NCT01076439撤回4 期
A Pilot Study Evaluating the Onset of Action of Fluticasone Furoate Nasal Spray and Olopatadine Nasal Spray Compared to Placebo Nasal Spray in Reducing Nasal Allergic Symptoms Following Ragweed Exposure in the Allergen BioCube (ABC)
ORA, Inc.0 个研究点开始时间: 2010年2月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- Nasal Signs and Symptoms (TNSS)
研究概览
简要总结
The purpose of this study is to evaluate the onset of action of fluticasone furoate nasal spray compared to olopatadine nasal spray and placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after single dose administration and six consecutive days of treatment.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •provide written informed consent and signed HIPAA form;
- •be able and willing to follow all instructions and attend the study visits;
- •if female and of childbearing potential, be not pregnant, nursing or planning a pregnancy, be willing to submit a pregnancy test at visit 1 and at exit visit, and to use adequate method of birth control
- •have a positive history of seasonal allergic rhinitis to ragweed;
- •have a positive skin test reaction to ragweed of within the past 24 months;
- •manifest sufficient allergic rhinitis symptoms during ragweed exposure in the ABC
排除标准
- •manifest symptoms of clinically active allergic rhinitis at the start of Visit 1 or Visit 2;
- •known intolerance or allergy to antihistamines or corticosteroids;
- •have a compromised lung function at Visit 1;
- •have significant nasal anatomical deformities or any condition that does not allow subject to breathe through the nose (includes, but is not limited to: septal deviation, septal perforations, nasal polyps, rhinitis medicamentosa)
- •have had any nasal surgical intervention in the past;
- •have planned surgery (nasal, ocular or systemic) during the trial period or within 30 days thereafter;
- •use disallowed medications (topical, topical ophthalmic, systemic and/or injectable treatments and all anti-allergy therapies including prescription, over the counter or homeopathy, and over the counter sleeping aids) during the study or appropriate pre-study washout period
研究组 & 干预措施
Olopatadine Nasal Spray (Patanase)
Active Comparator
干预措施: Olopatadine Nasal Spray (Drug)
Fluticasone Furoate Nasal Spray (Veramyst)
Active Comparator
干预措施: Fluticasone Furoate Nasal Spray (Drug)
Saline Nasal Spray (Placebo)
Placebo Comparator
干预措施: Saline Nasal Spray (Drug)
结局指标
主要结局
Nasal Signs and Symptoms (TNSS)
时间窗: Evaluated by the subject pre-ABC exposure, every 15 minutes during all ragweed exposures in the ABC, and post-ABC exposure
TNSS (0-12 unit scale) is defined as the sum of the four nasal symptom scores recorded for nasal itching, sneezing, rhinorrhea and nasal congestion.
次要结局
- Peak Expiratory Flow Rate (PEFR)(Measured pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure)
- Peak Nasal Inspiratory Flow (PNIF)(Measured pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure)
- Headaches(Evaluated by the subject pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure)
研究者
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