Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases, Albuterol, Bronchodilator Agents, Respiratory System Agents
Brief summary
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.
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.
Interventions
COMBINATION_PRODUCTAlbuterol eMDPI DS
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)
Sponsors
Wake Forest University Health Sciences
Teva Branded Pharmaceutical Products R&D, Inc.
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study.
Intervention model description
All participants will receive the intervention consisting of Albuterol eMDPI DS (ProAir® Digihaler®). Participants will be asked to use the ProAir Digihaler as their primary mode of SABA therapy as they would in usual treatment and indicated in the product package insert and Instructions for Use. They will answer a daily self-assessment on the DAQ App, as well as Digihaler metric algorithm-triggered DAQ on the DAQ app. The DAQ will collect yes/no responses to questions focused on change in symptoms. The participants will be contacted once per month to collect COPD Assessment Test (CAT) score and self-reported average albuterol use over the preceding month. They will also be asked about any AECOPD events requiring treatment.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Variability in Peak Inspiratory Flow (PIF) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Variability in Inhalation Volume | 3 months | 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. |
| Variability in Inhalation Volume as Measured by Coefficient of Variation | 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. |
| Correlation of Self-Reported Inhaler Use With Actual Inhaler Use | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Albuterol eMDPI DS (ProAir® Digihaler®) This arm will receive the intervention of the Albuterol eMDPI DS for three months.
Albuterol eMDPI DS: 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) | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Albuterol eMDPI DS (ProAir® Digihaler®) |
|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 7.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Region of Enrollment United States | 40 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 54 |
| other Total, other adverse events | 8 / 54 |
| serious Total, serious adverse events | 5 / 54 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albuterol eMDPI DS (ProAir® Digihaler®) | Mean Variability in Peak Inspiratory Flow (PIF) | 67.6 Liters/minute | Standard Deviation 20.3 |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Albuterol eMDPI DS (ProAir® Digihaler®) | Variability in Peak Inspiratory Flow (PIF) as Measured by Coefficient of Variation | 0.286 Correlation coefficient |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Albuterol eMDPI DS (ProAir® Digihaler®) | Correlation of Self-Reported Inhaler Use With Actual Inhaler Use | -0.385 Correlation coefficient |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albuterol eMDPI DS (ProAir® Digihaler®) | Mean Variability in Inhalation Volume | 1.395 Liters | Standard Deviation 0.598 |
Secondary
Variability in Inhalation Volume as Measured by Coefficient of Variation
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.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Albuterol eMDPI DS (ProAir® Digihaler®) | Variability in Inhalation Volume as Measured by Coefficient of Variation | 0.426 Correlation coefficient |