NCT00783458已完成4 期
A Preference Evaluation of Nasonex® Nasal Spray (Unscented) vs. Flonase® Nasal Spray (Scented) in Subjects With Symptomatic Allergic Rhinitis (AR) - Single-Dose Cross-over
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Overall product preference based on subjects' answer to the question "which product do you prefer overall"
研究概览
简要总结
This was a one-day single dose trial conducted to compare patient's preference for Nasonex® (mometasone) versus Flonase® nasal spray. Each patient was randomized to take one dose (2 sprays in each nostril) of Nasonex or Flonase. Thirty minutes later, each patient was to take one dose of the opposite medication. Questionnaires were given to each patient after each drug dose to evaluate patient product preference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have been 18-65 years of age, of either sex and any race.
- •Subject must have had symptomatic allergic rhinitis with a total nasal symptom (congestion, rhinorrhea, sneezing, itching) severity score of <6 but >2; congestion must have been <
- •Subject must have been free of any clinically significant disease (other than allergic rhinitis) that would interfere with study evaluations.
- •Subject must have understood and been able to adhere to the dosing and visit schedule.
排除标准
- •Subject had used any investigational product within 30 days prior to enrollment.
- •Subject was in a situation or condition that, in the opinion of the investigator, may have interfered with optimal participation in the study.
- •Subject was participating in any other clinical study(ies).
- •Subject was using any nasal lavage fluid or spray.
- •Subject was using any perfume during the study day.
- •Subject was using any oral rinse during the study day.
- •Subject had used topical or oral nasal decongestants in the past 1 week.
- •Subject had used a nasal corticosteroid in the previous 2 weeks.
- •Subject had anosmia or ageusia (absence of the sense of smell or taste).
- •Subject had been using medications which are associated with anosmia or ageusia in the 2 weeks prior to testing.
- •Subject had a respiratory infection in the 2 weeks prior to testing.
研究组 & 干预措施
Nasonex Followed by Flonase
Active Comparator
干预措施: Mometasone Furoate Nasal Spray (Drug)
Nasonex Followed by Flonase
Active Comparator
干预措施: fluticasone nasal spray (Drug)
Flonase Followed by Nasonex
Active Comparator
干预措施: Mometasone Furoate Nasal Spray (Drug)
Flonase Followed by Nasonex
Active Comparator
干预措施: fluticasone nasal spray (Drug)
结局指标
主要结局
Overall product preference based on subjects' answer to the question "which product do you prefer overall"
时间窗: On the study day, after dose of each product
次要结局
- Subject response to whether they preferred inhaled corticosteroid with or without aftertaste, and/or scent/odor,(On the study day, after dose of each product)
- Subject ratings for individual product attributes(On the study day, after dose of each product)
- Subject preference for glass or plastic bottle(On the study day, after dose of each product)
- Subject response to if they would want a prescription for their preferred product and if they would recommend the product(On the study day, after dose of each product)
- Subject rating for likely compliance with daily dosing,(On the study day, after dose of each product)
研究者
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