Study objective is to verify the superiority of CTZ DS to the placebo groups in the change of total nasal symptom score (TNSS) over the total treatment period from the score of the baseline assessment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Enrollment
239
GSK Investigational Site
Chiba, Japan
Change in the total nasal symptom score (TNSS) during the total treatment period from the baseline
TNSS is a sum of the nasal symptom score for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The Baseline value is defined as the average TNSS over the last 3 consecutive days prior to Day 1. For total treatment period, the average TNSS for each participant was calculated using available diary data from the total treatment period, taking the average of non-missing data during the period. Change from Baseline was calculated as the score at Baseline minus the mean score for the total treatment period.
Time frame: From Baseline to Day 14
Changes in TNSS on the first and the second weeks of the treatment period from the baseline
TNSS is a sum of the nasal symptom score for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The Baseline value is defined as the average TNSS over the last 3 consecutive days prior to Day 1. For total treatment period, the average TNSS for each participant was calculated using available diary data from the total treatment period, taking the average of non-missing data during the period. Change from Baseline was calculated as the score at Baseline minus the mean score at Week 1 and Week 2.
Time frame: From Baseline to Day 7 and Day 14
Mean scores for each nasal symptom and the time-course changes for the scores
Each nasal symptom score for sneezing, rhinorrhea, nasal congestion and nasal itching is scored on a scale from 0 to 3; the larger score indicates more severe symptoms. The parent/guardian or the participant scored nasal symptoms every day.
Time frame: From Baseline to Day 14
Time-course changes in a total of daily mean nasal symptom scores (TDNSS)
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GSK Investigational Site
Fukuoka, Japan
GSK Investigational Site
Fukuoka, Japan
GSK Investigational Site
Fukuoka, Japan
GSK Investigational Site
Hokkaido, Japan
GSK Investigational Site
Hokkaido, Japan
GSK Investigational Site
Hokkaido, Japan
GSK Investigational Site
Hokkaido, Japan
GSK Investigational Site
Hokkaido, Japan
GSK Investigational Site
Hokkaido, Japan
...and 18 more locations
TDNSS is a sum of the daily nasal symptom score for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is score on a scale from 0 to 3; the range of sums for TDNSS is 0 to 12; a larger score indicates more severe symptoms.
Time frame: From Baseline to Day 14
Investigator global improvement rating on the first day of Treatment Week 2 (Day 8) and the final observation day (Day 15 ) or at discontinuation (DC)
The investigator evaluated the participant's improvement rating (defined as improvement in the symptoms of rhinitis compared with Baseline), using the following 5 categories: significantly improved, moderately improved, mildly improved, unchanged, and worsened.
Time frame: Day 8 and Day 15 or DC
Participant global improvement rating on the first day of Treatment Week 2 (Day 8) and the final observation day (Day 15) or at DC
The participant's parent/guardian or the participant evaluated the participant's improvement rating (defined as improvement in the symptoms of rhinitis compared with Baseline), using the following 7 categories: significantly improved, improved, slightly improved, unchanged, slightly worsened, worsened, and significantly worsened.
Time frame: Day 8 and Day 15 or DC
Changes in each rhinoscopy finding (swelling and color of inferior conchal mucosa and aqueous secretion volume (ASV)) on first day of Treatment Week 1 (Day 1), the first day of Treatment Week 2 (Day 8) and the final observation day (Day 15) or at DC
Rhinoscopy was assessed by the investigator by scoring swelling of inferior conchal mucosa scored as 0 (none), 1 (possible to see center of the middle turbinate), 2 (between 1 and 3), or 3 (impossible to see middle turbinate); color of inferior conchal mucosa scored as 0 (normal), 1 (pink), 2 (red), or 3 (pale); aqueous secretion volume (vol) scored as 0 (none), 1 (small amount adhered), 2 (between 1 and 3), or 3 (filled).
Time frame: Day 1, Day 8 and Day 15 or DC