A Double-Blind, Randomized, Parallel-Group Seasonal Allergic Rhinitis (SAR) Study to Evaluate the Efficacy, Safety and Tolerability of GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Olopatadine Hydrochloride Nasal Spray and Mometasone Furoate Nasal Spray) in Adult and Adolescent Subjects (12 Years of Age and Older)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,176
- 试验地点
- 43
- 主要终点
- Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS)
研究概览
简要总结
Study to evaluate the efficacy, safety and tolerability of GSP 301 NS compared with placebo NS and individual monotherapy formulations for the treatment of Seasonal Allergic Rhinitis (subjects 12 years of age and older)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Males and non-pregnant females who are 12 years of age and older.
- •Documented clinical history of SAR (for at least 2 years preceding the Screening Visit [Visit 1]) with exacerbations (clinical evidence of active symptoms) for the relevant seasonal allergen during the Fall or mountain cedar allergy seasons (e.g., ragweed or mountain cedar pollen)
- •A 12-hour rTNSS ≥8 out of a possible 12 and a congestion score ≥2 for the AM assessment at the Screening Visit (Visit 1).
排除标准
- •Pregnant or lactating women.
- •History of anaphylaxis and/or other severe local reaction(s) to skin testing.
- •History of positive test for HIV, Hepatitis B or Hepatitis C infection.
- •Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
- •Subjects with an active pulmonary disorder or infection.
- •Subjects with posterior subcapsular cataracts or glaucoma
- •Plans to travel outside the known pollen area for the investigational site for 24 hours or longer during the last 7 days of the run-in period.
研究组 & 干预措施
GSP 301 NS
干预措施: GSP 301 NS (Drug)
GOM-NS
干预措施: GOM-NS (Drug)
GMM-2 NS
干预措施: GMM-2 NS (Drug)
GSP 301 placebo NS
干预措施: GSP 301 placebo NS (Drug)
结局指标
主要结局
Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS)
时间窗: Baseline and day 14
The Reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Symptom scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).
次要结局
未报告次要终点