomic abnormality, ulceration of the mucosa, blood in the nose, or any other clinically relevant finding on nasal examination at the screening visit. * Has nasal jewelry. * Has participated in any investigational drug trial within the 30 days preceding the screening visit or is planning participation in another investigational drug trial at any time during this trial. * Has a known hypersensitivity to any corticosteroid or any of the excipients in the formulation of ciclesonide. * Has a history of a respiratory infection or disorder, including but not limited to bronchitis, pneumonia, influenza, and severe acute respiratory syndrome, within the 14 days preceding the screening visit. * Has active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta-agonists and any controller drugs (eg, theophylline, leukotriene antagonists); intermittent use (≤ 3 uses per week) of inhaled short-acting beta-agonists is acceptable. Use of short-acting beta-agonists for exercise-induced bronchospasm will be allowed. * Is expecting to use any disallowed concomitant medications during the treatment period. * Is, in the investigator's judgment, having a seasonal exacerbation at the time of the screening visit or is likely to have one during the study. * Is planning 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. * Has nonvaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the screening visit. * Initiates pimecrolimus cream 1% or greater or tacrolimus ointment 0.03% or greater during the study period or plans a dose escalation during the study period. However, initiation of these creams/ointments 30 days or more prior to screening and use of a stable (maintenance) dose during the study period may be considered for inclusion. * Is a child or relative of any clinical investigator or site personnel, even those who are not directly involved in this study. * Resides in the same household as another subject who is participating in this study. * Has any of the following conditions that are judged by the investigator to be clinically significant and/or to affect the subject's ability to participate in the clinical trial: * impaired hepatic function * history of ocular disturbances, eg, glaucoma or posterior subcapsular cataracts or herpes simplex * any systemic infection * hematological (including anemia), hepatic, renal, endocrine disease * gastrointestinal disease * malignancy (excluding basal cell carcinoma) * current neuropsychological condition with or without drug therapy. Any behavioral condition that could affect the subject's ability to accurately report symptoms to the caregiver such as developmental delay, attention deficit disorder, and autism. * Has any condition that, in the judgment of the investigator, would preclude the subject from completing the protocol with the capture of the assessments as written. * Has received ciclesonide nasal aerosol in a previous clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Averaged Weekly Over the First 6 Weeks of the Double-blind Treatment. | Weeks 0-6 | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual 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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the First 6 Weeks of Double-blind Treatment | Weeks 0 -6 | PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses. |
| Change From Baseline in Daily Average Subject-reported AM and PM rTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period | Weeks 0 -12 | 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 twelve week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement |
| Change From Baseline in Daily Average Subject-reported AM and PM iTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period | Weeks 0 -12 | 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 higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the twelve week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Change From Baseline in Daily Average Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment | Weeks 0 -6 | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual 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 higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Change From Baseline in Daily PRQLQ Overall Score at the End of the 12-week Double-blind Treatment Period | Weeks 0 -12 | PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses. |
| Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Averaged Weekly Over the First 6 Weeks of Double-blind Treatment | Weeks 0 -6 | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual 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 higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Weeks 0 -12 | — |
| Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Weeks 0 -12 | — |
| Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | Weeks 0 -12 | — |
| Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | Weeks 0 -12 | — |
| Time to Maximal Effect [Time to >= 90% Maximum Difference From Placebo in LS Means (Days)] | Weeks 0 -6 | The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between active ciclesonide nasal aerosol and placebo is at least 90% of the largest estimated difference.This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The time to achieve at least 90% of these estimated differences was calculated. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo: placebo - one dose per nostril | 283 |
| Ciclesonide Nasal Aerosol 37mcg ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily | 282 |
| Ciclesonide Nasal Aerosol 74 mcg ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily | 281 |
| Total | 846 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 4 | 3 | 6 |
| Overall Study | Lack of Efficacy | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 4 | 4 | 7 |
| Overall Study | randomization error, noncompliance | 11 | 10 | 8 |
| Overall Study | Withdrawal by Subject | 15 | 8 | 6 |
Baseline characteristics
| Characteristic | Placebo | Ciclesonide Nasal Aerosol 37mcg | Ciclesonide Nasal Aerosol 74 mcg | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 283 Participants | 282 Participants | 281 Participants | 846 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 89 participants | 101 participants | 91 participants | 281 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 194 participants | 181 participants | 190 participants | 565 participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 participants | 0 participants | 0 participants | 0 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 2 Participants | 7 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 37 Participants | 43 Participants | 39 Participants | 119 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 10 Participants | 8 Participants | 26 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 9 Participants | 9 Participants | 27 Participants |
| Race (NIH/OMB) White | 224 Participants | 216 Participants | 216 Participants | 656 Participants |
| Region of Enrollment United States | 283 participants | 282 participants | 281 participants | 846 participants |
| Sex: Female, Male Female | 120 Participants | 113 Participants | 130 Participants | 363 Participants |
| Sex: Female, Male Male | 163 Participants | 169 Participants | 151 Participants | 483 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 | 83 / 283 | 95 / 282 | 85 / 281 |
| serious Total, serious adverse events | 1 / 283 | 1 / 282 | 2 / 281 |
Outcome results
Primary
The Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Averaged Weekly Over the First 6 Weeks of the Double-blind Treatment.
