A Randomized, Double-blind, Active-controlled, Parallel, Multi-center, Phase 3 Trial to Compare and Evaluate the Efficacy and Safety of DW1807 and DW1807-R2 in Perennial Allergic Rhinitis Patients With Asthma
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.
⁃ \<Screening Visit\>
• Male or female adults aged 19 years or older.
• Individuals with a confirmed history or treatment record of perennial allergic rhinitis for at least 2 years at the time of screening.
• 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.).
• Individuals diagnosed with asthma classified as Step 2 to Step 4.
• Individuals who voluntarily provide written informed consent to participate in this clinical trial.
⁃ \<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.
• 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).
• Subjects with medication compliance of ≥80% during the 7-day run-in period.