Perennial Allergic Rhinitis Accompanied by Asthma
Conditions
Brief summary
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.
Interventions
DRUGExperimental
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
DRUGComparator
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
Sponsors
Daewon Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double (Participant, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\<Screening Visit\> 1. Male or female adults aged 19 years or older. 2. Individuals with a confirmed history or treatment record of perennial allergic rhinitis for at least 2 years at the time of screening. 3. Individuals who have a positive result on an allergy skin prick test or serum allergen-specific IgE antibody test (e.g., MAST or ImmunoCAP) conducted within 1 year prior to screening, and have a documented history of allergy to at least one perennial allergen (e.g., house dust mites, cats, dogs, molds, etc.). 4. Individuals diagnosed with asthma classified as Step 2 to Step 4. 5. Individuals who voluntarily provide written informed consent to participate in this clinical trial. \<Randomization Visit\> 1. 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. ① 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). 2. Subjects with medication compliance of ≥80% during the 7-day run-in period.
Exclusion criteria
\<A. Disease and Medical History-Related
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| The mean change from baseline in instantaneous Total Nasal Symptom Score (iTNSS) | 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 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 [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. |
| 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. |
Countries
South Korea
Contacts
Primary ContactJong-in Son
Outcome results
None listed