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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ciclesonide nasal aerosol 37mcg | Active Comparator | ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily |
|
| ciclesonide nasal aerosol 74 mcg | Active Comparator | ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclesonide nasal aerosol 37 mcg | Drug | ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weeks 0-6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Respiratory Medical Director, MD | Sumitomo Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | United States | ||
| Arkansas Pediatric Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: placebo - one dose per nostril |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ciclesonide nasal aerosol 74 mcg | Drug | ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg |
|
| Placebo | Drug | Placebo - one dose per nostril |
|
| Weeks 0 -6 |
| 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. | Weeks 0 -6 |
| 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 | Weeks 0 -12 |
| 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. | Weeks 0 -12 |
| 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. | Weeks 0 -6 |
| 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. | Weeks 0 -12 |
| 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. | Weeks 0 -6 |
| 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 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| West Coast Clinical Trials, LLC | Costa Mesa | California | 92626 | United States |
| Premier Health Research Center | Downey | California | 90241 | United States |
| Allergy and Asthma Specialists Medical Group | Huntington Beach | California | 92647 | United States |
| Pediatric Care Medical Group | Huntington Beach | California | 92647 | United States |
| Allergy and Asthma Assoc of Southern CA | Mission Veijo | California | 92691 | United States |
| Center for Clinical Trials, LLC | Paramount | California | 90723 | United States |
| Allergy Associates Medical Group | San Diego | California | 92120 | United States |
| Allergy and Asthma Medical Group & Research Center | San Diego | California | 92123 | United States |
| Sansum Clinic | Santa Barbara | California | 93110 | United States |
| Colorado Allergy and Asthma Centers, PC | Centennial | Colorado | 80112 | United States |
| IMMUNOe International Research Centers | Centennial | Colorado | 80112 | United States |
| Storms Clinical Research Institute | Colorado Springs | Colorado | 80907 | United States |
| Ashtma and Allergy Associates | Pueblo | Colorado | 81001 | United States |
| DataQuest Medical Research, LLC | Lawerenceville | Georgia | 30045 | United States |
| Aeroallergy Research Labs of Savannah | Savannah | Georgia | 31406 | United States |
| Atlanta Allergy and Asthma Clinic | Stockbridge | Georgia | 30281 | United States |
| Clinical Research Atlanta | Stockton | Georgia | 30281 | United States |
| Sneeze, Wheeze, & Itch Associates, LLC | Normal | Illinois | 61761 | United States |
| College Park Family Care Center | Lenexa | Kansas | 66215 | United States |
| Family Allergy and Asthma Research Institute | Louisville | Kentucky | 40215 | United States |
| Gordon Raphael, MD | Bethesda | Maryland | 20814 | United States |
| Northeast Medical Research Associates Inc | North Dartmouth | Massachusetts | 02747 | United States |
| Respiratory Medicine Research Institute of Michigan, PLC | Ypsilanti | Michigan | 48197 | United States |
| Clinical Research Institute Inc | Plymouth | Minnesota | 55441 | United States |
| Clinical Research of the Ozarks | Warrensburg | Missouri | 64093 | United States |
| Clinical Research Group of Montana | Bozeman | Montana | 59718 | United States |
| The Asthma and Allergy Center, PC | Bellevue | Nebraska | 68123 | United States |
| Boys Town National Research Hospital | Boys Town | Nebraska | 68010 | United States |
| Atlantic Research Center LLC | Ocean City | New Jersey | 07712 | United States |
| Island Medical Research P.C. | Rockville Centre | New York | 11570 | United States |
| Allergy and Asthma Center of NC, PA | High Point | North Carolina | 27262 | United States |
| Catalyst Medical Center | Fargo | North Dakota | 58103 | United States |
| Sterling Research Group Ltd | Cincinnati | Ohio | 45246 | United States |
| Toledo Center for Clinical Research | Sylvania | Ohio | 43560 | United States |
| Allergy, Asthma & Clinical Research Center | Oklahoma City | Oklahoma | 73120 | United States |
| Amy Darter, MD | Oklahoma City | Oklahoma | 73131 | United States |
| Cyn3rgy Research | Gresham | Oregon | 97030 | United States |
| Baker Allergy Asthma and Dermatolgy Research Center, LLC | Lake Oswego | Oregon | 97035 | United States |
| Clinical Research Institute of Southern Oregon, PC | Medford | Oregon | 97504 | United States |
| Allergy Associates Research Center | Portland | Oregon | 97202 | United States |
| Valley Clinical Research Center | Bethlehem | Pennsylvania | 18020 | United States |
| Asthma and Allergy Research Associates | Upland | Pennsylvania | 19013 | United States |
