Digihaler in Chronic Obstructive Pulmonary Disease (COPD)

NCT05241288 | Completed Results FDA Device

• 1 other identifier: 21-0273
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Albuterol; Bronchodilator Agents; Respiratory System Agents

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Correlation of Self-Reported Inhaler Use With Actual Inhaler Use

  3 months

• Mean Variability in Inhalation Volume

  3 months

• Variability in Inhalation Volume as Measured by Coefficient of Variation

  3 months

Study Arms (1)

Albuterol eMDPI DS (ProAir® Digihaler®)

EXPERIMENTAL

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

Combination Product: Albuterol eMDPI DS

Interventions

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)

Also known as: ProAir® Digihaler®

Albuterol eMDPI DS (ProAir® Digihaler®)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Wake Forest University Health Sciences: collaborator
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator

Study Sites (2)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michael B Drummond, MD
• Organization: University of North Carolina at Chapel Hill

brad_drummond@med.unc.edu

919-966-7054

Study Officials

• Michael B Drummond, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 15, 2022
• Study Start: March 1, 2022
• Primary Completion: February 13, 2023
• Study Completion: February 13, 2023
• Last Updated: January 23, 2024
• Results First Posted: January 23, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)