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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | DW1807 & DW1807-R2 placebo |
|
| Comparator | Active Comparator | DW1807 placebo & DW1807-R2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The mean change in reflective Total Nasal Symptom Score (rTNSS) | During the last 2 weeks of the treatment period (i.e., Weeks 3 to 4 of investigational product administration |
| Measure | Description | Time Frame |
|---|---|---|
| The mean change from baseline in reflective Total Nasal Symptom Score (rTNSS) | 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) |
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Inclusion Criteria:
<Screening Visit>
<Randomization Visit>
Subjects who meet all of the following criteria based on self-assessed nasal symptom scores recorded in the subject diary during the 7-day run-in period.
â‘ Performed nasal symptom evaluations twice daily (morning and evening) on at least 4 days during the run-in period.
② Had an average daily Reflective Total Nasal Symptom Score (rTNSS) of ≥6 (maximum score: 12).
Subjects with medication compliance of ≥80% during the 7-day run-in period.
Exclusion Criteria:
<A. Disease and Medical History-Related Exclusion Criteria>
Individuals diagnosed with non-allergic rhinitis of other causes.
Individuals with a documented acute exacerbation of asthma within 12 weeks prior to screening.
Individuals diagnosed with pulmonary diseases other than asthma.
Individuals diagnosed with the following types of sinusitis:
â‘ Acute sinusitis within 4 weeks prior to screening.
â‘¡ Clinically significant chronic sinusitis, as determined by the investigator.
Individuals with nasal polyps or other clinically significant nasal structural abnormalities.
Individuals who have undergone nasal or perinasal surgery within 12 weeks prior to screening.
Individuals with a documented upper respiratory tract infection (including the common cold) or systemic infection within 3 weeks prior to screening.
<B. Concomitant Medication Use>
<C. Laboratory Criteria>
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jong-in Son | Contact | +82-2-2204-7053 | jonginson112@daewonpharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk University Medical Center | Recruiting | Seoul | South Korea |
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Double (Participant, Investigator)
| Comparator | Drug |
|
|
| 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) | 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) | 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) | 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] | 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 | At Week 4 of investigational product administration. |