EUCTR2015-004873-34-Outside-EU/EEA进行中（未招募）1 期
A Comparison of Fluticasone Furoate Nasal Spray (FFNS) versus OralFexofenadine in the Treatment of Seasonal Allergic Rhinitis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 680
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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
- •- Literate
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 140
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 996
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
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 1.
- •- Use of other allergy medications within specific timeframes elative 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
研究者
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