ProAir Digihaler in COPD Disease Management: A Real World Study (NCT04821869) | Clinical Trial Compass
CompletedNot Applicable
ProAir Digihaler in COPD Disease Management: A Real World Study
United States27 participantsStarted 2021-05-10
Plain-language 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.
Who can participate
Age range
45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PIF Alerts and COPD Exacerbations
Timeframe: 6 months
2
Low PIF Alerts and Worsening CAT Score
Timeframe: 6 months
Trial details
NCT IDNCT04821869
SponsorPulmonary Research Institute of Southeast Michigan