NCT01439815已完成4 期
A Single-Center, Randomized, Double-Masked, Placebo-Controlled Evaluation of the Efficacy of Flonase (Fluticasone Propionate Nasal Spray) Compared to Placebo Nasal Spray in the Allergen BioCube (ABC) Model
ORA, Inc.1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)
研究概览
简要总结
The purpose of this study is to evaluate the onset of action of fluticasone propionate nasal spray compared to placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after up to 14 days of at home dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, 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
- •known intolerance or allergy to antihistamines or corticosteroids;
- •have a compromised lung function at Visit 1;
- •develop a compromised lung function at Visits 2-6
- •have any presence of active sinus or nasal infection at any visit;
- •have experienced an acute upper or lower respiratory tract infection or acute sinusitis within 30 days of 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 a known history of glaucoma
- •have planned surgery (nasal, ocular or systemic) during the trial period or within 30 days thereafter;
- •inability or refusal to discontinue contact lens wear during all visits;
- •use disallowed medications during the study or appropriate pre-study washout period
研究组 & 干预措施
Placebo Nasal Spray
Placebo Comparator
Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
干预措施: Saline Nasal Spray (Drug)
Fluticasone Propionate
Active Comparator
Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
干预措施: Fluticasone Propionate Nasal Spray (Drug)
结局指标
主要结局
Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)
时间窗: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
The change in the total sum of the four symptoms (total nasal symptom scores - TNSS) ranging from 0 to 16 with higher score indicating a more severe reaction. The change in the TNSS score between Day 0 and Day 16 was analyzed.
次要结局
- Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16(pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16)
- Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16(pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16)
- Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16(pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16)
- Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16(pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Dose Finding Study of Fluticasone Furoate Nasal Spray for Uncomplicated Acute RhinosinusitisSinusitis, AcuteNCT01018030GlaxoSmithKline741
撤回
4 期
An Allergen BioCube (ABC) Study Evaluating the Onset of Action of Fluticasone Furoate Nasal Spray and Olopatadine Nasal Spray Compared to PlaceboAllergic RhinitisNCT01076439ORA, Inc.
已完成
3 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Nasal Spray for 2 Weeks in Chinese Adult and Adolescent Subjects With Allergic RhinitisRhinitis, Allergic, PerennialAllergic RhinitisNCT01231464GlaxoSmithKline365
已完成
1 期
Effects of fluticasone nasal spray on clinical symptoms and serum IgENasal polypIRCT20140519017756N40Mashhad University of Medical Sciences34
已完成
3 期
Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Treatment of Seasonal Allergic Rhinitis (Study P05106)(COMPLETED)Seasonal Allergic RhinitisNCT00468312Organon and Co429