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 range45 Years
SexALL
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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
Exclusion criteria
✕. Allergy, contraindication or inability to use albuterol sulfate
✕. Frequent use of a nebulizer as rescue therapy (\>1 time per day)
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