Peak Inspiratory Flow (PIF) and Dry Powder Inhaler (DPI) Performance in Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- DPI Responder Analysis in Patients With Suboptimal PIF (<60 L/Min)
研究概览
简要总结
The purpose of the study is to determine whether PIF is clinically important when using the Ellipta DPI device. In addition, the study will validate the best/most clinically appropriate way to perform a PIF maneuver, to determine the testing capabilities of the preferred PIF maneuver and to relate this PIF measurement to meaningful clinical outcomes in COPD patients
详细描述
Study Design and Methods Rationale
- The expected FEV1 response to a bronchodilator is uncertain as multiple factors influence this measure, including severity of disease, day to day variability, varying reversibility in COPD patients, the delivery of the drug to a patient and the effectiveness of the medication delivered. Thus, the measurement of an acute bronchodilator response after delivering a long acting bronchodilator may not identify whether a medication has been effectively delivered to a patient.
- However, if a long acting bronchodilator has not been effectively delivered to the lung, then subsequent delivery of a short acting bronchodilator should produce a significant additional bronchodilator response. On the other hand, if a long acting bronchodilator has been effectively delivered to the lung, then subsequent delivery of a short acting bronchodilator should not produce any further significant bronchodilation.
- Based on this rationale, comparison of the acute bronchodilator response to a short acting bronchodilator after receiving a long acting should identify whether drug delivery is ineffective in a selected patient population, irrespective of baseline FEV1 and of any partial response to the long acting bronchodilator. Comparison of the short acting bronchodilator measurement between patient groups with differing PIF thresholds should identify whether PIF has an impact of drug delivery of a long acting bronchodilator via a DPI.
- Open label design comparing the acute bronchodilator response after delivery of a long acting bronchodilator via Ellipta DPI in patients with normal, suboptimal and minimal PIF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •smoking history >10 pack years
- •pre-bronchodilator FEV1 <60% predicted
- •post-bronchodilator FEV1/FVC <70%
- •female participants are eligible to participate if they are not pregnant, not breastfeeding, and at least one of the following conditions applies:
- •not a woman of childbearing potential OR
- •agree to follow the contraceptive guidance during the treatment period and until the safety follow-up contact after the last dose of study treatment
- •stratification requiring at least 1/3 of patients having a PIF of < 60L/min (AM pre-dose based on using the level 2 InCheck Dial resistance setting with a sharp maximal effort starting after exhaling fully)
排除标准
- •any subject with unstable disease, including
- •COPD exacerbation in the last 6 weeks
- •upper respiratory tract in in the last 4 weeks
- •COPD or upper respiratory tract infection during run-in (subjects may be re-screened x 1 when stable after an acute event)
- •pulmonary disease other than COPD
- •any lung resection
- •unstable cardiac conditions (at the discretion of the investigator)
- •other unstable medical conditions (at the discretion of the investigator)
研究组 & 干预措施
Open label treatment
All subjects receive Trelegy and Ventolin for 2 weeks
干预措施: Trelegy Ellipta 100/62.5/25Mcg Inh 30D (Drug)
Open label treatment
All subjects receive Trelegy and Ventolin for 2 weeks
干预措施: Ventolin 90Mcg/Actuation Inhalation Aerosol (Drug)
结局指标
主要结局
DPI Responder Analysis in Patients With Suboptimal PIF (<60 L/Min)
时间窗: 2 weeks
Outcome = the number of subject test days (2 test days per subject) meeting responder criteria defined as: DPI Responder - a positive (\>50 ml) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (\<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Partial Responder a positive (\>50 ml) peak FEV1 response 2 hours after Trelegy® Ellipta DPI with a positive (\>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Failure - a negative (\<50mL) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a positive (\>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) Irreversible - a negative (\<50mL) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (\<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy)
次要结局
- PIF Measurement Techniques(Baseline on day of testing)
- DPI Responder Analysis in Patients With Reduced PIF (<45 L/Min)(2 weeks)