ProAir Digihaler in COPD Disease Management: A Real World Study

NCT04821869 | Completed Results FDA Drug FDA Device

• 1 other identifier: 002
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

A pilot study to explore the utilization of the TEVA ProAir Digihaler rescue medication use and inhalation parameters to identify disease deterioration to help in the management of COPD patients in clinical practice. The study is designed to follow a small sample size of patients with COPD, monitor and collect inhalation parameters from the Digihaler dashboard, and changes in symptom control as measured by the COPD Assessment Test (CAT) to identify potential inhalation parameter thresholds that could be applied to the management of patients with COPD in clinical practice.

Conditions

COPD; COPD Exacerbation Acute

Keywords

COPD; Digihaler; Rescue Medication; Disease Management

Outcome Measures

Primary Outcomes (2)

• PIF Alerts and COPD Exacerbations

  Presence of a Peak Inspiratory Flow (PIF) alert prior to a COPD Exacerbation Peak Inspiratory Flow (PIF) is the maximal inspiratory flow achieved during each patient inhalation of the Digihaler dry powder inhaler. PIF is automatically measured by the Digihaler dry powder inhaler during every inspiration of medication by a subject. Inspiratory flow is used to inhale respiratory medications into the lungs. A low inspiratory flow rate has been considered to place a COPD patient at risk for reducing medication inhalation and for other adverse outcomes. An acute fall in a patient's PIF may also be a marker of an impending change in a patient's condition. All acute COPD exacerbations were assessed by patient history, diaries and direct patient interviews. If a COPD Exacerbation had occurred, PIF measurements in the prior 2 weeks were assessed to determine if a PIF Alert, defined as a 20% fall in PIF from baseline for a minimum of 2 consecutive days, had occurred in the 2 weeks prior.

  6 months

• Low PIF Alerts and Worsening CAT Score

  Presence of a Low Peak Inspiratory Flow (PIF) alert, defined by an 20% reduction in PIF from baseline for a minimum of 2 consecutive days occurring in the 2 weeks prior to a worsening of a subject COPD Assessment Test Score (CAT, score range 0-40, clinically important difference defined as a change in CAT score of 2 or more over time with an increase in value identifying worsening disease). Peak Inspiratory Flow (PIF) is the maximal inspiratory flow achieved during each patient inhalation of the Digihaler dry powder inhaler. PIF is automatically measured and recorded by the Digihaler device during every inspiration of medication with the device. All PIF measures in the 2 weeks prior to any worsening of CAT were assessed and a PIF alert was identified as being present if PIF fell by ≥20% from baseline on 2 or more consecutive days in the 2 weeks prior to a worsening of CAT score event.

  6 months

Secondary Outcomes (2)

• Rescue SABA Puff Use Alerts and COPD Exacerbations

  6 months

• Low IV Alerts and COPD Exacerbations

  6 months

Interventions

ProAir Digihaler DRUG

Monitor parameters transmitted from the Proair Digihaler to the Digihaler Dashboard, including peak inspiratory Flow, inspiratory volume and frequency of rescue use

Also known as: Digihaler Device

Digihaler DEVICE

Monitor parameters transmitted from the Proair Digihaler to the Digihaler Dashboard, including peak inspiratory Flow, inspiratory volume and frequency of rescue use

Also known as: Digihaler Dashboard

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with COPD

You may qualify if:

• Documented history of COPD by ATS/GOLD criteria
• Age \> 45 years
• Patient willing and able to:
• participate in the study, including all scheduled visits
• demonstrate the ability to use the ProAir Digihaler, including transfer of Digihaler data via blue-tooth to a smart device
• perform all required testing, including spirometry and walk tests
• complete all home questionnaires and participate in all telephone contacts
• switch current rescue inhaler/device to ProAir Digihaler
• Baseline spirometry consistent with COPD (post bronchodilator FEV1 \< 80% predicted, FEV1/FVC \<70%)
• Use of albuterol inhaler as primary device for administration of rescue therapy
• Reported use of rescue inhaler at least twice (4 inhalations) a week in the previous 6 months
• Access to smartphone with blue-tooth and cellular/internet access

You may not qualify if:

• Allergy, contraindication or inability to use albuterol sulfate
• Frequent use of a nebulizer as rescue therapy (\>1 time per day)
• Current diagnosis of asthma
• Unstable medical condition that could prevent the completion of the research trial
• Pregnancy, planning to become pregnant or breast feeding
• Failure to use rescue inhaler during Run-in period (minimum of at least 8 rescue inhaler inhalations over the 2 weeks)
• Exacerbations that require discontinuation from study (during run-in period)

Sponsors & Collaborators

• Pulmonary Research Institute of Southeast Michigan: lead
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator

Study Sites (1)

Pulmonary Research Institute of Southeast Michigan

Farmington Hills, Michigan, 48336, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Limitations and Caveats

This study was not designed for or intended to evaluate the use of the Digihaler to predict future clinical events in COPD patients. Rather, it was a non-powered exploratory pilot study designed to provide preliminary information and insights that might serve as the basis for future studies to assess whether the use of rescue albuterol in a digital inhaler device could be used as a predictive tool.

Results Point of Contact

• Title: Gary T Ferguson, MD, Director
• Organization: Pulmonary Research Institute of Southeast MIchigan

garytferguson@msn.com

248-478-6908

Study Officials

• Gary T Ferguson, M.D.

  Pulmonary Research Institute of Southeast Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 30, 2021
• Study Start: May 10, 2021
• Primary Completion: June 21, 2022
• Study Completion: June 21, 2022
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)