A Patient Preference Evaluation Study of Fluticasone Furoate Nasal Spray and Fluticasone Propionate Aqueous Nasal Spray in Subject With Allergic Rhinitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
研究概览
简要总结
The objectives of this study are to evaluate and compare patient preference for FF (Fluticasone Furoate) and FP (Fluticasone Propionate Aqueous)nasal sprays in the treatment of allergic rhinitis following single-dose administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
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
- •allergic rhinitis
排除标准
- •clinical significant uncontrolled disease
- •Use of intranasal corticosteroids (<4 weeks of FP [branded or generic],<4 week exposure to FF, <4 weeks use of other INS)
- •Use of intranasal medications <1 week
- •Use of meds that significantly inhibit CYP4503A4
- •Use of perfume or oral rinse on study day
- •Allergy/intolerance to INS, antihistamines, or excipients
- •Positive pregnancy test or female who is breastfeeding
- •Affiliation with investigational site
研究组 & 干预措施
fluticasone propionate (FP)
200 micrograms (mcg); an aqueous suspension of microfine FP
干预措施: fluticasone propionate (FP) (Drug)
fluticasone furoate (FF)
110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF
干预措施: fluticasone furoate (FF) (Drug)
结局指标
主要结局
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
时间窗: Day 1
An overall preference questionnaire (OPQ) was used to evaluate participant's preference for nasal spray therapy for the given treatments. OPQ allows the responder three options, based on products attributes, i.e. preference for product 1 (FF 110 µg); preference for product 2 (FP 200 µg) and no preference. Three participant-related questionnaires were completed during the course of the study, including two attributes questionnaires : Immediate attributes questionnaire (IAQ) and delayed attributes questionnaire (DAQ). An OPQ was completed upon completion of the crossover dosing.
次要结局
- Number of Participants With Preference for Scent/Odor in IAQ and DAQ(Day 1)
- Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ(Day 1)
- Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ(Day 1)
- Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ(Day 1)
- Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ(Day 1)
- Number of Participants Reported Product Have an Immediate Taste in IAQ(Day 1)
- Number of Participants Satisfied With an Immediate Taste in IAQ(Day 1)
- Number of Participants Reported Product Have an After Taste in DAQ(Day 1)
- Number of Participants Satisfied With an After Taste in DAQ(Day 1)
- Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ(Day 1)
- Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ(Day 1)
- Number of Participants Reported Product Feel Soothing in IAQ and DAQ(Day 1)
- Number of Participants Reported Product Make Want to Sneeze in IAQ(Day 1)
- Number of Participants Satisfied With Product in DAQ(Day 1)
- Number of Participants Reported Nasal Irritation in DAQ(Day 1)
- Number of Participants Reported Nasal Irritation Bothersome in DAQ(Day 1)
- Number of Participants Comply With Product if Prescribed in DAQ(Day 1)