NCT05607446终止1 期
A Single-center, Randomized, Double-blind, Two-cycle, Two-way Crossover Phase Ib Study to Evaluate the Efficacy and Safety of TQC3564 Tablets in the Treatment of Persistent Allergic Rhinitis
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Total nasal symptom Score (TNSS)
研究概览
简要总结
A clinical study to evaluate the efficacy and safety of tqc3564 tablets in the treatment of persistent allergic rhinitis. A total of 24 patients will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18~65 years old, male or female;
- •Meet the clinical diagnostic criteria for allergic rhinitis, and the diagnosis is based on the "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2015, Tianjin)" issued by the Rhinology Group of the Otolaryngology Head and Neck Surgery Branch of the Chinese Medical Association:
- •Symptoms: sneezing 2 or more symptoms, such as watery mucus, nasal itching and nasal congestion, persist or accumulate for more than 1 hour per day, and may be accompanied by eye symptoms such as itching, watering and redness;
- •Signs: Pale and edema of the nasal mucosa is common. Nasal watery secretions;
- •Allergen test: at least one allergen SPT and/or serum-specific IgE positive (test results within 12 months before screening);
- •Female subjects of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum pregnancy test within 14 days before study enrollment , and must be non-lactating subjects; male subjects should agree to use contraception during the study period and for 6 months after the end of the study period.
- •The subjects voluntarily joined the study, signed the informed consent, and had good compliance.
排除标准
- •Patients with non-allergic rhinitis, such as drug-induced rhinitis, vasomotor rhinitis, non-allergic rhinitis eosinophilic rhinitis, etc.; patients with severe nasal septum deviation, sinusitis, nasal polyps, hypertrophic rhinitis Other nasal organic lesions;
- •In the nasal examination at the end of the screening period or the introduction period, there is any erosion of the nasal mucosa, septal ulcer or perforation of the nasal septum;
- •Those who have undergone sinus surgery within 3 months before the screening period or who have not fully healed the nasal wound;
- •The subject has uncontrolled diabetes mellitus, that is, fasting blood glucose (FBG) > 10mmol/L in the laboratory test during the screening period;
- •History of allergy to any study drug or similar chemical drugs (CRTh2 antagonists);
- •History of severe allergic reaction to any allergen, such as anaphylactic shock or life-threatening asthma, previous intubation, respiratory arrest, hospitalization for asthma or acute asthma attack within the past 3 months;
- •Those who were found to respond to placebo during the lead-in period (with rhinitis symptoms of moderate or above during the screening period, those with mild or no symptoms during the lead-in period, or baseline rTNSS mean <6 points were defined as placebo responders;
- •Women who are pregnant or breastfeeding, or who plan to become pregnant or breastfeeding during the study period;
- •Any subject deemed unsuitable for participation in this clinical study by the investigator.
研究组 & 干预措施
TQC3564 tablets
Experimental
Orally administer TQC3564 tablets for 14 days.
干预措施: TQC3564 tablets (Drug)
placebo tablets
Placebo Comparator
Orally administer placebo tablets for 14 days.
干预措施: Placebo tablets (Drug)
TQC3564 tablets + montelukast sodium tablets
Experimental
Orally administer TQC3546 tablets combined with Montelukast sodium tablets for 14 days.
干预措施: TQC3564 tablets, montelukast sodium tablets (Drug)
placebo tablets + montelukast sodium tablets
Placebo Comparator
Orally administer placebo tablets combined with Montelukast sodium tablets for 14 days.
干预措施: Placebo tablets, montelukast sodium tablets (Drug)
结局指标
主要结局
Total nasal symptom Score (TNSS)
时间窗: Baseline, Day 14
Change in the investigator-assessed total nasal symptom score (TNSS) from baseline to 14 days. TNSS was the sum score of 4 nasal symptoms with a minimum score of 0 units and a maximum score of 12 units, with higher score corresponding to increased nasal allergy symptoms.
次要结局
- Incidence of adverse events(Day 1-32)
- Total ocular symptom score(TOSS)(Baseline, Day 14)
- Rescue medication frequency(Day 1-32)
- Individual Total Nasal Symptom Score (TNSS)(Baseline, Day 14)
- Individual Total Ocular Symptom Score (TOSS)(Baseline, Day 14)
- Rescue medication proportion(Day 1-32)
- Daily symptoms score (dSS)(Baseline, Day 14)
研究者
研究点 (1)
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