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NCT04821869 · ClinicalTrials.gov registry record
ProAir Digihaler in COPD Disease Management: A Real World Study
A clinical trial, sponsored by Pulmonary Research Institute of Southeast Michigan.
- Completed
- Registry status
- 27
- Enrollment target
NCT04821869: Completed study, sponsored by Pulmonary Research Institute of Southeast Michigan.
NCT04821869 is a clinical trial that has completed, run by Pulmonary Research Institute of Southeast Michigan. The registered enrollment target is 27 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04821869 has completed, sponsored by Pulmonary Research Institute of Southeast Michigan.
- COMPLETED
- Registry status
- 27 participants
- Enrollment target
Study 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.
Primary Outcome
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 reducin
Interventions
- DRUG ProAir Digihaler
- DEVICE Digihaler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2021-05-10 |
| Est. Completion | 2022-06-21 |
What the finished NCT04821869 record still lists
NCT04821869 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 27 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which ProAir Digihaler is the first listed.
NCT04821869 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04821869 about?
NCT04821869 is a clinical study titled "ProAir Digihaler in COPD Disease Management: A Real World Study". 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 ...
What is the current status of trial NCT04821869?
This trial is currently completed. The enrollment target is 27 participants. The study started on 2021-05-10. Estimated completion is 2022-06-21.
What interventions are being tested in trial NCT04821869?
The interventions under investigation include: ProAir Digihaler (DRUG), Digihaler (DEVICE).
Who is sponsoring clinical trial NCT04821869?
This trial is sponsored by Pulmonary Research Institute of Southeast Michigan, which has 2 total clinical trials registered on ClinicalTrials.gov.
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