Status:
RECRUITING
Study to Evaluate the Efficacy and Safety of DW1807 in Perennial Allergic Rhinitis Patients With Asthma
Lead Sponsor:
Daewon Pharmaceutical Co., Ltd.
Conditions:
Perennial Allergic Rhinitis Accompanied by Asthma
Eligibility:
All Genders
19+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- \<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.
Exclusion
- \<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:
- ① Acute sinusitis within 4 weeks prior to screening.
- ② 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\>
- Subjects who have initiated immunotherapy or changed the dosage within 4 weeks prior to the screening visit.
- Subjects who are on chronic use of medications that, in the opinion of the investigator, may interfere with the assessment of the investigational product's efficacy (e.g., tricyclic antidepressants).
- Subjects who are currently taking, or are expected to require during the study, any medications that are prohibited as per the protocol.
- \<C. Laboratory Criteria\>
- Subjects with serum AST (GOT) or ALT (GPT) levels \> 2 × the upper limit of normal (ULN) based on screening test results.
- Subjects with an estimated glomerular filtration rate (eGFR, calculated by CKD-EPI) \< 30 mL/min/1.73 m² based on screening test results.
Key Trial Info
Start Date :
September 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 18 2026
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT07168473
Start Date
September 9 2024
End Date
September 18 2026
Last Update
September 11 2025
Active Locations (1)
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1
Konkuk University Medical Center
Seoul, South Korea