NCT07835074尚未招募3 期
A Phase 3, Multicenter, Double-blind, Randomized, Parallel-group Study to Evaluate the Efficacy and Safety of DEP114 in the Treatment of Acute Exacerbation of Persistent Allergic Rhinitis in Children Aged 6 to Less Than 12 Years.
EMS0 个研究点目标入组 316 人开始时间: 2027年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 316
- 主要终点
- Absolute change in the Total Nasal Symptom Score (TNSS) for nasal congestion, rhinorrhea, nasal itching, and sneezing, measured 5 days after treatment initiation (TNSS₀-₅).
研究概览
简要总结
The goal of this clinical trial is to learn whether DEP114 is effective in treating acute exacerbations of persistent allergic rhinitis in children aged 6 to less than 12 years. The study will also evaluate the safety of DEP114.
Participants will:
- Take DEP114 or desloratadine once daily for 5 days (up to a maximum of 7 days).
- Keep a diary of their symptoms.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to confirm voluntary participation and agreement with all study objectives by signing and dating the Informed Assent Form (IAF), with the participant's parent(s) or legal guardian(s) signing the Informed Consent Form (ICF);
- •Age ≥ 6 years and < 12 years on the date the IAF is signed and the ICF is signed by the parent(s) or legal guardian(s);
- •Diagnosis of persistent allergic rhinitis (PAR) according to the Allergic Rhinitis and its Impact on Asthma (ARIA) criteria, with severe exacerbation;
- •Evidence of sensitization to aeroallergens confirmed by a positive skin prick test and/or the presence of specific serum IgE;
- •Nasal congestion severity score ≥ 2 points;
- •Total Nasal Symptom Score (TNSS) ≥ 8 points.
排除标准
- •Use of prednisolone or any other oral or parenteral corticosteroid within 7 days before enrollment;
- •Use of topical or oral decongestants within 3 days before randomization;
- •Participants receiving allergen immunotherapy;
- •Participants with documented clinical evidence of significant acute or chronic sinusitis, in the opinion of the investigator, at the screening visit;
- •Participants who have not responded to loratadine or desloratadine treatment;
- •Use of antibiotics or an indication for antibiotic therapy at the screening visit;
- •Use of desmopressin;
- •Presence of adenoidal hypertrophy or known obstructive anatomical abnormalities (e.g., septal deviation) that may be responsible for nasal obstruction, in the opinion of the investigator;
- •Diagnosis of other forms of rhinitis, including but not limited to idiopathic rhinitis (formerly referred to as vasomotor rhinitis), infectious rhinitis (including viral rhinitis), food-induced rhinitis, hormonal rhinitis, drug-induced rhinitis, atrophic rhinitis, or non-allergic eosinophilic rhinitis (NARES);
- •Diagnosis of uncontrolled asthma;
- •Use of inhaled corticosteroids for indications other than asthma maintenance therapy;
- •History of seizures;
- •Presence of systemic fungal infection;
- •Presence of any uncontrolled infection;
- •Any clinical finding (medical history, physical examination, or laboratory abnormality) that, in the investigator's opinion, may place the participant at risk or interfere with participation in the study, including uncontrolled chronic disease(s);
- •Participants who are pregnant, breastfeeding, or post-menarche females of childbearing potential who are not using a reliable method of contraception;
- •Known allergy or hypersensitivity to any component of the study medications;
- •Current history of cancer and/or treatment for cancer within the previous 5 years;
- •Participation in another clinical trial within the previous 12 months, unless the investigator determines that participation may provide a direct benefit to the participant.
研究组 & 干预措施
DEP114
Experimental
The participants must take 5 mL per day
干预措施: DEP114 (Drug)
Desloratadine
Active Comparator
The participants must take 5 mL per day
干预措施: Desloratadine (Drug)
结局指标
主要结局
Absolute change in the Total Nasal Symptom Score (TNSS) for nasal congestion, rhinorrhea, nasal itching, and sneezing, measured 5 days after treatment initiation (TNSS₀-₅).
时间窗: Day 5 after treatment initiation
The Total Nasal Symptom Score (TNSS) is the sum of the severity scores for each nasal symptom assessed (nasal congestion, rhinorrhea, nasal itching, and sneezing) over the previous 24 hours. The severity of each symptom is evaluated using a 4-point categorical scale (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The total score ranges from 0 to 12 points, with higher scores indicating more severe nasal symptoms and a worse clinical condition. Negative changes from baseline indicate improvement in symptoms.
次要结局
- Overall improvement of nasal symptoms throughout the treatment period.(Day 5 after treatment initiation)
- Overall improvement of nasal symptoms 3 days after treatment initiation.(Day 3 after treatment initiation)
- Change From Baseline in Nasal Congestion Severity Assessed by the Nasal Congestion Severity Score (NCSS) Throughout the Treatment Period(From treatment initiation through Day 5 of treatment)
- Distribution of Participants by Rhinorrhea Severity Category Using the TNSS Rhinorrhea Item at Days 3 and 5(3 and 5 days after treatment initiation)
- Improvement in Nasal Itching Severity Assessed by the Total Nasal Symptom Score (TNSS) at Days 3 and 5 After Treatment Initiation(Day 3 and Day 5 after treatment initiation)
- Improvement in Sneezing Severity Assessed by the Total Nasal Symptom Score (TNSS) at Days 3 and 5 After Treatment Initiation(Day 3 and Day 5 after treatment initiation)
- Global Assessment of Treatment by the Participant's Caregiver at Day 5 After Treatment Initiation(Day 5 after treatment initiation)
- Investigator Global Assessment of Treatment at Day 5(Day 5 after treatment initiation)
研究者
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