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Weeks 0-6
Population: The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Averaged Weekly Over the First 6 Weeks of the Double-blind Treatment. | -1.51 units on a scale | Standard Error 0.13 |
| Ciclesonide Nasal Aerosol 37mcg | The Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Averaged Weekly Over the First 6 Weeks of the Double-blind Treatment. | -2.10 units on a scale | Standard Error 0.13 |
| Ciclesonide Nasal Aerosol 74 mcg | The Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Averaged Weekly Over the First 6 Weeks of the Double-blind Treatment. | -1.98 units on a scale | Standard Error 0.131 |
Comparison: Using an estimate of the standard deviation of 2.2 for the change from baseline in daily average subject-reported AM and PM rTNSS averaged over the first 6 weeks of double-blind treatment, 284 subjects per treatment group would have provided 90% power to detect a mean difference between treatment groups of 0.6 in the change from baseline with a 2-sided significance level of 0.05. Approx. 852 subjects were randomly assigned in a 1:1:1 ratio (ie, approximately 284 subjects per treatment group).p-value: <0.05Bonferroni-based gatekeeping method
Comparison: Using an estimate of the standard deviation of 2.2 for the change from baseline in daily average subject-reported AM and PM rTNSS averaged over the first 6 weeks of double-blind treatment, 284 subjects per treatment group would have provided 90% power to detect a mean difference between treatment groups of 0.6 in the change from baseline with a 2-sided significance level of 0.05. Approx. 852 subjects were randomly assigned in a 1:1:1 ratio (ie, approximately 284 subjects per treatment group).p-value: <0.05Bonferroni-based gatekeeping method
Secondary
Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Averaged Weekly Over the First 6 Weeks of Double-blind Treatment
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Weeks 0 -6
Population: The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Averaged Weekly Over the First 6 Weeks of Double-blind Treatment | -1.29 units on a scale | Standard Error 0.122 |
| Ciclesonide Nasal Aerosol 37mcg | Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Averaged Weekly Over the First 6 Weeks of Double-blind Treatment | -1.77 units on a scale | Standard Error 0.122 |
| Ciclesonide Nasal Aerosol 74 mcg | Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Averaged Weekly Over the First 6 Weeks of Double-blind Treatment | -1.72 units on a scale | Standard Error 0.123 |
Secondary
Change From Baseline in Daily Average Subject-reported AM and PM iTNSS Averaged Weekly Over the 12-week Double-blind 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, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the twelve week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Weeks 0 -12
Population: The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Daily Average Subject-reported AM and PM iTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period | -1.69 units on a scale | Standard Error 0.13 |
| Ciclesonide Nasal Aerosol 37mcg | Change From Baseline in Daily Average Subject-reported AM and PM iTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period | -2.22 units on a scale | Standard Error 0.13 |
| Ciclesonide Nasal Aerosol 74 mcg | Change From Baseline in Daily Average Subject-reported AM and PM iTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period | -2.15 units on a scale | Standard Error 0.13 |
Secondary
Change From Baseline in Daily Average Subject-reported AM and PM rTNSS Averaged Weekly Over the 12-week Double-blind 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 twelve week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement
Time frame: Weeks 0 -12
Population: The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Daily Average Subject-reported AM and PM rTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period | -1.92 units on a scale | Standard Error 0.13 |
| Ciclesonide Nasal Aerosol 37mcg | Change From Baseline in Daily Average Subject-reported AM and PM rTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period | -2.60 units on a scale | Standard Error 0.14 |
| Ciclesonide Nasal Aerosol 74 mcg | Change From Baseline in Daily Average Subject-reported AM and PM rTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period | -2.47 units on a scale | Standard Error 0.14 |
Secondary
Change From Baseline in Daily Average Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Weeks 0 -6
Population: The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Daily Average Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment | -1.26 units on a scale | Standard Error 0.12 |
| Ciclesonide Nasal Aerosol 37mcg | Change From Baseline in Daily Average Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment | -1.75 units on a scale | Standard Error 0.12 |
| Ciclesonide Nasal Aerosol 74 mcg | Change From Baseline in Daily Average Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment | -1.74 units on a scale | Standard Error 0.12 |
Secondary
Change From Baseline in Daily PRQLQ Overall Score at the End of the 12-week Double-blind Treatment Period
PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses.
Time frame: Weeks 0 -12
Population: The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Daily PRQLQ Overall Score at the End of the 12-week Double-blind Treatment Period | -0.54 units on a scale | Standard Error 0.059 |
| Ciclesonide Nasal Aerosol 37mcg | Change From Baseline in Daily PRQLQ Overall Score at the End of the 12-week Double-blind Treatment Period | -0.68 units on a scale | Standard Error 0.059 |
| Ciclesonide Nasal Aerosol 74 mcg | Change From Baseline in Daily PRQLQ Overall Score at the End of the 12-week Double-blind Treatment Period | -0.47 units on a scale | Standard Error 0.059 |
