This study aims to compare the efficacy and safety of DW1807 and DW1807-R2 in patients with perennial allergic rhinitis and comorbid asthma. The primary objective is to demonstrate the superiority of DW1807 over DW1807-R2 in improving the reflective total nasal symptom score (rTNSS) after 4 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
274
1. DW1807 Once daily with water regardless of meals without chewing or crushing for up to 4 weeks 2. DW1807-R2 placebo Once daily with water regardless of meals without chewing or crushing for up to 4 weeks
1. DW1807 placebo Once daily with water regardless of meals without chewing or crushing for up to 4 weeks 2. DW1807-R2 Once daily with water regardless of meals without chewing or crushing for up to 4 weeks
Konkuk University Medical Center
Seoul, South Korea
RECRUITINGThe mean change in reflective Total Nasal Symptom Score (rTNSS)
Time frame: During the last 2 weeks of the treatment period (i.e., Weeks 3 to 4 of investigational product administration
The mean change from baseline in reflective Total Nasal Symptom Score (rTNSS)
Time frame: During the first two weeks of the treatment period (Weeks 1 through 2 of investigational product administration).
The mean change from baseline in instantaneous Total Nasal Symptom Score (iTNSS)
Time frame: During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.
The mean change from baseline in Daytime Nasal Symptom Score (DNSS)
Time frame: During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.
The mean change from baseline in Nighttime Nasal Symptom Score (NNSS)
Time frame: During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.
The mean change from baseline in Nighttime Symptom Score (NSS)
Time frame: During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.
The mean change from baseline in [Insert Specific Symptom or Score]
Time frame: During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.
The Global Evaluation of Allergic Rhinitis (GEAR) assessed independently by both the investigator and the subject
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Time frame: At Week 4 of investigational product administration.