Use of ProAir Digihaler in Chronic Obstructive Pulmonary Disease (COPD) - Characterization of Inhalation Metrics From a Cohort of Patient At-risk for Acute Exacerbation of COPD (AECOPD) in an Outpatient Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Mean Variability in Peak Inspiratory Flow (PIF)
研究概览
简要总结
This is a multi-center 3-month study to determine the variation in ProAir Digihaler metrics [peak inspiratory flow (PIF), inhalation volume, number of inhalation events] amongst COPD patients in the ambulatory setting.
详细描述
The albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) Digital System (DS) (ProAir® Digihaler®) is the first and only Food and Drug Administration (FDA) approved inhaler rescue medication with a built-in sensor to detect and record inhaler use. The inhaler device measures PIF and the app groups PIF into categories that can help to highlight potential patient inhaler technique errors. This study will deploy this product in COPD patients to establish foundational data on Digihaler metrics in a COPD population at greater risk for COPD exacerbations.
Adult subjects with COPD recruited from two sites [University of North Carolina (UNC) and Wake Forest] will participate in a longitudinal study to collect data regarding the normal variation in Digihaler metrics (PIF, inhalation volume, number of inhalations), a daily self-assessment asking "How are you feeling?" with responses provided on a Likert scale as well as responses to a Digihaler metric algorithm-triggered digital automated questionnaire (DAQ) in a stable COPD population with history of an AECOPD, to assess correlations of Digihaler metrics to daily self-assessment and DAQ responses, correlations of self-reported to actual short acting beta agonist (SABA) use and symptoms, and the changes in inhaler parameters and SABA use around incidental AECOPD.
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
盲法说明
This is an open-label study.
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
- •Age >40 years old
- •History of cigarette smoking >=10 pack-years
- •Established COPD defined as physician diagnosis along with spirometry confirmation [post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC)<0.70] within the last two years and an FEV1 ≤80% predicted
- •Regular albuterol use (defined as at least one puff weekly for each of the last four weeks)
- •Currently non-hospitalized
- •Medical records confirmed history of two moderate AECOPD (defined as use of antibiotic or steroids to treat clinical event consistent with AECOPD) or one severe AECOPD (defined as emergency department/hospital visit) in prior 12 months
- •Access to smart phone, tablet or computer and internet
- •Willingness to switch current rescue inhaler/device to ProAir Digihaler
排除标准
- •Allergy or inability/contraindication to use Albuterol Sulfate
- •Any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study
研究组 & 干预措施
Albuterol eMDPI DS (ProAir® Digihaler®)
This arm will receive the intervention of the Albuterol eMDPI DS for three months.
干预措施: Albuterol eMDPI DS (Combination Product)
结局指标
主要结局
Mean Variability in Peak Inspiratory Flow (PIF)
时间窗: 3 months
PIF is the maximal flow occurring during an inhalation effort, expressed in Liters/minute. Mean and standard deviation of daily PIF measurement collected over three months will be calculated. PIF will be measured using the Digihaler device.
Variability in Peak Inspiratory Flow (PIF) as Measured by Coefficient of Variation
时间窗: 3 months
PIF is the maximal flow occurring during an inhalation effort, expressed in Liters/minute. Coefficient of variation (calculated by dividing standard deviation of PIF by the mean of the PIF) of daily PIF measurement collected over three months will be calculated. PIF will be measured using the Digihaler device.
次要结局
- Correlation of Self-Reported Inhaler Use With Actual Inhaler Use(3 months)
- Mean Variability in Inhalation Volume(3 months)
- Variability in Inhalation Volume as Measured by Coefficient of Variation(3 months)