NCT04670653撤回3 期
National, Multicenter, Randomized, Simple-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Magnólia Nasal Gel in the Treatment of Allergic Rhinitis in Participants With Age Greater Than or Equal to 12 Years.
EMS0 个研究点开始时间: 2022年8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
- 撤回
- 发起方
- 主要终点
- Change from baseline in the reflective total nasal symptom score (rESN) averaged over the entire treatment period.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Magnólia nasal gel in the treatment of moderate-severe persistent or moderate-severe intermittent 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
- Single (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
- •Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
- •Participants of both sexes, with age greater than or equal to 12 years;
- •Clinical diagnosis of moderate-severe persistent or moderate-severe intermittent allergic rhinitis, according to the ARIA classification;
- •Present the general status of rhinitis as moderate or severe;
- •Total nasal symptom score greater than or equal to 6 points, with congestion and one or more of the other symptoms present (itching, runny nose, and sneezing) with a score greater than or equal to 2 at the screening visit;
- •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;
- •History of alcohol abuse or illicit drug use;
- •Participation in a clinical trial in the year before this study;
- •Pregnancy or risk of pregnancy and lactating patients;
- •Known hypersensitivity to the formula components used during the clinical trial;
- •Participants who present other clinical forms of rhinitis, such as, but not restricted to medicated rhinitis, vasomotor and atrophic;
- •Participants dependent on decongestants (nasal or oral) or receiving allergen-specific immunotherapy;
- •Participants with suggestive signs of upper airways bacterial infection;
- •Participants with grade II or III septum deviation and/or presence of nasal polyps or other conditions that lead to nasal obstruction;
- •Concomitant chronic or intermittent use of decongestants, antihistamines, or corticosteroids by inhalation, oral, intramuscular, or intravenous;
- •Concomitant use of potent topical corticosteroids.
研究组 & 干预措施
MAGNÓLIA
Experimental
Two applications in each nostril, once a day.
干预措施: MAGNÓLIA NASAL GEL (Drug)
MOMETASONE FUROATE
Active Comparator
Two applications in each nostril, once a day.
干预措施: MOMETASONE FUROATE (Drug)
结局指标
主要结局
Change from baseline in the reflective total nasal symptom score (rESN) averaged over the entire treatment period.
时间窗: 4 weeks
The participant will answer the nasal symptom score (together with their parents or guardians, for participants with less than 18 years old) every 12 hours, in the participant's diary. The rESN will be the average of the two measurements of the day.
次要结局
- Incidence and severity of adverse events recorded during the study.(6 to 10 weeks)
研究者
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