Digihaler in Chronic Obstructive Pulmonary Disease (COPD)

University of North Carolina (UNC)

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Combination Product: Albuterol eMDPI DS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05241288

21-0273

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Albuterol eMDPI DS (ProAir® Digihaler®)

Experimental group

Description:

This arm will receive the intervention of the Albuterol eMDPI DS for three months.

Treatment:

Combination Product: Albuterol eMDPI DS