Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis: Double Blinded, Randomized, Placebo Controlled, Parallel Designed, Multi-centered, Phase III Study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
245
Pranlukast 10% dry syrup, b.i.d.
Placebo dry syrup, b.i.d
Seoul National University Hodpital
Seoul, South Korea
Mean change from baseline in NIS(Nasal Index Score) over the 4-week treatment period
Evaluation : from baseline(1-week prior to treatment)over the 4-week treatment(1-week prior to patients' last visit). NIS : Sum of 4 individual scores for Nasal congestion, Rhinorrhea, Sneezing, and Nasal itching, each rated by patients daily on a 4-point scale \[Score 0(best) to 3(worst)\].
Time frame: 4 week treatment period (from baseline through the end of week 4)
Assessing improvement of symptom by physician
Time frame: from baseline through the end of week 4
Assessing improvement of symptom by patient
Time frame: from baseline through the end of week 4
Mean change of Individual NIS
Time frame: from baseline through the end of week 4
Ratio distribution of NIS at end of week 4
Percentage of each NIS score.
Time frame: from baseline through the end of week 4
Cure rate
Time frame: from baseline through the end of week 4
Cure rate for each symptom
Time frame: from baseline through the end of week 4
Use of rescue medication
Time frame: from baseline through the end of week 4
Change of Instantaneous NIS
Time frame: from baseline through the end of week 4
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