A Single Center, Open Label, Prospective Study Measuring Proportion of Patients With Suboptimal Peak Inspiratory Flow Rate (sPIFR) Over 24 Weeks in an Ambulatory Setting Among Moderate to Very Severe COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Occurrence of Suboptimal PIFR
研究概览
简要总结
Recent studies have reported that some Chronic Obstructive Pulmonary Disease (COPD) patients may have a suboptimal ability to generate a sufficient inspiratory effort to achieve adequate lung delivery of inhaled medications through dry powder inhalers. Sparse data is available about the inspiratory capacity of these patients in the home setting, whether clinically stable or when experiencing worsened respiratory symptoms outside the acute care setting. This study is undertaken to better understand the proportion of patients with suboptimal peak inspiratory flow rate (sPIFR) measurements amongst COPD patients receiving dry powder inhaler(s) (DPI) in the ambulatory setting. Further, the study will characterize PIFR over time, the variability of PIFR measurements, and the associations with potential predictors (demographics, clinical, Patient-Reported Outcomes (PRO), body position, and device) as well as exacerbations frequency and change in PIFR around period of exacerbation.
详细描述
Recent studies have reported that some COPD patients may have a suboptimal ability to generate a sufficient inspiratory effort to achieve adequate lung delivery of inhaled medications through dry powder inhalers. Sparse data is available about the inspiratory capacity of these patients in the home setting, whether clinically stable or when experiencing worsened respiratory symptoms outside the acute care setting. This study is undertaking this study to better understand the proportion of patients with suboptimal peak inspiratory flow rate (sPIFR) measurements amongst COPD patients receiving dry powder inhaler(s) (DPI) in the ambulatory setting. Further, the study will characterize PIFR over time, the variability of PIFR measurements, and the associations with potential predictors (demographics, clinical, PRO, body position, and device) as well as exacerbations frequency and change in PIFR around period of exacerbation. To complete these aims, 120 participants will be enrolled in a 6 month study to perform PIFR measurements and respiratory questionnaires at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 50 years-old
- •Spirometry-confirmed diagnosis of COPD (FEV1/FVC <0.70)
- •Global initiative for Chronic Obstructive Lung Disease (GOLD) II-IV based on spirometry results
- •COPD Assessment Test (CAT) score > 10
- •For high resistance DPI, baseline PIFR < 90 L/min (InCheck DIAL®) and >=30 L/min; for medium resistance DPI, PIFR ≤ 90 L/min (InCheck DIAL®) and >=60 L/min. Handihaler is a high resistance DPI. Examples of medium resistance DPI: Anoro, Incruse, Breo Ellipta®, Advair® Diskus® DP or Wixela® Inhub®
- •History of smoking tobacco products > 10 pack years
- •Prescribed at least one daily maintenance DPI with no change in prescription within the four weeks prior to the Enrollment Visit
- •One or more exacerbations of COPD requiring systemic corticosteroids within last 2 years
排除标准
- •Inability to demonstrate proper technique for the InCheck DIAL® device
- •Inability to achieve minimum PIFR for prescribed DPI(s) at screening/enrollment visit (< 30 L/min for e.g., Handihaler® (High resistance DPI), < 60 L/min for Ellipta® (Medium resistance DPI))
- •Inability to perform spirometry to meet American Thoracic Society standards
- •Neuromuscular disease associated with weakness
- •Any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study.
- •Pneumothorax within the past 4 weeks
- •For those participants who will require spirometry (i.e., if they have not had it within the past 3 months): Participants who present with a myocardial infarction or eye, chest or abdominal surgery within six weeks of baseline can be rescreened after the six week window has passed
结局指标
主要结局
Occurrence of Suboptimal PIFR
时间窗: 24 weeks
The occurrence of suboptimal Peak Inspiratory Flow Rate (sPIFR) over 24 weeks. sPIFR will be defined as any two consecutive measurements on different days below the optimal threshold for any prescribed DPI (e.g.,\<30 L/min for Handihaler® (High resistance DPI), \<60 L/min for Ellipta® (Medium resistance DPI))
次要结局
未报告次要终点