Digihaler in Chronic Obstructive Pulmonary Disease (COPD)

Not Applicable

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Combination Product: Albuterol eMDPI DS

• Registration Number: NCT05241288
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2022-02-04
• Study First Submitted QC: 2022-02-04
• Study First Posted: 2022-02-15
• Study Start: 2022-03-01
• Primary Completion: 2023-02-13
• Study Completion: 2023-02-13
• Status Verified: 2023-04
• Results First Submitted: 2024-01-02
• Results First Submitted QC: 2024-01-02
• Last Update Submitted: 2024-01-02
• Results First Posted: 2024-01-23
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Albuterol eMDPI DS (ProAir® Digihaler®)	Albuterol eMDPI DS	This arm will receive the intervention of the Albuterol eMDPI DS for three months.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

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