ProAir Digihaler in COPD Disease Management: A Real World Study to Assess ProAir Digihaler Inhalation Parameters Thresholds and Their Use to Identify Deterioration in Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- PIF Alerts and COPD Exacerbations
研究概览
简要总结
A pilot study to explore the utilization of the TEVA ProAir Digihaler rescue medication use and inhalation parameters to identify disease deterioration to help in the management of COPD patients in clinical practice. The study is designed to follow a small sample size of patients with COPD, monitor and collect inhalation parameters from the Digihaler dashboard, and changes in symptom control as measured by the COPD Assessment Test (CAT) to identify potential inhalation parameter thresholds that could be applied to the management of patients with COPD in clinical practice.
详细描述
The trial is an unblinded open label single center study designed to identify trends in Peak Inspiratory Flow (PIF) rates and Rescue Albuterol Inhaler usage (Inhalations) that associate with disease deterioration as defined by worsening of symptoms and reduced lung function in patients with COPD.
The study will consist of a run-in period of approximately 2 weeks, a treatment period of 6 months and a follow-up period of 1 week. Twenty (20) patients with COPD requiring intermittent short acting beta agonist (SABA) rescue inhaler usage, but not requiring frequent SABA nebulizer rescue usage, will be enrolled.
After signing informed consent, patients will undergo a screening evaluation. During the run-in period, patients will continue on their COPD maintenance treatments, while discontinuing all previously prescribed periodic use rescue medications. Upon completion of screening, all patients will be dispensed a ProAir Digihaler to be used exclusively as their rescue medication throughout the duration of the study. During the run-in period all rescue inhaler usage will be electronically monitored and patient data from the Digihaler Dashboard will be downloaded every other business day basis (Monday, Wednesday and Friday).
At the completion of at least 2 weeks of run-in (with a minimum of at least 8 rescue inhaler usages) and with documentation of stable clinical status throughout run-in, the patient will return for baseline testing; including vital signs, health related quality of life and Anthonisen Exacerbation questionnaires, pre and post bronchodilator spirometry and 6-minute walk testing (see table/flow chart). Average Peak Inspiratory Flow (Baseline PIF) and average Number of Rescue Inhalations per day (Baseline Inhalations) will be determined from the Digihaler Dashboard Data downloads during run-in.
In the event that the patient does not meet number of rescue inhaler usages or does not have a stable clinical status during run-in, an additional 2 weeks of run-in may be obtained. If at the end of the extended run-in period so that Baseline PIF and Baseline Inhalations cannot be determined or the patient continues to be clinically unstable, the patient will be discontinued from the study. If the patient has an upper respiratory tract infection or COPD exacerbation during run-in, they will also be discontinued from the study. Patients may be re-screened one time at a later date, when stable.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented history of COPD by ATS/GOLD criteria
- •Age > 45 years
- •Patient willing and able to:
- •participate in the study, including all scheduled visits
- •demonstrate the ability to use the ProAir Digihaler, including transfer of Digihaler data via blue-tooth to a smart device
- •perform all required testing, including spirometry and walk tests
- •complete all home questionnaires and participate in all telephone contacts
- •switch current rescue inhaler/device to ProAir Digihaler
- •Baseline spirometry consistent with COPD (post bronchodilator FEV1 < 80% predicted, FEV1/FVC <70%)
- •Use of albuterol inhaler as primary device for administration of rescue therapy
- •Reported use of rescue inhaler at least twice (4 inhalations) a week in the previous 6 months
- •Access to smartphone with blue-tooth and cellular/internet access
排除标准
- •Allergy, contraindication or inability to use albuterol sulfate
- •Frequent use of a nebulizer as rescue therapy (>1 time per day)
- •Current diagnosis of asthma
- •Unstable medical condition that could prevent the completion of the research trial
- •Pregnancy, planning to become pregnant or breast feeding
- •Failure to use rescue inhaler during Run-in period (minimum of at least 8 rescue inhaler inhalations over the 2 weeks)
- •Exacerbations that require discontinuation from study (during run-in period)
结局指标
主要结局
PIF Alerts and COPD Exacerbations
时间窗: 6 months
Presence of a Peak Inspiratory Flow (PIF) alert prior to a COPD Exacerbation Peak Inspiratory Flow (PIF) is the maximal inspiratory flow achieved during each patient inhalation of the Digihaler dry powder inhaler. PIF is automatically measured by the Digihaler dry powder inhaler during every inspiration of medication by a subject. Inspiratory flow is used to inhale respiratory medications into the lungs. A low inspiratory flow rate has been considered to place a COPD patient at risk for reducing medication inhalation and for other adverse outcomes. An acute fall in a patient's PIF may also be a marker of an impending change in a patient's condition. All acute COPD exacerbations were assessed by patient history, diaries and direct patient interviews. If a COPD Exacerbation had occurred, PIF measurements in the prior 2 weeks were assessed to determine if a PIF Alert, defined as a 20% fall in PIF from baseline for a minimum of 2 consecutive days, had occurred in the 2 weeks prior.
Low PIF Alerts and Worsening CAT Score
时间窗: 6 months
Presence of a Low Peak Inspiratory Flow (PIF) alert, defined by an 20% reduction in PIF from baseline for a minimum of 2 consecutive days occurring in the 2 weeks prior to a worsening of a subject COPD Assessment Test Score (CAT, score range 0-40, clinically important difference defined as a change in CAT score of 2 or more over time with an increase in value identifying worsening disease). Peak Inspiratory Flow (PIF) is the maximal inspiratory flow achieved during each patient inhalation of the Digihaler dry powder inhaler. PIF is automatically measured and recorded by the Digihaler device during every inspiration of medication with the device. All PIF measures in the 2 weeks prior to any worsening of CAT were assessed and a PIF alert was identified as being present if PIF fell by ≥20% from baseline on 2 or more consecutive days in the 2 weeks prior to a worsening of CAT score event.
次要结局
- Rescue SABA Puff Use Alerts and COPD Exacerbations(6 months)
- Low IV Alerts and COPD Exacerbations(6 months)