This is a 2-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-old diagnosed with SAR.
This is a 2-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-old diagnosed with SAR. This study will consist of the following: Screening, Single-blind Placebo Run-in period, Double-blind Treatment period (during this period, subjects will be randomized to double-blind treatment with either ciclesonide nasal aerosol 37 mcg or 74 mcg or placebo for 2 weeks of treatment) and Follow-up. The total duration of subject participation will be approximately 2 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
847
ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
Placebo - one actuation per nostril
Change From Baseline in Average Daily Subject Reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-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 two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Weeks 0 - 2
Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-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 two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Weeks 0 - 2
Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Ocular Symptom Scores (rTOSS) Over the 2-week Double-blind Treatment Period.
TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
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Arkansas Pediatric Clinic
Little Rock, Arkansas, United States
San Jose Multispecialty Medical Group, Inc
Baldwin Park, California, United States
WCCT Global, LLC
Costa Mesa, California, United States
Premier Health Research Center
Downey, California, United States
Allergy, Asthma, Brochitis and Immunology Assoc Medical Group
Fountain Valley, California, United States
Pediatric Care Medical Group, Inc.
Huntington Beach, California, United States
Pediatric Care Medical Group
Huntington Beach, California, United States
Allergy and Asthma Associates of Southern California
Mission Viejo, California, United States
CHOC, PSF, AMC, Division of Allergy, Asthma, and Immunology
Orange, California, United States
Center for Clinical Trials, LLC
Paramount, California, United States
...and 56 more locations
Time frame: Weeks 0 - 2
Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the 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 and the individual domain scores are the means of the items in those domains.
Time frame: Weeks 0 - 2
Change From Baseline in Average Daily Subject Reported AM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions assessed in the AM. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe in the AM. 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 two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time frame: Weeks 0 - 2
Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Ocular Symptom Scores (iTOSS) Over the 2-week Double-blind Treatment Period.
TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement
Time frame: Weeks 0 - 2
Time to Maximal Effect in the AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period
The time to maximal effect, defined as the number of days until the first treatment day on which the estimated difference between ciclesonide nasal aerosol and placebo was at least 90% of the largest estimated difference, was based on the analyses of change from baseline in the average of AM and PM rTNSS scores for each day. The time to achieve at least 90% of these estimated differences is presented.
Time frame: Weeks 0 - 2
Number of Subjects Experiencing Treatment-emergent AEs
Treatment-Emergent Adverse Events Occurring in ≥ 2% of Subjects in Any Treatment Group (ITT Population)
Time frame: Weeks 0 - 3
Percentage of Subjects Experiencing Treatment-emergent AEs
Treatment-Emergent Adverse Events Occurring in ≥ 2% of Subjects in Any Treatment Group (ITT Population)
Time frame: Weeks 0 - 3
Treatment-emergent AEs Causing Study Medication Discontinuation
Time frame: Weeks 0 - 3
Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
Time frame: Weeks 0 - 3
Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
Time frame: Weeks 0 - 3