Secondary
Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the First 6 Weeks of Double-blind Treatment
PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses.
Time frame: Weeks 0 -6
Population: The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the First 6 Weeks of Double-blind Treatment | -0.39 units on a scale | Standard Error 0.05 |
| Ciclesonide Nasal Aerosol 37mcg | Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the First 6 Weeks of Double-blind Treatment | -0.51 units on a scale | Standard Error 0.05 |
| Ciclesonide Nasal Aerosol 74 mcg | Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the First 6 Weeks of Double-blind Treatment | -0.30 units on a scale | Standard Error 0.054 |
Secondary
Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs
Time frame: Weeks 0 -12
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Any TEAE during first 6 weeks of double-blind | 114 participants |
| Placebo | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Discontinued study drug due to an AE | 4 participants |
| Placebo | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Local AE | 49 participants |
| Placebo | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Any TEAE | 154 participants |
| Placebo | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Serious AE | 1 participants |
| Placebo | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Severe AE | 12 participants |
| Placebo | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Potentially related AE | 46 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Local AE | 45 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Any TEAE | 142 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Any TEAE during first 6 weeks of double-blind | 99 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Potentially related AE | 39 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Discontinued study drug due to an AE | 3 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Severe AE | 14 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Serious AE | 1 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Discontinued study drug due to an AE | 6 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Any TEAE during first 6 weeks of double-blind | 102 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Serious AE | 2 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Severe AE | 17 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Local AE | 46 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Potentially related AE | 46 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Any TEAE | 143 participants |
Secondary
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
Time frame: Weeks 0 -12
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL DISCOMFORT | 6 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SNEEZING | 7 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | POSTNASAL DRIP | 0 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL DRYNESS | 0 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | ACUTE SINUSITIS | 1 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL ULCER | 0 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL MUCOSAL DISCOLOURATION | 0 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | INCREASED UPPER AIRWAY SECRETION | 1 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL TURBINATE ABNORMALITY | 1 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL MUCOSAL DISORDER | 4 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SINUSITIS | 5 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL SEPTUM ULCERATION | 1 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL OEDEMA | 4 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SCRATCH | 1 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL SEPTUM DISORDER | 0 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | MUCOSAL DISCOLOURATION | 1 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | EPISTAXIS | 26 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SCAB | 1 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | MUCOSAL EXCORIATION | 0 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | APPLICATION SITE PAIN | 3 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | RHINORRHOEA | 2 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | MUCOSAL HAEMORRHAGE | 0 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SINUS HEADACHE | 0 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | RHINITIS PERENNIAL | 4 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL CONGESTION | 0 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | FACE INJURY | 2 participants |
| Placebo | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | RHINALGIA | 0 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SCRATCH | 0 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | ACUTE SINUSITIS | 2 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | APPLICATION SITE PAIN | 3 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | EPISTAXIS | 20 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | FACE INJURY | 1 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | INCREASED UPPER AIRWAY SECRETION | 0 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | MUCOSAL DISCOLOURATION | 0 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | MUCOSAL EXCORIATION | 1 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | MUCOSAL HAEMORRHAGE | 0 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL CONGESTION | 3 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL DISCOMFORT | 4 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL DRYNESS | 0 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL MUCOSAL DISCOLOURATION | 1 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL MUCOSAL DISORDER | 0 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL OEDEMA | 3 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL SEPTUM DISORDER | 1 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL SEPTUM ULCERATION | 0 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL TURBINATE ABNORMALITY | 1 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL ULCER | 0 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | POSTNASAL DRIP | 1 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | RHINALGIA | 0 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | RHINITIS PERENNIAL | 0 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | RHINORRHOEA | 1 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SCAB | 0 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SINUS HEADACHE | 1 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SINUSITIS | 6 participants |
