N/A
Completed N=27
ProAir Digihaler in COPD Disease Management: A Real World Study
Chronic Obstructive Pulmonary Disease · COPD Exacerbation Acute
Source: ClinicalTrials.gov NCT04821869 ↗
Enrolled (actual)
27
Serious AEs
11.1%
Results posted
Jun 2025
Primary outcomePrimary: PIF Alerts and COPD Exacerbations — 2 Low PIF Alert
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PIF Alerts and COPD Exacerbations |
2 | — |
| PRIMARY Low PIF Alerts and Worsening CAT Score |
3 | — |
| SECONDARY Rescue SABA Puff Use Alerts and COPD Exacerbations |
— | — |
| SECONDARY Low IV Alerts and COPD Exacerbations |
4 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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)
Data sourced from ClinicalTrials.gov (NCT04821869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.