A Double-Blind, Randomized, Parallel-Group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination GSP 301 Nasal Spray (NS) Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators) in Subjects (Aged 12 Years and Older) With Seasonal Allergic Rhinitis (SAR)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,180
- 试验地点
- 37
- 主要终点
- Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.
研究概览
简要总结
Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment
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
- •Aged 12 years and older inclusive of either sex.
- •Documented clinical history of SAR (for at least 2 years preceding the Screening Visit [Visit 1]) with exacerbations (clinical evidence of active symptoms) during the spring allergy season (tree/grass pollen)
- •A 12-hour reflective TNSS ≥ 8 out of a possible 12 and a congestion score of ≥ 2 for the AM assessment at the Screening Visit (Visit 1).
排除标准
- •Pregnant or lactating women.
- •Plans to travel outside the known pollen area for the investigative site for > 24 hours during the last 7 days of run in period.
- •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
研究组 & 干预措施
GSP 301 NS
干预措施: GSP 301 NS (Drug)
Olopatadine HCl NS
干预措施: Olopatadine HCl NS (Drug)
Mometasone furoate NS
干预措施: Mometasone furoate NS (Drug)
GSP 301 Placebo NS
干预措施: GSP 301 Placebo NS (Drug)
结局指标
主要结局
Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.
时间窗: 14 days
Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging 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