MedTrace Logo

ProAir Digihaler in COPD Disease Management: A Real World Study

NCT04821869 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 27

Last updated 2025-06-13

Study results available
· View outcomes & findings →

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

Interventions

DRUG

ProAir Digihaler

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

DEVICE

Digihaler

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

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    collaborator INDUSTRY

  • Pulmonary Research Institute of Southeast Michigan

    lead OTHER

Principal Investigators

  • Gary T Ferguson, M.D. · Pulmonary Research Institute of Southeast Michigan

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-10
Primary Completion
2022-06-21
Completion
2022-06-21
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04821869 on ClinicalTrials.gov