Digihaler in Chronic Obstructive Pulmonary Disease (COPD)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- University of North Carolina at Chapel Hill
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Baptist Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Albuterol eMDPI DS (ProAir® Digihaler®)
This arm will receive the intervention of the Albuterol eMDPI DS for three months.
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Albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) Digital System (DS) with 3 component devices: Device 1: Albuterol eMDPI Device 2: Albuterol eMDPI Patient-facing smart device application (App) Device 3: Digital Health Platform (DHP, Cloud solution)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Variability in Peak Inspiratory Flow (PIF)
Time Frame: 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.
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3 months
|
|
Variability in Peak Inspiratory Flow (PIF) as Measured by Coefficient of Variation
Time Frame: 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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation of Self-Reported Inhaler Use With Actual Inhaler Use
Time Frame: 3 months
|
Correlation between self-reported inhaler use and actual inhaler use over three months will be calculated with Spearman rank-order correlation coefficient.
Self-reported inhaler use will be determined with an investigator-developed single question categorizing average use over the last four weeks with five groups (not at all, once a week or less, two or three times a week, one or two times a day, three or more times a day).
Actual inhaler use will be directly measured via Digihaler device and categorized into one of the five groups described above.
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3 months
|
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Mean Variability in Inhalation Volume
Time Frame: 3 months
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Inhalation volume is the volume of air inspired during an inhalation effort, expressed in Liters.
The mean and standard deviation of daily inhalation volume measurements collected daily over three months will be calculated.
Inhalation volume will be measured using the Digihaler device.
|
3 months
|
|
Variability in Inhalation Volume as Measured by Coefficient of Variation
Time Frame: 3 months
|
Inhalation volume is the volume of air inspired during an inhalation effort, expressed in Liters.
Coefficient of variation (calculated by dividing standard deviation of inhalation volume by the mean of the inhalation volume) of daily inhalation volume measurement collected over three months will be calculated.
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3 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Michael B Drummond, MD, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Disease Attributes
- Chronic Disease
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Albuterol
Other Study ID Numbers
- 21-0273
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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