| National Allergy, Ashtma, and Urticaria Centers of Charleston, PA | North Charleston | South Carolina | 29406 | United States |
| Isis Clinical Research LLC | Austin | Texas | 78731 | United States |
| Sirius Clinical Research | Austin | Texas | 787 | United States |
| TTS Research | Boerne | Texas | 78006 | United States |
| Pharmaceutical Research and Consulting, Inc. | Dallas | Texas | 75231 | United States |
| Western Sky Medical Research | El Paso | Texas | 79903 | United States |
| Kerrville Research Associates | Kerrville | Texas | 78028 | United States |
| Central Texas Health Research | New Braunfels | Texas | 78130 | United States |
| Sylvana Research Associates | San Antonio | Texas | 78229 | United States |
| Allergy and Asthma Research Institute | Waco | Texas | 76712 | United States |
| J. Lewis Research Inc. | Salt Lake City | Utah | 84109 | United States |
| J. Lewis Research Inc. | Salt Lake City | Utah | 84121 | United States |
| J. Lewis Research Inc. | South Jordan | Utah | 84095 | United States |
| PI-Coor Clinical Research | Burke | Virginia | 22015 | United States |
| Clinical Research Partners, LLC | Henrico | Virginia | 23233 | United States |
| ASTHMA, Inc. | Seattle | Washington | 98105 | United States |
| FG002 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo: placebo - one dose per nostril |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 0-6 |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 0 -6 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 0 -6 |
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| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 0 -12 |
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| 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. | The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication. | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 0 -12 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 0 -6 |
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| 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. | The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication. | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 0 -12 |
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| 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. | The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication. | Posted | Number | Number of Days | Weeks 0 -6 |
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| Secondary | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Posted | Number | participants | Weeks 0 -12 |
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| Secondary | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Posted | Number | percentage of subjects | Weeks 0 -12 |
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| Secondary | Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | Posted | Number | participants | Weeks 0 -12 |
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| Secondary | Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | Posted | Number | percentage of subjects | Weeks 0 -12 |
|
|
0-12 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo: placebo - one dose per nostril | 1 | 283 | 83 | 283 | ||
| EG001 | 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 | 1 | 282 | 95 | 282 | ||
| EG002 | 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 | 2 | 281 | 85 | 281 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NEUTROPENIA | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| APPENDICITIS | Infections and infestations | Systematic Assessment |
| ||
| HERPES ZOSTER | Infections and infestations | Systematic Assessment |
| ||
| INFLUENZA | Infections and infestations | Systematic Assessment |
| ||
| PNEUMONIA VIRAL | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PYREXIA | General disorders | Systematic Assessment |
| ||
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Systematic Assessment |
| ||
| HEADACHE | Nervous system disorders | Systematic Assessment |
| ||
| COUGH | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Respiratory Medical Director | Sunovion | 1-866-503-6351 |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| No |
| Superiority or Other |
| 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). | Bonferroni-based gatekeeping method | Bonferroni-based gatekeeping method was used for multiple comparison adjustment. | <0.05 | Multiple comparisons were adjusted for the primary and key secondary endpoints | LS Means with adjusted p-values. | 0.47 | No | Superiority or Other |
| 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 |
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ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily |
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ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily |
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|
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
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ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily |
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