Clinical trial NCT05241288: Digihaler in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Use of ProAir Digihaler in Chronic Obstructive Pulmonary Disease (COPD) - Characterization of Inhalation Metrics From a Cohort of Patient At-risk for Acute Exacerbation of COPD (AECOPD) in an Outpatient Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Albuterol
Bronchodilator Agents
Respiratory System Agents
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Wake Forest University Health Sciences
name: Teva Branded Pharmaceutical Products R&D, Inc.
First posted: 2022-02-15
Enrollment: 54
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Variability in Peak Inspiratory Flow (PIF)
timeFrame: 3 months
measure: Variability in Peak Inspiratory Flow (PIF) as Measured by Coefficient of Variation
timeFrame: 3 months
Secondary outcomes:
measure: Correlation of Self-Reported Inhaler Use With Actual Inhaler Use
timeFrame: 3 months
measure: Mean Variability in Inhalation Volume
timeFrame: 3 months
measure: Variability in Inhalation Volume as Measured by Coefficient of Variation
timeFrame: 3 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Michael B Drummond, MD
role: PRINCIPAL_INVESTIGATOR
References: