Digihaler in Chronic Obstructive Pulmonary Disease (COPD)

University of North Carolina, Chapel Hill54 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Albuterol eMDPI DSCOMBINATION_PRODUCT

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)

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (2)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Mean Variability in Peak Inspiratory Flow (PIF)

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.

Time frame: 3 months

Variability in Peak Inspiratory Flow (PIF) as Measured by Coefficient of Variation

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.

Time frame: 3 months

Secondary Outcomes

Correlation of Self-Reported Inhaler Use With Actual Inhaler Use

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.

Time frame: 3 months

Mean Variability in Inhalation Volume

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.

Time frame: 3 months

Variability in Inhalation Volume as Measured by Coefficient of Variation

Data from ClinicalTrials.gov

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