NCT05684380尚未招募3 期
National, Multicenter, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of MAZ-101 in the Treatment of Persistent Allergic Rhinitis (PER)
EMS0 个研究点目标入组 514 人开始时间: 2024年9月最近更新:
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
- 514
- 主要终点
- Change from baseline in AM+PM rTNSS (reflective total nasal symptoms score).
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of MAZ-101 in the treatment of moderate-severe persistent allergic rhinitis.
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)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants of both sexes, with age greater than or equal to 12 years;
- •Clinical diagnosis of moderate-severe persistent for at least 1 year;
- •Screening Visit: A 12-hour reflective TNSS ≥ 8 out of a possible 12 and a congestion score of 2 or 3;
- •Randomization Visit: A 12-hour reflective TNSS (AM or PM) ≥ 8 on 3 separate symptoms assessments during the Lead-in Period; an AM or PM 12-hour reflective nasal congestion score of 2 or 3 must have been recorded on 3 separate symptom assessments;
- •Present skin sensitization test to at least one aeroallergen.
排除标准
- •Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
- •Other clinical forms of rhinitis;
- •Subjects receiving immunotherapy;
- •Presence of nasal polyposis;
- •Patients with severe arterial hypertension, severe coronary diseases, cardiac arrhythmias, glaucoma, ocular herpes simplex, cataracts, hyperthyroidism;
- •Asthma sufferers; respiratory tract infections and lung disease, including chronic obstructive pulmonary disease (COPD);
- •Presence of grade II or III septal deviation and/or presence of nasal polyps or other conditions that determine nasal obstruction;
- •Concomitant chronic or intermittent use of decongestants and/or antihistamines and/or inhaled, oral, intramuscular, intravenous or potent topical corticosteroids;
- •Participants using monoamine oxidase inhibitors (MAOIs);
- •Participants with known allergy or hypersensitivity to the components of the drugs used during the clinical trial;
- •History of alcohol abuse or illicit drug use;
- •Pregnancy or risk of pregnancy and lactating patients;
研究组 & 干预措施
MAZ-101
Experimental
One applications in each nostril, twice a day.
干预措施: MAZ-101association (Drug)
DYMISTA®
Active Comparator
One applications in each nostril, twice a day.
干预措施: DYMISTA® (Drug)
结局指标
主要结局
Change from baseline in AM+PM rTNSS (reflective total nasal symptoms score).
时间窗: 28 days.
Change from baseline in 12-hour reflective total nasal symptom score (rTNSS) consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary for the entire 28 day study period. The measurement scale is 0 to 24 so that the higher the number the worse the symptom.
次要结局
- Change from baseline in AM + PM: rTNSS (reflective total nasal symptoms score) plus rTOSS (reflective total ocular symptom score).(28 days.)
- Change from baseline in AM+PM rTOSS (reflective total ocular symptom score).(28 days.)
- Change from baseline in reflective individual nasal symptom scores.(28 days.)
- Change from baseline in the Rhinoconjunctivitis Quality of Life Questionnaire for adults (RQLQ) or Rhinoconjunctivitis Quality of Life Questionnaire for adolescents (AdolRQLQ).(28 days.)
- Change from baseline in reflective individual ocular symptom scores.(28 days.)
- Number of days without nasal symptoms(28 days.)
研究者
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