NCT00502775已完成4 期
A Comparison of Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine in the Treatment of Seasonal Allergic Rhinitis
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 680
- 试验地点
- 43
- 主要终点
- Mean Change From Baseline in the Nighttime Symptom Score (NSS)
研究概览
简要总结
The primary objective of the study is to compare nighttime symptom relief of fluticasone furoate nasal spray versus oral fexofenadine
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
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
- •Informed consent
- •Otherwise healthy outpatient with mountain cedar allergy
- •Male or eligible female Females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control
- •Age 12 years or older at Visit 2
- •Diagnosis of seasonal allergic rhinitis (SAR) to mountain cedar
- •Adequate exposure to mountain cedar pollen
- •Ability to comply with study procedures
排除标准
- •Significant concomitant medical conditions
- •Use of intranasal corticosteroids within four weeks prior to Visit 1; use of inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) within eight weeks prior to Visit
- •Use of other allergy medications within specific timeframes relative to Visit 1
- •Use of other medications that may affect allergic rhinitis or its symptoms
- •Use of immunosuppressive medications eight weeks prior to screening and during the study
- •Immunotherapy patients who are not stable on current dose
- •Use of any medications that significantly alters the pharmacokinetics of fluticasone furoate or fexofenadine
- •Allergy/Intolerance to corticosteroids, antihistamines, or any excipients in the two products
- •Use of contact lenses
- •Recent clinical trial/experimental medication experience within 30 days of Visit 1
- •Subject previously failed the 21-day screen period or failed to complete the treatment period
- •Positive or inconclusive pregnancy test or female who is breastfeeding
- •Employee or relative affiliation with investigational site
- •Current tobacco use
- •Active chickenpox or measles or exposure in the last 3 weeks
结局指标
主要结局
Mean Change From Baseline in the Nighttime Symptom Score (NSS)
时间窗: Baseline and Weeks 1-2
Questions include: 1. Nasal congestion on awakening (Score: 0=none, 1=mild, 2=moderate, 3=severe); 2. Difficulty going to sleep (Score: 0=not at all, 1=little, 2=moderately, 3=very); 3. Nighttime awakenings (Score: 0=not at all, 1=once, 2=more than once, 3=felt like awake all night). The sum of the ratings for the three items comprises the NSS.
次要结局
- Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)(Baseline and Weeks 1-2)
- Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)(Baseline and Weeks 1-2)
- Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)(Baseline and Weeks 1-2)
- Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)(Baseline and Weeks 1-2)
- Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)(Baseline and Weeks 1-2)
- Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)(Baseline and Weeks 1-2)
- Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)(Baseline and Weeks 1-2)
- Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)(Baseline and Weeks 1-2)
- Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)(Baseline, Day 15 or if Early Withdrawal Day)
- Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)(Baseline and Weeks 1-2)
- Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)(Baseline and Weeks 1-2)
研究者
研究点 (43)
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