Comparison of Seasonal Allergic Rhinitis Treatment With 2 Antihistamines Used in Combination With Intranasal Corticosteroid
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline
研究概览
简要总结
The purpose of this study is to compare the efficacy of Olopatadine Nasal Spray with Azelastine Nasal Spray when treatments are utilized in conjunction with Fluticasone Nasal Spray for the treatment 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
- Triple (Participant, Care Provider, 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
- •Able to provide consent/assent
- •History of spring/summer allergic rhinitis
- •Positive skin prick and/or intradermal test
- •Absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations
- •Non-pregnant (where applicable)
- •Able to complete daily diary
排除标准
- •Concurrent disease such as rhinitis medicamentosa or large obstructive nasal polyps
- •History of current chronic sinusitis
- •Use of anti-allergy immunotherapy, corticosteroids, chronic use of long acting antihistamines
- •History of severe, unstable, or uncontrolled cardiovascular, hepatic, renal and/or other diseases/illnesses
- •History or evidence of nasolacrimal drainage system malfunction
研究组 & 干预措施
Olopatadine HCl Nasal Spray, 0.6%
干预措施: Olopatadine HCl Nasal Spray, 0.6% (Drug)
Azelastine HCl Nasal Spray, 0.1%
干预措施: Azelastine HCl Nasal Spray, 0.1% (Drug)
结局指标
主要结局
Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline
时间窗: 14 days minus baseline
Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12 . Reflective scores were assessed from the hour since the last dose of study medication.
Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline
时间窗: 14 days minus baseline
Responses to patient-completed diaries for reflective Total Ocular Symptom Scores (rTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9 . Reflective scores were assessed from the hour since the last dose of study medication.
Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline
时间窗: 14 days minus baseline
Responses to patient-completed diaries for instantaneous Total Nasal Symptom Scores (iTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12 . Instantaneous scores were assessed at the time of daily dosing.
Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline
时间窗: 14 days minus baseline
Responses to patient-completed diaries for instantaneous Total Ocular Symptom Scores (iTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9 . Instantaneous scores were assessed at the time of daily dosing.
次要结局
未报告次要终点