A Double-Blind, Randomized, Parallel-Group Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray in Pediatric Subjects (Aged 6 to Under 12 Years) 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
- 446
- 试验地点
- 32
- 主要终点
- Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score ( rTNSS) Over the 14-day Treatment Period
研究概览
简要总结
Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).
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
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged ≥6 to <12 years
- •Clinical history of SAR (at least 2 years) with exacerbations during the study season for the relevant seasonal allergen (e.g., tree/grass pollen)
- •Demonstrated sensitivity to at least 1 seasonal allergen through positive skin prick test within 12 months prior to screening
- •A 12-hour rTNSS value ≥6 out of a possible 12 for the morning assessment at screening
- •Signed informed consent/assent form (subject and parent/caregiver/legal guardian)
排除标准
- •Females of childbearing potential or pregnant
- •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.
- •History of anaphylaxis and/or other severe local reaction(s) to skin testing
- •History and evidence of acute or significant chronic sinusitis or chronic purulent post nasal 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
Fixed dose combination of olopatadine hydrochloride 665 μg and mometasone furoate 25 μg NS
干预措施: GSP 301 NS (Drug)
GSP 301 Placebo NS
GSP 301 Placebo nasal spray
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) Over the 14-day Treatment Period
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). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate, causes interference with activities of daily living and/or sleeping). Each of these four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching) of the rTNSS is rated on a scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). The four nasal symptoms of the rTNSS is summed. The total score of the rTNSS ranged from 0 to 12.
次要结局
- Change From Baseline in Average AM and PM Subject-reported 12-hour Instantaneous Total Nasal Symptom Score (iTNSS) Over the 14-day Treatment Period.(Baseline and day 14)
- Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Ocular Symptom Score (rTOSS) Over the 14-day Treatment Period.(Baseline and day 14)
- Change From Baseline in the Overall Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score on Day 15 (Visit 4)(Baseline and day 15)