| Ciclesonide Nasal Aerosol 37mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SNEEZING | 1 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL DISCOMFORT | 8 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | ACUTE SINUSITIS | 1 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | POSTNASAL DRIP | 1 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL CONGESTION | 1 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SINUS HEADACHE | 1 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | RHINALGIA | 1 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | MUCOSAL HAEMORRHAGE | 1 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | APPLICATION SITE PAIN | 1 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | RHINITIS PERENNIAL | 1 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | MUCOSAL EXCORIATION | 0 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SNEEZING | 0 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | RHINORRHOEA | 1 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | MUCOSAL DISCOLOURATION | 0 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SINUSITIS | 4 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SCAB | 2 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL OEDEMA | 3 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | INCREASED UPPER AIRWAY SECRETION | 0 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL SEPTUM DISORDER | 1 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL MUCOSAL DISORDER | 2 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | FACE INJURY | 4 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL SEPTUM ULCERATION | 1 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL MUCOSAL DISCOLOURATION | 0 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SCRATCH | 0 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL TURBINATE ABNORMALITY | 2 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL DRYNESS | 1 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | EPISTAXIS | 26 participants |
| Ciclesonide Nasal Aerosol 74 mcg | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL ULCER | 1 participants |
Secondary
Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs
Time frame: Weeks 0 -12
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Any TEAE during first 6 weeks of double-blind | 40.3 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Discontinued study drug due to an AE | 4 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Local AE | 17.3 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Any TEAE | 54.4 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Serious AE | 0.4 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Severe AE | 4.2 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Potentially related AE | 16.3 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Local AE | 16.0 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Any TEAE | 50.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Any TEAE during first 6 weeks of double-blind | 35.1 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Potentially related AE | 13.8 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Discontinued study drug due to an AE | 3 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Severe AE | 5.0 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Serious AE | 0.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Discontinued study drug due to an AE | 6 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Any TEAE during first 6 weeks of double-blind | 36.3 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Serious AE | 0.7 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Severe AE | 6.0 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Local AE | 16.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Potentially related AE | 16.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Any TEAE | 50.9 percentage of subjects |
Secondary
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
Time frame: Weeks 0 -12
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL DISCOMFORT | 2.1 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SNEEZING | 2.5 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | POSTNASAL DRIP | 0 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL DRYNESS | 0 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | ACUTE SINUSITIS | 0.4 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL ULCER | 0 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL MUCOSAL DISCOLOURATION | 0 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | INCREASED UPPER AIRWAY SECRETION | 0.4 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL TURBINATE ABNORMALITY | 0.4 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL MUCOSAL DISORDER | 1.4 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SINUSITIS | 1.8 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL SEPTUM ULCERATION | 0.4 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL OEDEMA | 1.4 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SCRATCH | 0.4 