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| Name | Class |
|---|---|
| Wake Forest University Health Sciences | OTHER |
| Teva Branded Pharmaceutical Products R&D, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albuterol eMDPI DS (ProAir® Digihaler®) | Experimental | This arm will receive the intervention of the Albuterol eMDPI DS for three months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albuterol eMDPI DS | Combination 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael B Drummond, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | United States | ||
| Wake Forest University Baptist Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Data presented for those participants with both primary and secondary outcome data.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Liters/minute | 3 months |
|
From signing of informed consent throughout duration of study, a total of approximately 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COPD Exacerbation with hospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael B Drummond, MD | University of North Carolina at Chapel Hill | 919-966-7054 | brad_drummond@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2022 | Dec 14, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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This is an open-label study.
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|
|
| 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. | 3 months |
| 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. | 3 months |
| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Posted | Number | 95% Confidence Interval | Correlation coefficient | 3 months |
|
|
|
| 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. | Posted | Number | 95% Confidence Interval | Correlation coefficient | 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Liters | 3 months |
|
|
|
| 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. | Posted | Number | 95% Confidence Interval | Correlation coefficient | 3 months |
|
|
|
| 1 |
| 54 |
| 5 |
| 54 |
| 8 |
| 54 |
| Metastatic Lung Cancer | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Progression of known lung cancer leading to death. |
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| Tremors | Nervous system disorders | Systematic Assessment |
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| Oral Candidiasis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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