Pilot Study to Examine the Post-Dose Changes in Exhaled Nitric Oxide (eNO) Following Treatment With Fluticasone Propionate (FP)/Salmeterol (SAL) Combination Product Advair
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sandoz
- 入组人数
- 105
- 试验地点
- 6
- 主要终点
- Percentage Change From Baseline (for Each Treatment Cycle) in Exhaled Nitric Oxide (eNO)
研究概览
简要总结
To examine the post-dose changes in exhaled Nitric Oxide (eNO) following treatment with inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for Asthma (GINA) guidelines.
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
- •must be able to speak, read, and understand English
- •exhaled Nitrous Oxide levels must be greater than or equal to 60 ppb at screening and greater than or equal to 55 ppb at Visits 2, 9, and 16
- •must have history of at least 6 months of chronic, but stable asthma
- •except for the presence of asthma, subjects must be in general good health
排除标准
- •past or present history of experiencing allergic reaction to medications used in this study
- •subjects must not be receiving ongoing regular treatment with inhaled corticosteroids
- •subjects must not have ragweed allergy
- •subjects must have no recent history of respiratory infections for at least 1 month prior to screening and until the end of the study
结局指标
主要结局
Percentage Change From Baseline (for Each Treatment Cycle) in Exhaled Nitric Oxide (eNO)
时间窗: Baseline to Day 7 of each treatment cycle (total duration about 8 - 10 weeks)
Percentage change in eNO was reported following treatment with inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for Asthma (GINA) guidelines. eNO was calculated 3 times every day in a treatment cycle for 7 days. The maximum value of all 3 collected value were collected for each seven days of the individual treatment cycle. Out of the maximum values, the minimum was taken and used for calculating the percentage change from baseline.
次要结局
未报告次要终点