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL SEPTUM DISORDER | 0 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | MUCOSAL DISCOLOURATION | 0.4 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | EPISTAXIS | 9.2 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SCAB | 0.4 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | MUCOSAL EXCORIATION | 0 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | APPLICATION SITE PAIN | 1.1 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | RHINORRHOEA | 0.7 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | MUCOSAL HAEMORRHAGE | 0 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SINUS HEADACHE | 0 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | RHINITIS PERENNIAL | 1.4 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL CONGESTION | 0 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | FACE INJURY | 0.7 percentage of subjects |
| Placebo | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | RHINALGIA | 0 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SCRATCH | 0 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | ACUTE SINUSITIS | 0.7 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | APPLICATION SITE PAIN | 1.1 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | EPISTAXIS | 7.1 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | FACE INJURY | 0.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | INCREASED UPPER AIRWAY SECRETION | 0 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | MUCOSAL DISCOLOURATION | 0 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | MUCOSAL EXCORIATION | 0.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | MUCOSAL HAEMORRHAGE | 0 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL CONGESTION | 1.1 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL DISCOMFORT | 1.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL DRYNESS | 0 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL MUCOSAL DISCOLOURATION | 0.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL MUCOSAL DISORDER | 0 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL OEDEMA | 1.1 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL SEPTUM DISORDER | 0.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL SEPTUM ULCERATION | 0 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL TURBINATE ABNORMALITY | 0.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL ULCER | 0 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | POSTNASAL DRIP | 0.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | RHINALGIA | 0 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | RHINITIS PERENNIAL | 0 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | RHINORRHOEA | 0.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SCAB | 0 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SINUS HEADACHE | 0.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SINUSITIS | 2.1 percentage of subjects |
| Ciclesonide Nasal Aerosol 37mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SNEEZING | 0.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL DISCOMFORT | 2.8 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | ACUTE SINUSITIS | 0.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | POSTNASAL DRIP | 0.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL CONGESTION | 0.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SINUS HEADACHE | 0.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | RHINALGIA | 0.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | MUCOSAL HAEMORRHAGE | 0.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | APPLICATION SITE PAIN | 0.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | RHINITIS PERENNIAL | 0.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | MUCOSAL EXCORIATION | 0 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SNEEZING | 0 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | RHINORRHOEA | 0.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | MUCOSAL DISCOLOURATION | 0 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SINUSITIS | 1.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SCAB | 0.7 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL OEDEMA | 1.1 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | INCREASED UPPER AIRWAY SECRETION | 0 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL SEPTUM DISORDER | 0.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL MUCOSAL DISORDER | 0.7 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | FACE INJURY | 1.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL SEPTUM ULCERATION | 0.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL MUCOSAL DISCOLOURATION | 0 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | SCRATCH | 0 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL TURBINATE ABNORMALITY | 0.7 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL DRYNESS | 0.4 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | EPISTAXIS | 9.3 percentage of subjects |
| Ciclesonide Nasal Aerosol 74 mcg | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | NASAL ULCER | 0.4 percentage of subjects |
Secondary
Time to Maximal Effect [Time to >= 90% Maximum Difference From Placebo in LS Means (Days)]
The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between active ciclesonide nasal aerosol and placebo is at least 90% of the largest estimated difference.This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The time to achieve at least 90% of these estimated differences was calculated.
Time frame: Weeks 0 -6
Population: The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Time to Maximal Effect [Time to >= 90% Maximum Difference From Placebo in LS Means (Days)] | 39 Number of Days |
| Ciclesonide Nasal Aerosol 37mcg | Time to Maximal Effect [Time to >= 90% Maximum Difference From Placebo in LS Means (Days)] | 10 Number of Days |