NCT07168473招募中3 期
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
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- The mean change in reflective Total Nasal Symptom Score (rTNSS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •<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
- •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.
排除标准
- •<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.
研究组 & 干预措施
Experimental
Experimental
DW1807 & DW1807-R2 placebo
干预措施: Experimental (Drug)
Comparator
Active Comparator
DW1807 placebo & DW1807-R2
干预措施: Comparator (Drug)
结局指标
主要结局
The mean change in reflective Total Nasal Symptom Score (rTNSS)
时间窗: During the last 2 weeks of the treatment period (i.e., Weeks 3 to 4 of investigational product administration
次要结局
- 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)(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.)
研究者
研究点 (1)
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