Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,388
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)
研究概览
简要总结
A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6 to 11 years with a history of seasonal 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
- 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 or female; minimum of 6 years of age and less than 12 years
- •2 year history of seasonal allergic rhinitis
排除标准
- •Concurrent disease that might interfere with the investigation or evaluation of te study medication
- •Confirmed diagnosis of chronic rhinosinusitis within the last year
- •Asthma, with the exception of mild intermittent asthma
- •Anatomical nasal deformity
- •Nasal obstruction
- •Known non-responder to antihistamines for symptoms of Seasonal Allergic Rhinitis (SAR)
- •Chronic or intermittent use of of inhaled, oral, intramuscular intravenous corticosteroids ot topical steroids
- •Ocular disorder other that allergic conjunctivitis
研究组 & 干预措施
Olopatadine 0.6% 1 Spray
Olopatadine HCl 0.6% 1 spray per nostril twice daily
干预措施: Olopatadine Hydrochloride Nasal Spray 0.6% (Drug)
Vehicle 1 spray
Vehicle 1 spray per nostril twice daily
干预措施: Vehicle (Drug)
Olopatadine 0.6% 2 sprays
Olopatadine HCl 0.6% 2 sprays per nostril twice daily
干预措施: Olopatadine Hydrochloride Nasal Spray 0.6% (Drug)
Vehicle 2 sprays
Vehicle 2 sprays per nostril twice daily
干预措施: Vehicle (Drug)
结局指标
主要结局
Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)
时间窗: Baseline through 2 weeks after randomization
Total Nasal Symptom Score comprised of scoring each of the following symptoms: runny nose, stuffy nose, itchy nose, and sneezing. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 4 individual symptom scores were then added together for a total nasal symptom score. The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 4 individual scores averaged across all days.
次要结局
- Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)(Baseline through 2 weeks after randomization)