Actively Recruiting
Study to Evaluate the Efficacy and Safety of DW1807 in Perennial Allergic Rhinitis Patients With Asthma
Led by Daewon Pharmaceutical Co., Ltd. · Updated on 2025-09-11
274
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Evaluate the Efficacy and Safety of DW1807 in Perennial Allergic Rhinitis Patients With Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults aged 19 years or older
- Confirmed history or treatment record of perennial allergic rhinitis for at least 2 years at screening
- Positive allergy skin prick test or serum allergen-specific IgE antibody test within 1 year prior to screening
- Documented allergy to at least one perennial allergen (e.g., house dust mites, cats, dogs, molds)
- Diagnosed with asthma classified as Step 2 to Step 4
- Provided written informed consent
- Completed nasal symptom evaluations twice daily on at least 4 days during a 7-day run-in period
- Average daily Reflective Total Nasal Symptom Score (rTNSS) of 6 or higher during the run-in period
- Medication compliance of 80% or higher during the 7-day run-in period
You will not qualify if you...
- Diagnosis of non-allergic rhinitis of other causes
- Acute exacerbation of asthma within 12 weeks prior to screening
- Pulmonary diseases other than asthma
- Acute sinusitis within 4 weeks prior to screening
- Clinically significant chronic sinusitis
- Nasal polyps or other significant nasal structural abnormalities
- Nasal or perinasal surgery within 12 weeks prior to screening
- Upper respiratory tract infection or systemic infection within 3 weeks prior to screening
- Initiated immunotherapy or changed dosage within 4 weeks prior to screening
- Chronic use of medications that may interfere with study assessments
- Use or expected need for prohibited medications during the study
- Serum AST (GOT) or ALT (GPT) levels greater than 2 times the upper limit of normal
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Konkuk University Medical Center
Seoul, South Korea
Actively Recruiting
Research Team
J
Jong-in Son
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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